Measuring Instruments Regulations, 2016

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 19,556, 12 ta’ April, 2016

L.N 122 of 2016

METROLOGY ACT

(CAP. 454)

Measuring Instruments Regulations, 2016

In exercise of the powers conferred by article 19 of the

Metrology Act, the Minister for Social Dialogue, Consumer Affairs

and Civil Liberties, acting on the advice of the Malta Competition and

Consumer affairs Authority, has made the following regulations:-

(1) The title of these regulations is the Measuring Citation, scope

and

Instrument Regulations, 2016.

commencement.

(2) These regulations shall come into force on the 20th April,

2016. (3) These regulations implement Directive 2014/32/EU of the

European Parliament and of the Council of 26 February 2014 on the

harmonisation of the laws of the Member States relating to the

making available on the market of measuring instruments (recast).

(4) These regulations apply to the measuring instruments

defined in the instrument-specific Schedules III to XII (hereinafter

referred to as "instrument-specific Schedules") concerning water

meters (MI-001), gas meters and volume conversion devices (MI-

002), active electrical energy meters (MI-003), thermal energy meters

(MI-004), measuring systems for continuous and dynamic

measurement of quantities of liquids other than water (MI-005),

automatic weighing instruments (MI-006), taxi-meters (MI-007),

material measures (MI-008), dimensional measuring instruments

(MI-009) and exhaust gas analysers (MI-010).

(5) These regulations shall apply with respect to requirements

for electromagnetic immunity within the meaning of Article 2(3) of

Directive 2014/30/EU of the European Parliament and of the Council

(1) which provisions continue to apply with regard to emission

requirements.

ESSENTIAL REQUIREMENTS

A measuring instrument shall provide a high level of metrological protection

in order that any party affected can have confidence in the result of

measurement, and shall be designed and manufactured to a high level of

quality in respect of the measurement technology and security of the

measurement data.

The essential requirements that shall be met by measuring instruments are set

out below and are supplemented, where appropriate, by specific instrument

requirements in Schedules III to XII that provide more detail on certain

aspects of the general requirements.

The solutions adopted in the pursuit of the essential requirements shall take

account of the intended use of the instrument and any foreseeable misuse

The measurand is the particular quantity subject to

measurement.

An influence quantity is a quantity that is not the

measurand but that affects the result of measurement.

The rated operating conditions are the values for the

measurand and influence quantities making up the normal

working conditions of an instrument.

An influence quantity having a value within the limits

specified in the appropriate requirement but outside the

specified rated operating conditions of the measuring

instrument. An influence quantity is a disturbance if for

that influence quantity the rated operating conditions are

not specified.

The critical change value is the value at which the change

in the measurement result is considered undesirable.

A material measure is a device intended to reproduce or

supply in a permanent manner during its use one or more

known values of a given quantity.

Direct sales

A trading transaction is direct sales if

-

the measurement result serves as the basis

for the price to pay; and

-

at least one of the parties involved in the

transaction related to measurement is a

consumer or any other party requiring a

similar level of protection; and

-

all the parties in the transaction accept the

measurement result at that time and place.

Climatic

Climatic environments are the conditions in which

environments

measuring instruments may be used. To cope with

climatic differences between the Member States, a range

of temperature limits has been defined.

Utility

A utility is regarded as a supplier of electricity, gas,

thermal energy or water.

ESSENTIAL REQUIREMENTS

1. Allowable Errors

(1)

Under rated operating conditions and in the absence of a disturbance, the

error of measurement shall not exceed the maximum permissible error (MPE)

value as laid down in the appropriate instrument-specific requirements.

Unless stated otherwise in the instrument-specific schedules, MPE is

expressed as a bilateral value of the deviation from the true measurement

value.

(2)

Under rated operating conditions and in the presence of a disturbance, the

performance requirement shall be as laid down in the appropriate instrument-

specific requirements.

Where the instrument is intended to be used in a specified permanent

continuous electromagnetic field the permitted performance during the

radiated electromagnetic field-amplitude modulated test shall be within MPE.

(3)

The manufacturer shall specify the climatic, mechanical and electromagnetic

environments in which the instrument is intended to be used, power supply

and other influence quantities likely to affect its accuracy, taking account of

the requirements laid down in the appropriate instrument-specific schedules.

(3.1) Climatic environments

The manufacturer shall specify the upper temperature limit and the lower

temperature limit from any of the values in Table 1 unless otherwise specified

in the Schedules III to XII, and indicate whether the instrument is designed

for condensing or non-condensing humidity as well as the intended location

for the instrument, i.e. open or closed.

Temperature Limits

Upper temperature limit

30°C

40°C

55°C

70°C

Lower temperature limit

5°C

– 10°C

– 25°C

– 40°C

(3.2). (a) Mechanical environments are classified into classes M1 to M3 as

described below.

This class applies to instruments used in locations with vibration

and shocks of low significance, e.g. for instruments fastened to

light supporting structures subject to negligible vibrations and

shocks transmitted from local blasting or pile-driving activities,

slamming doors, etc.

This class applies to instruments used in locations with significant

or high levels of vibration and shock, e.g. transmitted from

machines and passing vehicles in the vicinity or adjacent to heavy

machines, conveyor belts, etc.

This class applies to instruments used in locations where the level

of vibration and shock is high and very high, e.g. for instruments

mounted directly on machines, conveyor belts, etc.

(b) The following influence quantities shall be considered in relation with

mechanical environments

Vibration;

Mechanical shock.

(3.3). (a) Electromagnetic environments are classified into classes E1, E2 or E3 as

described below, unless otherwise laid down in the appropriate instrument-

specific schedules.

This class applies to instruments used in locations with

electromagnetic disturbances corresponding to those likely to be

found in residential, commercial and light industrial buildings.

This class applies to instruments used in locations with

electromagnetic disturbances corresponding to those likely to be

found in other industrial buildings.

This class applies to instruments supplied by the battery of a vehicle.

Such instruments shall comply with the requirements of E2 and the

following additional requirements

-

voltage reductions caused by energising the starter-

motor circuits of internal combustion engines,

-

load dump transients occurring in the event of a

discharged battery being disconnected while the engine

is running.

(b) The following influence quantities shall be considered in relation with

electromagnetic environments

voltage interruptions;

short voltage reductions;

voltage transients on supply lines and/or signal lines;

electrostatic discharges

radio frequency electromagnetic fields;

conducted radio frequency electromagnetic fields on supply lines and/

or signal lines;

surges on supply lines and/or signal lines.

(3.4) Other influence quantities to be considered, where appropriate, are

voltage variation;

mains frequency variation;

power frequency magnetic fields;

any other quantity likely to influence in a significant way the accuracy

of the instrument.

(4)

When carrying out the tests as envisaged in these regulations, the following

points shall apply

(4.1). Basic rules for testing and the determination of errors

Essential requirements specified in points 1.1 and 1.2 shall be verified for

each relevant influence quantity. Unless otherwise specified in the

appropriate instrument-specific schedules, these essential requirements apply

when each influence quantity is applied and its effect evaluated separately, all

other influence quantities being kept relatively constant at their reference

value.

Metrological tests shall be carried out during or after the application of the

influence quantity, whichever condition corresponds to the normal

operational status of the instrument when that influence quantity is likely to

occur.

(4.2) Ambient humidity

(a) According to the climatic operating environment in which the instrument

is intended to be used either the damp heat-steady state (non-

condensing) or damp heat cyclic (condensing) test may be appropriate.

(b) The damp heat cyclic test is appropriate where condensation is important

or when penetration of vapour will be accelerated by the effect of

breathing. In conditions where non-condensing humidity is a factor the

damp- heat steady state is appropriate.

2. Reproducibility

The application of the same measurand in a different location or by a

different user, all other conditions being the same, shall result in the close

agreement of successive measurements. The difference between the

measurement results shall be small when compared with the MPE.

3. Repeatability

The application of the same measurand under the same conditions of

measurement shall result in the close agreement of successive measurements.

The difference between the measurement results shall be small when

compared with the MPE.

4. Discrimination and Sensitivity

A measuring instrument shall be sufficiently sensitive and the discrimination

threshold shall be sufficiently low for the intended measurement task.

5. Durability

A measuring instrument shall be designed to maintain an adequate stability of

its metrological characteristics over a period of time estimated by the

manufacturer, provided that it is properly installed, maintained and used

according to the manufacturer’s instruction when in the environmental

conditions for which it is intended.

6. Reliability

A measuring instrument shall be designed to reduce as far as possible the

effect of a defect that would lead to an inaccurate measurement result, unless

the presence of such a defect is obvious.

7. Suitability

(1)

A measuring instrument shall have no feature likely to facilitate fraudulent

use, whereas possibilities for unintentional misuse shall be minimal.

(2)

A measuring instrument shall be suitable for its intended use taking account

of the practical working conditions and shall not require unreasonable

demands of the user in order to obtain a correct measurement result.

(3)

The errors of a utility measuring instrument at flows or currents outside the

controlled range shall not be unduly biased.

(4)

Where a measuring instrument is designed for the measurement of values of

the measurand that are constant over time, the measuring instrument shall be

insensitive to small fluctuations of the value of the measurand, or shall take

appropriate action.

(5)

A measuring instrument shall be robust and its materials of construction shall

be suitable for the conditions in which it is intended to be used.

(6)

A measuring instrument shall be designed so as to allow the control of the

measuring tasks after the instrument has been placed on the market and put

into use. If necessary, special equipment or software for this control shall be

part of the instrument. The test procedure shall be described in the operation

manual.

When a measuring instrument has associated software which provides other

functions besides the measuring function, the software that is critical for the

metrological characteristics shall be identifiable and shall not be inadmissibly

influenced by the associated software.

8. Protection against corruption

(1)

The metrological characteristics of a measuring instrument shall not be

influenced in any inadmissible way by the connection to it of another device,

by any feature of the connected device itself or by any remote device that

communicates with the measuring instrument.

(2)

A hardware component that is critical for metrological characteristics shall be

designed so that it can be secured.

Security measures foreseen shall provide for evidence of an intervention.

(3)

Software that is critical for metrological characteristics shall be identified as

such and shall be secured.

Software identification shall be easily provided by the measuring instrument.

Evidence of an intervention shall be available for a reasonable period of time.

(4)

Measurement data, software that is critical for measurement characteristics

and metrologically important parameters stored or transmitted shall be

adequately protected against accidental or intentional corruption.

(5)

For utility measuring instruments the display of the total quantity supplied or

the displays from which the total quantity supplied can be derived, whole or

partial reference to which is the basis for payment, shall not be able to be

reset during use.

9. Information to be borne by and to accompany the instrument

(1)

A measuring instrument shall bear the following inscriptions

(a) manufacturer’s name, registered trade name or registered trade mark;

(b) information in respect of its accuracy; and, where applicable

(c) information in respect of the conditions of use;

(d) measuring capacity;

(e) measuring range;

(f) identity marking;

(g) number of the EU-type examination certificate or the EU design

examination certificate;

(h) information whether or not additional devices providing metrological

results comply with the provisions of these regulations on legal

metrological control.

(2)

An instrument of dimensions too small or of too sensitive a composition to

allow it to bear the relevant information shall have its packaging, if any, and

the accompanying documents required by the provisions of these regulations

suitably marked.

(3)

The instrument shall be accompanied by information on its operation, unless

the simplicity of the measuring instrument makes this unnecessary.

Information shall be easily understandable and shall include where relevant

(a) rated operating conditions;

(b) mechanical and electromagnetic environment classes;

(c) the upper and lower temperature limit, whether condensation is possible

or not, open or closed location;

(d) instructions for

installation,

maintenance,

repairs,

permissible

adjustments;

(e) instructions for correct operation and any special conditions of use;

(f) conditions for compatibility with interfaces, sub-assemblies or

measuring instruments.

(4)

Groups of identical measuring instruments used in the same location or used

for utility measurements do not necessarily require individual instruction

manuals.

(5)

Unless specified otherwise in an instrument-specific schedule, the scale

interval for a measured value shall be in the form 1 × 10n, 2 × 10n, or 5 ×

10n, where n is any integer or zero. The unit of measurement or its symbol

shall be shown close to the numerical value.

(6)

A material measure shall be marked with a nominal value or a scale,

accompanied by the unit of measurement used.

(7)

The units of measurement used and their symbols shall be in accordance with

the provisions of Union legislation on units of measurement and their

symbols.

(8)

All marks and inscriptions required under any requirement shall be clear,

non-erasable, unambiguous and non- transferable.

10. Indication of result

(1)

Indication of the result shall be by means of a display or hard copy.

(2)

The indication of any result shall be clear and unambiguous and accompanied

by such marks and inscriptions necessary to inform the user of the

significance of the result. Easy reading of the presented result shall be

permitted under normal conditions of use. Additional indications may be

shown provided they cannot be confused with the metrologically controlled

indications.

(3)

In the case of hard copy the print or record shall also be easily legible and

non-erasable.

(4)

A measuring instrument for direct sales trading transactions shall be designed

to present the measurement result to both parties in the transaction when

installed as intended. When critical in case of direct sales, any ticket provided

to the consumer by an ancillary device not complying with the appropriate

requirements of these regulations shall bear appropriate restrictive

information.

(5)

Whether or not a measuring instrument intended for utility measurement

purposes can be remotely read it shall in any case be fitted with a metrological

controlled display accessible without tools to the consumer. The reading of

this display is the measurement result that serves as the basis for the price to

pay.

11. Further processing of data to conclude the trading transaction

(1)

A measuring instrument other than a utility measuring instrument shall

record by a durable means the measurement result accompanied by

information to identify the particular transaction, when

(a) the measurement is non-repeatable; and

(b) the measuring instrument is normally intended for use in the absence of

one of the trading parties.

(2)

Additionally, a durable proof of the measurement result and the information

to identify the transaction shall be available on request at the time the

measurement is concluded.

12. Conformity evaluation

A measuring instrument shall be designed so as to allow ready evaluation of

its conformity with the appropriate requirements of these regulations

In these regulations, unless the context otherwise requires

Definitions.

"accreditation" means accreditation as defined in Article 2 of

Regulation (EC) no 765/2008;

"authorised representative" means any natural or legal person

established within the Union who has received a written mandate

from a manufacturer to act on his behalf in relation to specified tasks;

"Authority" means the Standards and Metrology Institute of the

Malta Competition and Consumer Affairs Authority;

"CE marking" means a marking by which the manufacturer

indicates that the measuring instrument is in conformity with the

applicable requirements set out in Union harmonisation legislation

providing for its affixing;

"conformity assessment" means the process demonstrating

whether the essential requirements of these regulations relating to a

measuring instrument have been fulfilled;

"conformity assessment body" means a body that performs

conformity assessment activities including calibration, testing,

certification and inspection.

"distributor" means any natural or legal person in the supply

chain, other than the manufacturer or the importer, who makes a

measuring instrument available on the market;

"economic operators" means the manufacturer, the authorised

representative, the importer and the distributor;

"harmonised standard" means harmonised standard as defined in

regulation 2 of Regulation (EU) No 1025/2012;

"importer" means any natural or legal person established within

the Union who places a measuring instrument from a third country on

the Union market;

"legal metrological control" means the control of the

measurement tasks intended for the field of application of a

measuring instrument, for reasons of public interest, public health,

public safety, public order, protection of the environment, levying of

taxes and duties, protection of the consumers and fair trading;

"making available on the market" means any supply of a

measuring instrument for distribution or use on the Union market in

the course of a commercial activity, whether in return for payment or

free of charge;

"manufacturer" means any natural or legal person who

manufactures a measuring instrument or has a measuring instrument

designed or manufactured, and markets that measuring instrument

under his name or trade mark or puts it into use for his own purposes;

"measuring instrument" means any device or system with a

measurement according to the provisions of these regulations;

"Member State" means a Member State of the European Union;

"Minister" means the Minister responsible for standards and

metrology and includes, to the extent of the authority given, any

person authorised by the Minister to act in that behalf for any purpose

of these regulations;

"National Accreditation Board (Malta)" means the National

Accreditation Board (Malta) established in terms of regulation 3 of

the National Accreditation Board (Malta) (Establishment) S.L. 419.07.

Regulations;

"normative document" means a document containing technical

specifications adopted by the International Organisation of Legal

Metrology * ;

"placing on the market" means the first making available of a

measuring instrument on the Union market;

"putting into use" means the first use of a measuring instrument

intended for the end-user for the purposes for which it was intended;

"recall" means any measure aimed at achieving the return of a

measuring instrument that has already been made available to the

end-user;

"sub-assembly" means a hardware device, mentioned as such in

the instrument-specific schedules that functions independently and

makes up a measuring instrument together with other sub-assemblies

with which it is compatible, or with a measuring instrument with

which it is compatible;

"technical specification" means a document that prescribes

technical requirements to be fulfilled by a measuring instrument;

"the Union" means the European Union as referred to article 2

of the European Union Act;

"Union harmonisation legislation" means any Union legislation

harmonising the conditions for the marketing of products; and

"withdrawal" means any measure aimed at preventing a

measuring instrument in the supply chain from being made available

on the market.

MODULE A: INTERNAL PRODUCTION CONTROL

1. ‘Internal production control’ is the conformity assessment procedure

whereby the manufacturer fulfils the obligations laid down in points 2, 3 and

4, and ensures and declares on his sole responsibility that the measuring

instruments concerned satisfy the requirements of these regulations that apply

to them.

2. Technical documentation

The manufacturer shall establish the technical documentation as described in

Regulation 18. The documentation shall make it possible to assess the

instrument’s conformity to the relevant requirements, and shall include an

adequate analysis and assessment of the risk(s). The technical documentation

shall specify the applicable requirements and cover, as far as relevant for the

assessment, the design, manufacture and operation of the instrument.

3. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing

process and its monitoring ensure compliance of the manufactured

instruments with the technical documentation referred to in point 2 and with

the requirements of these regulations that apply to them.

4. Conformity marking and EU declaration of conformity

(1)

The manufacturer shall affix the CE marking and the supplementary

metrology marking set out in these regulations to each individual measuring

instrument that satisfies the applicable requirements of these regulations.

(2)

The manufacturer shall draw up a written EU declaration of conformity for

an instrument model and keep it together with the technical documentation at

the disposal of the national authorities for 10 years after the measuring

instrument has been placed on the market. The EU declaration of conformity

shall identify the instrument for which it was drawn up.

A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request. A copy of the EU declaration of conformity

shall be supplied with each measuring instrument that is placed on the

market. However, this requirement may be interpreted as applying to a batch

or consignment rather than individual instruments in those cases where a

large number of instruments is delivered to a single user.

5. Authorised representative

The manufacturer’s obligations set out in point 4 may be fulfilled by his

authorised representative, on his behalf and under his responsibility, provided

that they are specified in the mandate.

MODULE A2: INTERNAL PRODUCTION CONTROL PLUS

SUPERVISED INSTRUMENT CHECKS AT RANDOM INTERVALS

Internal production control plus supervised instrument checks at random

intervals is the conformity assessment procedure whereby the manufacturer

fulfils the obligations laid down in points 2, 3, 4, and 5, and ensures and

declares on his sole responsibility that the measuring instruments concerned

satisfy the requirements of these regulations that apply to them.

2. Technical documentation

The manufacturer shall establish the technical documentation as described in

regulation 18. The documentation shall make it possible to assess the

instrument’s conformity with the relevant requirements, and shall include an

adequate analysis and assessment of the risk(s). The technical documentation

shall specify the applicable requirements and cover, as far as relevant for the

assessment, the design, manufacture and operation of the instrument.

3. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing

process and its monitoring ensure compliance of the manufactured

instruments with the technical documentation referred to in point 2 and with

the requirements of these regulations that apply to them.

4. Instrument checks

At the choice of the manufacturer, either an accredited in-house body or a

notified body, chosen by the manufacturer, shall carry out instrument checks

or have them carried out at random intervals determined by the body, in order

to verify the quality of the internal checks of the instrument, taking into

account, inter alia, the technological complexity of the instruments and the

quantity of production. An adequate sample of the final measuring

instruments, taken on site by the body before the placing on the market, shall

be examined and appropriate tests as identified by the relevant parts of the

harmonised standard, and/or normative document, and/or equivalent tests set

out in other relevant technical specifications, shall be carried out to verify the

conformity of the instruments with the relevant requirements of these

regulations. In the absence of a relevant harmonised standard or normative

document, the accredited in-house body or notified body concerned shall

decide on the appropriate tests to be carried out.

In those cases where a relevant number of instruments in the sample do not

conform to an acceptable quality level, the accredited in-house body or

notified body shall take appropriate measures.

Where the tests are carried out by a notified body, the manufacturer shall,

under the responsibility of the notified body, affix the notified body’s

identification number during the manufacturing process.

5. Conformity marking and EU declaration of conformity

(1)

The manufacturer shall affix the CE marking and the supplementary

metrology marking set out in these regulations to each individual instrument

that satisfies the applicable requirements of these regulations.

(2)

The manufacturer shall draw up a written EU declaration of conformity for

an instrument model and keep it together with the technical documentation at

the disposal of the national authorities for 10 years after the instrument has

been placed on the market. The EU declaration of conformity shall identify

the instrument for which it was drawn up.

A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request. A copy of the EU declaration of conformity

shall be supplied with each measuring instrument that is placed on the

market. However, this requirement may be interpreted as applying to a batch

or consignment rather than individual instruments in those cases where a

large number of instruments is delivered to a single user.

6. Authorised representative

The manufacturer’s obligations set out in point 5 may be fulfilled by his

authorised representative, on his behalf and under his responsibility provided

that they are specified in the mandate.

MODULE B: EU- TYPE EXAMINATION

1. ‘EU-type examination’ is the part of a conformity assessment procedure in

which a notified body examines the technical design of an instrument and

verifies and attests that the technical design of the instrument meets the

requirements of these regulations that apply to it.

2. EU-type examination may be carried out in either of the following manners

(a) examination of a specimen, representative of the production envisaged,

of the complete measuring instrument (production type),

(b) assessment of the adequacy of the technical design of the instrument

through examination of the technical documentation and supporting

evidence referred to in point 3, plus examination of specimens,

representative of the production envisaged, of one or more critical parts

of the instrument (combination of production type and design type);

(c) assessment of the adequacy of the technical design of the instrument

through examination of the technical documentation and supporting

evidence referred to in point 3, without examination of a specimen

(design type).

The notified body decides on the appropriate manner and the specimens

required.

3. The manufacturer shall lodge an application for EU-type examination with a

single notified body of his choice.

The application shall include

(a) the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as well;

(b) a written declaration that the same application has not been lodged with

any other notified body;

(c) the technical documentation as described in regulation 16. The technical

documentation shall make it possible to assess the instrument’s

conformity with the applicable requirements of these regulations and

shall include an adequate analysis and assessment of the risk(s). The

technical documentation shall specify the applicable requirements and

cover, as far as relevant for the assessment, the design, manufacture and

operation of the instrument.

The application shall in addition contain, wherever applicable

(d) the specimens, representative of the production envisaged. The notified

body may request further specimens if needed for carrying out the test

programme;

(e) the supporting evidence for the adequacy of the technical design

solution. This supporting evidence shall mention any documents that

have been used, in particular where the relevant harmonised standards,

and/or normative documents have not been applied in full. The

supporting evidence shall include, where necessary, the results of tests

carried out in accordance with other relevant technical specifications by

the appropriate laboratory of the manufacturer, or by another testing

laboratory on his behalf and under his responsibility.

4. The notified body shall: For the instrument

(1)

examine the technical documentation and supporting evidence to assess the

adequacy of the technical design of the instrument;

For the specimen(s)

(2)

verify that the specimen(s) have been manufactured in conformity with the

technical documentation and identify the elements which have been designed

in accordance with the applicable provisions of the relevant harmonised

standards and/or normative documents, as well as the elements which have

been designed in accordance with other relevant technical specifications;

(3)

carry out appropriate examinations and tests, or have them carried out, to

check whether, where the manufacturer has chosen to apply the solutions in

the relevant harmonised standards and normative documents, these have been

applied correctly;

(4)

carry out appropriate examinations and tests, or have them carried out, to

check whether, where the solutions in the relevant harmonised standards, and/

or normative documents have not been applied, the solutions adopted by the

manufacturer applying other relevant technical specifications meet the

corresponding essential requirements of these regulations

(5)

agree with the manufacturer on the location where the examinations and tests

will be carried out.

For the other parts of the measuring instrument

(6)

examine the technical documentation and supporting evidence to assess the

adequacy of the technical design of the other parts of the measuring

instrument.

5. The notified body shall draw up an evaluation report that records the

activities undertaken in accordance with point 4 and their outcomes. Without

prejudice to its obligations vis-à-vis, the notifying authorities, the notified

body shall release the content of that report, in full or in part, only with the

agreement of the manufacturer.

6. Where the type meets the requirements of these regulations, the notified body

shall issue an EU-type examination certificate to the manufacturer. That

certificate shall contain the name and address of the manufacturer, the

conclusions of the examination, the conditions (if any) for its validity and the

necessary data for identification of the approved type. The EU-type

examination certificate may have one or more schedules attached.

The EU-type examination certificate and its schedules shall contain all

relevant information to allow the conformity of manufactured measuring

instruments with the examined type to be evaluated and to allow for in-

service control. In particular, to allow the conformity of manufactured

instruments to be evaluated with the examined type regarding the

reproducibility of their metrological performances, when they are properly

adjusted using appropriate means, content shall include

-

the metrological characteristics of the type of instrument;

-

measures required for ensuring the integrity of the instruments

(sealing, identification of software, etc.);

-

information on other elements necessary for the identification of the

instruments and to check their visual external conformity to type;

-

if appropriate, any specific information necessary to verify the

characteristics of manufactured instruments;

-

in the case of a sub-assembly, all necessary information to ensure the

compatibility with other sub-assemblies or measuring instruments.

The EU-type examination certificate shall have a validity of 10 years from

the date of its issue, and may be renewed for subsequent periods of 10 years

each.

Where the type does not satisfy the applicable requirements of these

regulations, the notified body shall refuse to issue an EU-type examination

certificate and shall inform the applicant accordingly, giving detailed reasons

for its refusal.

7. The notified body shall keep itself apprised of any changes in the generally

acknowledged state of the art which indicate that the approved type may no

longer comply with the applicable requirements of these regulations, and

shall determine whether such changes require further investigation. If so, the

notified body shall inform the manufacturer accordingly.

8. The manufacturer shall inform the notified body that holds the technical

documentation relating to the EU-type examination certificate of all

modifications to the approved type that may affect the conformity of the

instrument with the essential requirements of these regulations or the

conditions for validity of that certificate Such modifications shall require

additional approval in the form of an addition to the original EU-type

examination certificate.

9. Each notified body shall inform the Authority concerning the EU-type

examination certificates and/or any additions thereto which it has issued or

withdrawn, and shall, periodically or upon request, make available to the

Authority the list of such certificates and/or any additions thereto refused,

suspended or otherwise restricted.

The Commission, the Member States and the other notified bodies may, on

request, obtain a copy of the EU-type examination certificates and/or

additions thereto. On request, the Commission and the Member States may

obtain a copy of the technical documentation and the results of the

examinations carried out by the notified body.

The notified body shall keep a copy of the EU-type examination certificate,

its schedules and additions, as well as the technical file including the

documentation submitted by the manufacturer until the expiry of the validity

of that certificate.

10. The manufacturer shall keep a copy of the EU-type examination certificate,

its schedules and additions together with the technical documentation at the

disposal of the national authorities for 10 years after the instrument has been

placed on the market.

11. The manufacturer’s authorised representative may lodge the application

referred to in point 3 and fulfil the obligations set out in points 8 and 10,

provided that they are specified in the mandate.

MODULE C: CONFORMITY TO TYPE BASED ON INTERNAL

PRODUCTION CONTROL

1. Conformity to type based on internal production control is the part of a

conformity assessment procedure whereby the manufacturer fulfils the

obligations laid down in points 2 and 3, and ensures and declares that the

measuring instruments concerned are in conformity with the type described in

the EU-type examination certificate and satisfy the requirements of these

regulations that apply to them.

2. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing

process and its monitoring ensure conformity of the manufactured measuring

instruments with the approved type described in the EU-type examination

certificate and with the requirements of these regulations that apply to them.

3. Conformity marking and EU declaration of conformity

(1)

The manufacturer shall affix the CE marking and the supplementary

metrology marking set out in these regulations to each individual instrument

that is in conformity with the type described in the EU-type examination

certificate and satisfies the applicable requirements of these regulations.

(2)

The manufacturer shall draw up a written EU declaration of conformity for

each instrument model and keep it at the disposal of the national authorities

for 10 years after the instrument has been placed on the market. The EU

declaration of conformity shall identify the instrument model for which it was

drawn up.

A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request. A copy of the EU declaration of conformity

shall be supplied with each measuring instrument that is placed on the

market. However, this requirement may be interpreted as applying to a batch

or consignment rather than individual instruments in those cases where a

large number of instruments is delivered to a single user.

4. Authorised representative

The manufacturer’s obligations set out in point 3 may be fulfilled by his

authorised representative, on his behalf and under his responsibility, provided

that they are specified in the mandate.

MODULE C2: CONFORMITY TO TYPE BASED ON INTERNAL

PRODUCTION CONTROL PLUS SUPERVISED INSTRUMENT

CHECKS AT RANDOM INTERVALS

1. Conformity to type based on internal production control plus supervised

instrument checks at random intervals is the part of a conformity assessment

procedure whereby the manufacturer fulfils the obligations laid down in

points 2, 3 and 4, and ensures and declares on his sole responsibility that the

measuring instruments concerned are in conformity with the type described in

the EU-type examination certificate and satisfy the requirements of these

regulations that apply to them.

2. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing

process and its monitoring ensure conformity of the manufactured measuring

instruments with the type described in the EU-type examination certificate

and with the requirements of these regulations that apply to them.

3. Instrument checks

At the choice of the manufacturer, either an accredited in-house body or a

notified body, chosen by the manufacturer, shall carry out instrument checks

or have them carried out at random intervals determined by the body, in order

to verify the quality of the internal checks on the instrument, taking into

account, inter alia, the technological complexity of the measuring instruments

and the quantity of production. An adequate sample of the final measuring

instrument, taken on site by the accredited in-house body or by the notified

body before the placing on the market, shall be examined and appropriate

tests, as identified by the relevant parts of the harmonised standards, and/or

normative documents, and/or equivalent tests set out in other relevant

technical specifications, shall be carried out to verify the conformity of the

instrument with the type described in the EU-type examination certificate and

with the relevant requirements of these regulations.

Where a sample does not conform to an acceptable quality level, the

accredited in-house body or notified body shall take appropriate measures.

The acceptance sampling procedure to be applied is intended to determine

whether the manufacturing process of the instrument performs within

acceptable limits, with a view to ensuring conformity of the instrument.

Where the tests are carried out by a notified body, the manufacturer shall,

under the responsibility of the notified body, affix the notified body’s

identification number during the manufacturing process.

4. Conformity marking and EU declaration of conformity

(1)

The manufacturer shall affix the CE marking, and the supplementary

metrology marking set out in these regulations to each individual measuring

instrument that is in conformity with the type described in the EU-type

examination certificate and satisfies the applicable requirements of these

regulations.

(2)

The manufacturer shall draw up a written EU declaration of conformity for

each instrument model and keep it at the disposal of the national authorities

for 10 years after the instrument has been placed on the market. The EU

declaration of conformity shall identify the instrument model for which it has

been drawn up.

A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request. A copy of the EU declaration of conformity

shall be supplied with each measuring instrument that is placed on the

market. However, this requirement may be interpreted as applying to a batch

or consignment rather than individual instruments in those cases where a

large number of instruments is delivered to a single user.

5. Authorised representative

The manufacturer’s obligations set out in point 4 may be fulfilled by his

authorised representative, on his behalf and under his responsibility, provided

that they are specified in the mandate.

MODULE D: CONFORMITY TO TYPE BASED ON QUALITY

ASSURANCE OF THE PRODUCTION PROCESS

1. Conformity to type based on quality assurance of the production process is

the part of a conformity assessment procedure whereby the manufacturer

fulfils the obligations laid down in points 2 and 5, and ensures and declares

on his sole responsibility that the measuring instruments concerned are in

conformity with the type described in the EU-type examination certificate

and satisfy the requirements of these regulations that apply to them.

2. Manufacturing

The manufacturer shall operate an approved quality system for production,

final product inspection and testing of the measuring instruments concerned

as specified in point 3 and shall be subject to surveillance as specified in point

4.

3. Quality system

(1)

The manufacturer shall lodge an application for assessment of his quality

system with a notified body of his choice, for the measuring instruments

concerned.

The application shall include

(a) the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as well,

(b) a written declaration that the same application has not been lodged with

any other notified body,

(c) all relevant information for the instrument category envisaged;

(d) the documentation concerning the quality system;

(e) the technical documentation of the approved type and a copy of the EU-

type examination certificate.

(2)

The quality system shall ensure that the measuring instruments are in

conformity with the type described in the EU- type examination certificate

and comply with the requirements of these regulations that apply to them.

All the elements, requirements and provisions adopted by the manufacturer

shall be documented in a systematic and orderly manner in the form of

written policies, procedures and instructions. This quality system

documentation shall permit a consistent interpretation of the quality

programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of

(a) the quality objectives and the organisational structure, responsibilities

and powers of the management with regard to product quality;

(b) the corresponding manufacturing, quality control and quality assurance

techniques, processes and systematic actions that will be used;

(c) the examinations and tests that will be carried out before, during, and

after manufacture, and the frequency with which they will be carried out;

(d) the quality records, such as inspection reports and test data, calibration

data, qualification reports on the personnel concerned;

(e) the means of monitoring the achievement of the required product quality

and the effective operation of the quality system.

(3)

The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in point 3.2.

It shall presume conformity with those requirements in respect of the

elements of the quality system that comply with the corresponding

specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team

shall have at least one member with experience of evaluation in the relevant

instrument field and instrument technology concerned, and knowledge of the

applicable requirements of these regulations. The audit shall include an

assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to in

point (e) of point 3.1, to verify the manufacturer’s ability to identify the

relevant requirements of these regulations and to carry out the necessary

examinations with a view to ensuring compliance of the instrument with

those requirements.

The decision shall be notified to the manufacturer. The notification shall

contain the conclusions of the audit and the reasoned assessment decision.

(4)

The manufacturer shall undertake to fulfil the obligations arising out of the

quality system as approved and to maintain it so that it remains adequate and

efficient.

(5)

The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change of the quality system.

The notified body shall evaluate any proposed changes and decide whether

the modified quality system will continue to satisfy the requirements referred

to in point 3.2 or whether a re-assessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain

the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

(1)

The purpose of surveillance is to make sure that the manufacturer duly fulfils

the obligations arising out of the approved quality system.

(2)

The manufacturer shall, for assessment purposes, allow the notified body

access to the manufacture, inspection, testing and storage sites, and shall

provide it with all necessary information, in particular

(a) the quality system documentation;

(b) the quality records, such as inspection reports and test data, calibration

data, qualification reports on the personnel concerned.

(3)

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and shall provide the

manufacturer with an audit report.

(4)

In addition, the notified body may pay unexpected visits to the manufacturer.

During such visits the notified body may, if necessary, carry out instrument

tests, or have them carried out, in order to verify that the quality system is

functioning correctly. The notified body shall provide the manufacturer with

a visit report and, if tests have been carried out, with a test report.

5. Conformity marking and EU declaration of conformity

(1)

The manufacturer shall affix the CE marking and the supplementary

metrology marking set out in these regulations, and, under the responsibility

of the notified body referred to in point 3.1, the latter’s identification number

to each individual measuring instrument that is in conformity with the type

described in the EU-type examination certificate and satisfies the applicable

requirements of these regulations.

(2)

The manufacturer shall draw up a written EU declaration of conformity for

each instrument model and keep it at the disposal of the national authorities

for 10 years after the instrument has been placed on the market. The EU

declaration of conformity shall identify the instrument model for which it has

been drawn up.

A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request. A copy of the EU declaration of conformity

shall be supplied with each measuring instrument that is placed on the

market. However, this requirement may be interpreted as applying to a batch

or consignment rather than individual instruments in those cases where a

large number of instruments are delivered to a single user.

6. The manufacturer shall, for a period ending 10 years after the instrument has

been placed on the market, keep at the disposal of the national authorities

(a) the documentation referred to in point 3.1,

(b) the information relating to the change referred to in point 3.5, as

approved;

(c) the decisions and reports from the notified body referred to in points 3.5,

4.3 and 4.4.

7. Each notified body shall inform the Authority of quality system approvals

issued or withdrawn, and shall, periodically or upon request, make available

to the Authority the list of quality system approvals refused, suspended or

otherwise restricted.

8. Authorised representative

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be

fulfilled by his authorised representative, on his behalf and under his

responsibility, provided that they are specified in the mandate.

MODULE D1: QUALITY ASSURANCE OF THE PRODUCTION

PROCESS

1. Quality assurance of the production process is the conformity assessment

procedure whereby the manufacturer fulfils the obligations laid down in

points 2, 4 and 7, and ensures and declares on his sole responsibility that the

measuring instruments concerned satisfy the requirements of these

regulations that apply to them.

2. Technical documentation

The manufacturer shall establish the technical documentation as described in

regulation 18. The documentation shall make it possible to assess the

instrument’s conformity with the relevant requirements, and shall include an

adequate analysis and assessment of the risk(s). The technical documentation

shall specify the applicable requirements and cover, as far as relevant for the

assessment, the design, manufacture and operation of the instrument.

3. The manufacturer shall keep the technical documentation at the disposal of

the national authorities for 10 years after the instrument has been placed on

the market.

4. Manufacturing

The manufacturer shall operate an approved quality system for production,

final product inspection and testing of the measuring instruments concerned

as specified in point 5 and shall be subject to surveillance as specified in point

6.

5. Quality system

(1)

The manufacturer shall lodge an application for assessment of his quality

system with a notified body of his choice, for the measuring instruments

concerned.

The application shall include

(a) the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as well;

(b) a written declaration that the same application has not been lodged with

any other notified body;

(c) all relevant information for the instrument category envisaged;

(d) the documentation concerning the quality system;

(e) the technical documentation referred to in point 2.

(2)

The quality system shall ensure compliance of the measuring instruments

with the requirements of these regulations that apply to them.

All the elements, requirements and provisions adopted by the manufacturer

shall be documented in a systematic and orderly manner in the form of

written policies, procedures and instructions. This quality system

documentation shall permit a consistent interpretation of the quality

programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of

(a) the quality objectives and the organisational structure, responsibilities

and powers of the management with regard to product quality;

(b) the corresponding manufacturing, quality control and quality assurance

techniques, processes and systematic actions that will be used;

(c) the examinations and tests that will be carried out before, during, and

after manufacture, and the frequency with which they will be carried out;

(d) the quality records, such as inspection reports and test data, calibration

data, qualification reports on the personnel concerned;

(e) the means of monitoring the achievement of the required product quality

and the effective operation of the quality system.

(3)

The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in point 5.2.

It shall presume conformity with those requirements in respect of the

elements of the quality system that comply with the corresponding

specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team

shall have at least one member with experience of evaluation in the relevant

instrument field and instrument technology concerned, and knowledge of the

applicable requirements of these regulations. The audit shall include an

assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to in

point 2 in order to verify the manufacturer’s ability to identify the relevant

requirements of these regulations and to carry out the necessary examinations

with a view to ensuring compliance of the instrument with those

requirements.

The decision shall be notified to the manufacturer. The notification shall

contain the conclusions of the audit and the reasoned assessment decision.

(4)

The manufacturer shall undertake to fulfil the obligations arising out of the

quality system as approved and to maintain it so that it remains adequate and

efficient.

(5)

The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change of the quality system.

The notified body shall evaluate any proposed changes and decide whether

the modified quality system will continue to satisfy the requirements referred

to in point 5.2 or whether are assessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain

the conclusions of the examination and the reasoned assessment decision.

6. Surveillance under the responsibility of the notified body

(1)

The purpose of surveillance is to make sure that the manufacturer duly fulfils

the obligations arising out of the approved quality system.

(2)

The manufacturer shall, for assessment purposes, allow the notified body

access to the manufacture, inspection, testing and storage sites, and shall

provide it with all necessary information, in particular

(a) the quality system documentation;

(b) the technical documentation referred to in point 2;

(c) the quality records, such as inspection reports and test data, calibration

data, qualification reports on the personnel concerned.

(3)

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and shall provide the

manufacturer with an audit report.

(4)

In addition, the notified body may pay unexpected visits to the manufacturer.

During such visits the notified body may, if necessary, carry out instrument

tests, or have them carried out, in order to verify that the quality system is

functioning correctly. The notified body shall provide the manufacturer with

a visit report and, if tests have been carried out, with a test report.

7. Conformity marking and EU declaration of conformity

(1)

The manufacturer shall affix the CE marking, the supplementary metrology

marking set out in these regulations, and, under the responsibility of the

notified body referred to in point 5.1, the latter’s identification number to

each individual measuring instrument that satisfies the applicable

requirements of these regulations.

(2)

The manufacturer shall draw up a written EU declaration of conformity for

each instrument model and keep it at the disposal of the national authorities

for 10 years after the instrument has been placed on the market. The EU

declaration of conformity shall identify the instrument model for which it has

been drawn up.

A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request.

A copy of the EU declaration of conformity shall be supplied with each

measuring instrument that is placed on the market. However, this requirement

may be interpreted as applying to a batch or consignment rather than

individual instruments in those cases where a large number of instruments is

delivered to a single user.

8. The manufacturer shall, for a period ending 10 years after the instrument has

been placed on the market, keep at the disposal of the national authorities

(a) the documentation referred to in point 5.1;

(b) the information relating to the change referred to in point 5.5, as

approved;

(c) the decisions and reports of the notified body referred to in points 5.5,

6.3 and 6.4.

9. Each notified body shall inform the Authority of quality system approvals

issued or withdrawn, and shall, periodically or upon request, make available

to the Authority the list of quality system approvals refused, suspended or

otherwise restricted.

10. Authorised representative

The manufacturer’s obligations set out in points 3, 5.1, 5.5, 7 and 8 may be

fulfilled by his authorised representative, on his behalf and under his

responsibility, provided that they are specified in the mandate.

MODULE E: CONFORMITY TO TYPE BASED ON INSTRUMENT

QUALITY ASSURANCE

1. Conformity to type based on instrument quality assurance is that part of a

conformity assessment procedure whereby the manufacturer fulfils the

obligations laid down in points 2 and 5, and ensures and declares on his sole

responsibility that the measuring instruments concerned are in conformity

with the type described in the EU-type examination certificate and satisfy the

requirements of these regulations that apply to them.

2. Manufacturing

The manufacturer shall operate an approved quality system for final product

inspection and testing of the measuring instruments concerned as specified in

point 3 and shall be subject to surveillance, as specified in point 4.

3. Quality system

(1)

The manufacturer shall lodge an application for assessment of his quality

system with a notified body of his choice, for the measuring instruments

concerned.

The application shall include

(a) the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as well;

(b) a written declaration that the same application has not been lodged with

any other notified body;

(c) all relevant information for the instrument category envisaged;

(d) the documentation concerning the quality system;

(e) the technical documentation of the approved type and a copy of the EU-

type examination certificate.

(2)

The quality system shall ensure compliance of the measuring instruments

with the type described in the EU-type examination certificate and with the

applicable requirements of these regulations.

All the elements, requirements and provisions adopted by the manufacturer

shall be documented in a systematic and orderly manner in the form of

written policies, procedures and instructions. This quality system

documentation shall permit a consistent interpretation of the quality

programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of

(a) the quality objectives and the organisational structure, responsibilities

and powers of the management with regard to product quality;

(b) the examinations and tests that will be carried out after manufacture;

(c) the quality records, such as inspection reports and test data, calibration

data, qualification reports on the personnel concerned;

(d) the means of monitoring the effective operation of the quality system.

(3)

The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in point 3.2.

It shall presume conformity with those requirements in respect of the

elements of the quality system that comply with the corresponding

specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team

shall have at least one member with experience of evaluation in the relevant

instrument field and instrument technology concerned, and knowledge of the

applicable requirements of these regulations. The audit shall include an

assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to in

point (e) of point 3.1, in order to verify the manufacturer’s ability to identify

the relevant requirements of these regulations and to carry out the necessary

examinations with a view to ensuring compliance of the instrument with

those requirements.

The decision shall be notified to the manufacturer. The notification shall

contain the conclusions of audit and the reasoned assessment decision.

(4)

The manufacturer shall undertake to fulfil the obligations arising out of the

quality system as approved and to maintain it so that it remains adequate and

efficient.

(5)

The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether

the modified quality system will continue to satisfy the requirements referred

to in point 3.2 or whether a re-assessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain

the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

(1)

The purpose of surveillance is to make sure that the manufacturer duly fulfils

the obligations arising out of the approved quality system.

(2)

The manufacturer shall, for assessment purposes, allow the notified body

access to the manufacture, inspection, testing and storage sites, and shall

provide it with all necessary information, in particular

(a) the quality system documentation;

(b) the quality records, such as inspection reports and test data, calibration

data, qualification reports on the personnel concerned.

(3)

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and shall provide the

manufacturer with an audit report.

(4)

In addition, the notified body may pay unexpected visits to the manufacturer.

During such visits the notified body may, if necessary, carry out instrument

tests, or have them carried out, in order to verify that the quality system is

functioning correctly. The notified body shall provide the manufacturer with

a visit report and, if tests have been carried out, with a test report.

5. Conformity marking and EU declaration of conformity

(1)

The manufacturer shall affix the CE marking, the supplementary metrology

marking set out in these regulations, and, under the responsibility of the

notified body referred to in point 3.1, the latter’s identification number to

each individual instrument that is in conformity with the type described in the

EU-type examination certificate and satisfies the applicable requirements of

these regulations.

(2)

The manufacturer shall draw up a written EU declaration of conformity for

each instrument model and keep it at the disposal of the national authorities

for 10 years after the instrument has been placed on the market. The EU

declaration of conformity shall identify the instrument model for which it has

been drawn up.

A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request. A copy of the EU declaration of conformity

shall be supplied with each measuring instrument that is placed on the

market. However, this requirement may be interpreted as applying to a batch

or consignment rather than individual instruments in those cases where a

large number of instruments are delivered to a single user.

6. The manufacturer shall, for a period ending 10 years after the instrument has

been placed on the market, keep at the disposal of the national authorities

(a) the documentation referred to in point 3.1;

(b) the information relating to the change referred to in point 3.5, as

approved;

(c) the decisions and reports of the notified body referred to in points 3.5,

4.3 and 4.4.

7. Each notified body shall inform the Authority of quality system approvals

issued or withdrawn, and shall, periodically or upon request, make available

to the Authority the list of quality system approvals refused, suspended or

otherwise restricted.

8. Authorised representative

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be

fulfilled by his authorised representative, on his behalf and under his

responsibility, provided that they are specified in the mandate.

MODULE E1: QUALITY ASSURANCE OF FINAL INSTRUMENT

INSPECTION AND TESTING

1. Quality assurance of final instrument inspection and testing is the conformity

assessment procedure whereby the manufacturer fulfils the obligations laid

down in points 2, 4 and 7, and ensures and declares on his sole responsibility

that the measuring instruments concerned satisfy the requirements of these

regulations that apply to them.

2. Technical documentation

The manufacturer shall establish the technical documentation as described in

regulation 18. The documentation shall make it possible to assess the

instrument’s conformity with the relevant requirements, and shall include an

adequate analysis and assessment of the risk(s). The technical documentation

shall specify the applicable requirements and cover, as far as relevant for the

assessment, the design, manufacture and operation of the instrument.

3. The manufacturer shall keep the technical documentation at the disposal of

the relevant national authorities for 10 years after the instrument has been

placed on the market.

4. Manufacturing

The manufacturer shall operate an approved quality system for final product

inspection and testing of the measuring instruments concerned as specified in

point 5 and shall be subject to surveillance as specified in point 6.

5. Quality system

5(1) The manufacturer shall lodge an application for assessment of his quality

system with the notified body of his choice, for the measuring instruments

concerned.

The application shall include

(a) the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as well;

(b) a written declaration that the same application has not been lodged with

any other notified body;

(c) all relevant information for the instrument category envisaged;

(d) the documentation concerning the quality system;

(e) the technical documentation referred to in point 2.

(2)

The quality system shall ensure compliance of the measuring instruments

with the requirements of these regulations that apply to them.

All the elements, requirements and provisions adopted by the manufacturer

shall be documented in a systematic and orderly manner in the form of

written policies, procedures and instructions. The quality system

documentation shall permit a consistent interpretation of the quality

programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of

(a) the quality objectives and the organisational structure, responsibilities

and powers of the management with regard to product quality;

(b) the examinations and tests that will be carried out after manufacture;

(c) the quality records, such as inspection reports and test data, calibration

data, qualification reports on the personnel concerned;

(d) the means of monitoring the effective operation of the quality system.

(3)

The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in point 5.2.

It shall presume conformity with those requirements in respect of the

elements of the quality system that comply with the corresponding

specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team

shall have at least one member with experience of evaluation in the relevant

instrument field and instrument technology concerned, and knowledge of the

applicable requirements of these regulations. The audit shall include an

assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to in

point 2 in order to verify the manufacturer’s ability to identify the relevant

requirements of these regulations and to carry out the necessary examinations

with a view to ensuring compliance of the instrument with those

requirements.

The decision shall be notified to the manufacturer. The notification shall

contain the conclusions of the audit and the reasoned assessment decision.

(4)

The manufacturer shall undertake to fulfil the obligations arising out of the

quality system as approved and to maintain it so that it remains adequate and

efficient.

(5)

The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether

the modified quality system will continue to satisfy the requirements referred

to in point 5.2 or whether a re-assessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain

the conclusions of the examination and the reasoned assessment decision.

6. Surveillance under the responsibility of the notified body

(1)

The purpose of surveillance is to make sure that the manufacturer duly fulfils

the obligations arising out of the approved quality system.

(2)

The manufacturer shall, for assessment purposes, allow the notified body

access to the manufacture, inspection, testing and storage sites, and shall

provide it with all necessary information, in particular

(a) the quality system documentation;

(b) the technical documentation referred to in point 2;

(c) the quality records, such as inspection reports and test data, calibration

data, qualification reports on the personnel concerned.

(3)

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and shall provide the

manufacturer with an audit report.

(4) In addition, the notified body may pay unexpected visits to the manufacturer.

During such visits the notified body may, if necessary, carry out instrument

tests, or have them carried out, in order to verify that the quality system is

functioning correctly. The notified body shall provide the manufacturer with

a visit report and, if tests have been carried out, with a test report.

7. Conformity marking and EU declaration of conformity

(1)

The manufacturer shall affix the CE marking, the supplementary metrology

marking set out in these regulations, and, under the responsibility of the

notified body referred to in point 5.1, the latter’s identification number to

each individual measuring instrument that satisfies the applicable

requirements of these regulations.

(2)

The manufacturer shall draw up a written EU declaration of conformity for

each instrument model and keep it at the disposal of the national authorities

for 10 years after the instrument has been placed on the market. The EU

declaration of conformity shall identify the instrument model for which it has

been drawn up.

A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request. A copy of the EU declaration of conformity

shall be supplied with each measuring instrument that is placed on the

market.

However, this requirement may be interpreted as applying to a batch or

consignment rather than individual instruments in those cases where a large

number of instruments is delivered to a single user.

8. The manufacturer shall, for a period ending 10 years after the instrument has

been placed on the market, keep at the disposal of the national authorities

(a) the documentation referred to in point 5.1,

(b) the information relating to the change referred to in point 5.5, as

approved;

(c) the decisions and reports from the notified body referred to in points 5.5,

6.3 and 6.4.

9. Each notified body shall inform the Authority of quality system approvals

issued or withdrawn, and shall, periodically or upon request, make available

to the Authority the list of quality system approvals refused, suspended or

otherwise restricted.

10. Authorised representative

The manufacturer’s obligations set out in points 3, 5.1, 5.5, 7 and 8 may be

fulfilled his authorised representative, on his behalf and under his

responsibility, provided that they are specified in the mandate.

MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT

VERIFICATION

1. Conformity to type based on product verification is the part of a conformity

assessment procedure whereby the manufacturer fulfils the obligations laid

down in points 2, 5.1 and 6, and ensures and declares on his sole

responsibility that the measuring instruments concerned, which have been

subject to the provisions of point 3, are in conformity with the type described

in the EU-type examination certificate and satisfy the requirements of these

regulations that apply to them.

2. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing

process and its monitoring ensure conformity of the manufactured measuring

instruments with the approved type described in the EU-type examination

certificate and with the requirements of these regulations that apply to them.

3. Verification

A notified body chosen by the manufacturer shall carry out the appropriate

examinations and tests, or have them carried out, to verify the conformity of

the instruments with the type as described in the EU-type examination

certificate and the appropriate requirements of these regulations.

The examinations and tests to verify the conformity of the measuring

instruments with the appropriate requirements shall be carried out, at the

choice of the manufacturer, either by examination and testing of every

instrument as specified in point 4, or by examination and testing of the

measuring instruments on a statistical basis as specified in point 5.

4. Verification of conformity by examination and testing of every instrument

(1)

All measuring instruments shall be individually examined and appropriate

tests set out in the relevant harmonised standard(s) and/or normative

documents, and/or equivalent tests set out in other relevant technical

specifications, shall be carried out in order to verify their conformity with the

approved type described in the EU-type examination certificate and with the

appropriate requirements of these regulations.

In the absence of a harmonised standard or normative document, the notified

body concerned shall decide on the appropriate tests to be carried out.

(2)

The notified body shall issue a certificate of conformity in respect of the

examinations and tests carried out, and shall affix its identification number to

each approved instrument or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity available for

inspection by the national authorities for 10 years after the instrument has

been placed on the market.

5. Statistical verification of conformity

(1)

The manufacturer shall take all measures necessary so that the manufacturing

process and its monitoring ensure the homogeneity of each lot produced, and

shall present his measuring instruments for verification in the form of

homogeneous lots.

(2)

A random sample shall be taken from each lot according to the requirements

of point 5.3. All measuring instruments in a sample shall be individually

examined and appropriate tests set out in the relevant harmonised standard(s)

and/or normative document(s), and/or equivalent tests set out in other

relevant technical specifications, shall be carried out in order to verify their

conformity with the type described in the EU-type examination certificate

and with the applicable requirements of these regulations, and to determine

whether the lot is accepted or rejected. In the absence of such harmonised

standard or normative document, the notified body concerned shall decide on

the appropriate tests to be carried out.

(3)

The statistical procedure shall meet the following requirements

The statistical control will be based on attributes. The sampling system shall

ensure

(a) a level of quality corresponding to a probability of acceptance of 95%,

with a non-conformity of less than 1%;

(b) a limit quality corresponding to a probability of acceptance of 5%, with a

non-conformity of less than 7%.

(4)

If a lot is accepted, all measuring instruments of the lot shall be considered

approved, except for those measuring instruments from the sample that have

been found not to satisfy the tests.

The notified body shall issue a certificate of conformity in respect of the

examinations and tests carried out, and shall affix its identification number to

each approved instrument or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity at the disposal of

the national authorities for 10 years after the instrument has been placed on

the market.

(5)

If a lot is rejected, the notified body shall take appropriate measures to

prevent the placing on the market of that lot.

In the event of frequent rejection of lots the notified body may suspend the

statistical verification and take appropriate measures.

6. Conformity marking and EU declaration of conformity

(1)

The manufacturer shall affix the CE marking and the supplementary

metrology marking set out in these regulations, and, under the responsibility

of the notified body referred to in point 3, the latter’s identification number to

each individual instrument that is in conformity with the approved type

described in the EU-type examination certificate and satisfies the applicable

requirements of these regulations.

(2)

The manufacturer shall draw up a written EU declaration of conformity for

each instrument model and keep it at the disposal of the national authorities

for 10 years after the instrument has been placed on the market. The EU

declaration of conformity shall identify the instrument model for which it has

been drawn up.

A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request. A copy of the EU declaration of conformity

shall be supplied with each measuring instrument that is placed on the

market. However, this requirement may be interpreted as applying to a batch

or consignment rather than individual instruments in those cases where a

large number of instruments is delivered to a single user.

If the notified body referred to in point 3 agrees and under its responsibility,

the manufacturer may also affix the notified body’s identification number to

the measuring instruments.

7. If the notified body agrees and under its responsibility, the manufacturer may

affix the notified body’s identification number to the measuring instruments

during the manufacturing process.

8. Authorised representative

The manufacturer’s obligations may be fulfilled by his authorised

representative, on his behalf and under his responsibility, provided that they

are specified in the mandate. An authorised representative may not fulfil the

manufacturer’s obligations set out in points 2 and 5.1.

MODULE F1: CONFORMITY BASED ON PRODUCT VERIFICATION

1. Conformity based on product verification is the conformity assessment

procedure whereby the manufacturer fulfils the obligations laid down in

points 2, 3, 6.1 and 7 and ensures and declares on his sole responsibility that

the measuring instruments concerned which have been subject to the

provisions of point 4, are in conformity with the requirements of these

regulations that apply to them.

2. Technical documentation

The manufacturer shall establish the technical documentation as described in

regulation 18. The documentation shall make it possible to assess the

instrument’s conformity with the relevant requirements, and shall include an

adequate analysis and assessment of the risk(s). The technical documentation

shall specify the applicable requirements and cover, as far as relevant for the

assessment, the design, manufacture and operation of the instrument.

The manufacturer shall keep the technical documentation at the disposal of

the relevant national authorities for 10 years after the instrument has been

placed on the market.

3. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing

process and its monitoring ensure conformity of the manufactured measuring

instruments with the applicable requirements of these regulations.

4. Verification

A notified body chosen by the manufacturer shall carry out the appropriate

examinations and tests, or have them carried out, to verify the conformity of

the measuring instruments with the applicable requirements of these

regulations.

The examinations and tests to verify the conformity with the requirements

shall be carried out, at the choice of the manufacturer, either by examination

and testing of every instrument as specified in point 5, or by examination and

testing of the measuring instruments on a statistical basis as specified in point

6.

5. Verification of conformity by examination and testing of every instrument

(1)

All measuring instruments shall be individually examined and appropriate

tests, set out in the relevant harmonized standards and/or normative

documents, and/or equivalent tests set out in other relevant technical

specifications, shall be carried out to verify their conformity with the

requirements that apply to them. In the absence of such a harmonised

standard, or normative document, the notified body concerned shall decide on

the appropriate tests to be carried out.

(2)

The notified body shall issue a certificate of conformity in respect of the

examinations and tests carried out, and shall affix its identification number to

each approved instrument or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity at the disposal of

the national authorities for 10 years after the instrument has been placed on

the market.

6. Statistical verification of conformity

(1)

The manufacturer shall take all measures necessary so that the manufacturing

process ensures the homogeneity of each lot produced, and shall present his

measuring instruments for verification in the form of homogeneous lots.

(2)

A random sample shall be taken from each lot according to the requirements

of point 6.4.

(3)

All measuring instruments in the sample shall be individually examined and

appropriate tests set out in the relevant harmonised standards and/or

normative documents, and/or equivalent tests set out in other relevant

technical specifications, shall be carried out in order to verify their

conformity with the applicable requirements of these regulations and to

determine whether the lot is accepted or rejected. In the absence of such

harmonised standard, or normative document, the notified body concerned

shall decide on the appropriate tests to be carried out.

(4)

The statistical procedure shall meet the following requirements

The statistical control will be based on attributes. The sampling system shall

ensure

(a) a level of quality corresponding to a probability of acceptance of 95%,

with a non-conformity of less than 1%; (b) a limit quality corresponding

to a probability of acceptance of 5%, with a non-conformity of less than

7%.

(5)

If a lot is accepted, all measuring instruments of the lot shall be considered

approved, except for those measuring instruments from the sample that have

been found not to satisfy the tests.

The notified body shall issue a certificate of conformity in respect of the

examinations and tests carried out, and shall affix its identification number to

each approved instrument or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity at the disposal of

the national authorities for 10 years after the instrument has been placed on

the market.

If a lot is rejected, the notified body shall take appropriate measures to

prevent that lot from being placed on the market. In the event of frequent

rejection of lots the notified body may suspend the statistical verification and

take appropriate measures.

7. Conformity marking and EU declaration of conformity

(1)

The manufacturer shall affix the CE marking and the supplementary

metrology marking set out in these regulations, and under the responsibility

of the notified body referred to in point 4, the latter’s identification number to

each individual measuring instrument that satisfies the applicable

requirements of these regulations.

(2)

The manufacturer shall draw up a written EU declaration of conformity for

each instrument model and keep it at the disposal of the national authorities

for 10 years after the instrument has been placed on the market. The EU

declaration of conformity shall identify the instrument model for which it has

been drawn up.

A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request. A copy of the EU declaration of conformity

shall be supplied with each measuring instrument that is placed on the

market. However, this requirement may be interpreted as applying to a batch

or consignment rather than individual measuring instruments in those cases

where a large number of instruments is delivered to a single user.

If the notified body referred to in point 5 agrees and under its responsibility,

the manufacturer may also affix the notified body’s identification number to

the measuring instruments.

8. If the notified body agrees and under its responsibility, the manufacturer may

affix the notified body’s identification number to the measuring instruments

during the manufacturing process.

9. Authorised representative

The manufacturer’s obligations may be fulfilled by his authorised

representative, on his behalf and under his responsibility, provided that they

are specified in the mandate. An authorised representative may not fulfil the

manufacturer’s obligations set out in point 2, first paragraph, point 3 and

point 6.1.

MODULE G: CONFORMITY BASED ON UNIT VERIFICATION

1. Conformity based on unit verification is the conformity assessment

procedure whereby the manufacturer fulfils the obligations laid down in

points 2, 3 and 5 and ensures and declares on his sole responsibility that the

instrument concerned, which has been subject to the provisions of point 4, is

in conformity with the requirements of these regulation that apply to it.

2. Technical documentation

The manufacturer shall establish the technical documentation as described in

regulation 18 and make it available to the notified body referred to in point 4.

The documentation shall make it possible to assess the instrument’s

conformity with the relevant requirements, and shall include an adequate

analysis and assessment of the risk(s). The technical documentation shall

specify the applicable requirements and cover, as far as relevant for the

assessment, the design, manufacture and operation of the instrument.

The manufacturer shall keep the technical documentation at the disposal of

the relevant national authorities for 10 years after the instrument has been

placed on the market.

3. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing

process and its monitoring ensure conformity of the manufactured instrument

with the applicable requirements of these regulations.

4. Verification

A notified body chosen by the manufacturer shall carry out the appropriate

examinations and tests set out in the relevant harmonised standards, and/or

normative documents or equivalent tests set out in other relevant technical

specifications, to verify the conformity of the instrument with the applicable

requirements of these regulations, or have them carried out. In the absence of

such a harmonised standard, or normative document, the notified body

concerned shall decide on the appropriate tests to be carried out.

The notified body shall issue a certificate of conformity in respect of the

examinations and tests carried out and affix its identification number to the

approved instrument, or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity at the disposal of

the national authorities for 10 years after the instrument has been placed on

the market.

5. Conformity marking and EU declaration of conformity

(1)

The manufacturer shall affix the CE marking and the supplementary

metrology marking set out in these regulations and, under the responsibility

of the notified body referred to in point 4, the latter’s identification number to

each instrument that satisfies the applicable requirements of these

regulations.

5.2. The manufacturer shall draw up a written EU declaration of conformity and

keep it at the disposal of the national authorities for 10 years after the

instrument has been placed on the market. The EU declaration of conformity

shall identify the instrument for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request. A copy of the EU declaration of conformity

shall be supplied with the measuring instrument.

6. Authorised representative

The manufacturer’s obligations set out in points 2 and 5 may be fulfilled by

his authorised representative, on his behalf and under his responsibility,

provided that they are specified in the mandate.

MODULE H

CONFORMITY

BASED

ON

FULL

QUALITY

ASSURANCE

1. Conformity based on full quality assurance is the conformity assessment

procedure whereby the manufacturer fulfils the obligations laid down in

points 2 and 5, and ensures and declares on his sole responsibility that the

measuring instruments concerned satisfy the requirements of these

regulations that apply to them.

2. Manufacturing

The manufacturer shall operate an approved quality system for design,

manufacture and final product inspection and testing of the measuring

instruments concerned as specified in point 3, and shall be subject to

surveillance as specified in point 4.

3. Quality system

(1)

The manufacturer shall lodge an application for assessment of his quality

system with the notified body of his choice, for the measuring instruments

concerned.

The application shall include

(a) the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as well,

(b) the technical documentation, as described in regulation 18, for one model

of each category of measuring instruments intended to be manufactured.

The documentation shall make it possible to assess the instrument’s

conformity with the relevant requirements, and shall include an adequate

analysis and assessment of the risk(s). The technical documentation shall

specify the applicable requirements and cover, as far as relevant for the

assessment, the design, manufacture and operation of the instrument,

(c) the documentation concerning the quality system, and

(d) a written declaration that the same application has not been lodged with

any other notified body.

(2)

The quality system shall ensure compliance of the measuring instruments

with the requirements of these regulations that apply to them.

All the elements, requirements and provisions adopted by the manufacturer

shall be documented in a systematic and orderly manner in the form of

written policies, procedures and instructions. This quality system

documentation shall permit a consistent interpretation of the quality

programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of

(a) the quality objectives and the organisational structure, responsibilities

and powers of the management with regard to design and product

quality;

(b) the technical design specifications, including standards, that will be

applied and, where the relevant harmonised standards, and/or normative

documents will not be applied in full, the means that will be used to

ensure that the essential requirements of these regulations that apply to

the measuring instruments will be met applying other relevant technical

specifications;

(c) the design control and design verification techniques, processes and

systematic actions that will be used when designing the measuring

instruments pertaining to the instrument category covered;

(d) the corresponding manufacturing, quality control and quality assurance

techniques, processes and systematic actions that will be used;

(e) the examinations and tests that will be carried out before, during and

after manufacture, and the frequency with which they will be carried out;

(f) the quality records, such as inspection reports and test data, calibration

data, qualification reports on the personnel concerned;

(g) the means of monitoring the achievement of the required design and

product quality and the effective operation of the quality system.

(3)

The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in point 3.2.

It shall presume conformity with those requirements in respect of the

elements of the quality system that comply with the corresponding

specifications of the relevant harmonised standard.

In addition to experience in quality management systems, the auditing team

shall have at least one member experienced as an assessor in the relevant

instrument field and instrument technology concerned, and knowledge of the

applicable requirements of these regulations. The audit shall include an

assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to in

point (b) of point 3.1 to verify the manufacturer’s ability to identify the

applicable requirements of these regulations and to carry out the necessary

examinations with a view to ensuring compliance of the instrument with

those requirements.

The manufacturer or his authorised representative shall be notified of the

decision. The notification shall contain the conclusions of the audit and the

reasoned assessment decision.

(4)

The manufacturer shall undertake to fulfil the obligations arising out of the

quality system as approved and to maintain it so that it remains adequate and

efficient.

(5)

The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether

the modified quality system will continue to satisfy the requirements referred

to in point 3.2 or whether a re-assessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain

the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

(1)

The purpose of surveillance is to make sure that the manufacturer duly fulfils

the obligations arising out of the approved quality system.

(2)

The manufacturer shall, for assessment purposes, allow the notified body

access to the design, manufacture, inspection, testing and storage sites, and

shall provide it with all necessary information, in particular

(a) the quality system documentation;

(b) the quality records as provided for by the design part of the quality

system, such as results of analyses, calculations, tests.;

(c) the quality records as provided for by the manufacturing part of the

quality system, such as inspection reports and test data, calibration data,

qualification reports on the personnel concerned.

(3)

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and shall provide the

manufacturer with an audit report.

(4)

In addition, the notified body may pay unexpected visits to the manufacturer.

During such visits the notified body may, if necessary, carry out instrument

tests, or have them carried out, in order to check the proper functioning of the

quality system. It shall provide the manufacturer with a visit report and, if

tests have been carried out, with a test report.

5. Conformity marking and EU declaration of conformity

(1)

The manufacturer shall affix the CE marking, the supplementary metrology

marking set out in these regulations and, under the responsibility of the

notified body referred to in point 3.1, the latter’s identification number to

each individual instrument that satisfies the applicable requirements of these

regulations.

(2)

The manufacturer shall draw up a written EU declaration of conformity for

each instrument model and keep it at the disposal of the national authorities

for 10 years after the instrument has been placed on the market. The EU

declaration of conformity shall identify the instrument model for which it has

been drawn up.

A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request. A copy of the EU declaration of conformity

shall be supplied with each measuring instrument that is placed on the

market. However, this requirement may be interpreted as applying to a batch

or consignment rather than individual instruments in those cases where a

large number of instruments are delivered to a single user.

6. The manufacturer shall, for a period ending 10 years after the instrument has

been placed on the market, keep at the disposal of the national authorities

(a) the technical documentation referred to in point 3.1,

(b) the documentation concerning the quality system referred to in point 3.1,

(c) the information relating to the change referred to in point 3.5, as

approved;

(d) the decisions and reports of the notified body referred to in points 3.5,

4.3 and 4.4.

7. Each notified body shall inform the Authority of quality system approvals

issued or withdrawn, and shall, periodically or upon request, make available

to the Authority the list of quality system approvals refused, suspended or

otherwise restricted.

8. Authorised representative

The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be

fulfilled by his authorised representative, on his behalf and under his

responsibility, provided that they are specified in the mandate.

MODULE H1: CONFORMITY BASED ON

FULL

QUALITY

ASSURANCE PLUS DESIGN EXAMINATION

1. Conformity based on full quality assurance plus design examination is the

conformity assessment procedure whereby the manufacturer fulfils the

obligations laid down in points 2 and 6, and ensures and declares on his sole

responsibility that the measuring instruments concerned satisfy the

requirements of these regulations that apply to them.

2. Manufacturing

The manufacturer shall operate an approved quality system for design,

manufacture and final product inspection and testing of the measuring

instruments concerned as specified in point 3, and shall be subject to

surveillance as specified in point 5.

The adequacy of the technical design of the measuring instruments shall have

been examined in accordance with point 4.

3. Quality system

(1)

The manufacturer shall lodge an application for assessment of the quality

system with the notified body of his choice for the measuring instruments

concerned.

The application shall include

(a) the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as well;

(b) all relevant information for the instrument category envisaged;

(c) the documentation concerning the quality system;

(d) a written declaration that the same application has not been lodged with

any other notified body.

(2)

The quality system shall ensure compliance of the measuring instruments

with the requirements of these regulations that apply to them.

All the elements, requirements and provisions adopted by the manufacturer

shall be documented in a systematic and orderly manner in the form of

written policies, procedures and instructions. This quality system

documentation shall permit a consistent interpretation of the quality

programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of

(a) the quality objectives and the organisational structure, responsibilities

and powers of the management with regard to design and product

quality;

(b) the technical design specifications, including standards, that will be

applied and, where the relevant harmonised standards and/or normative

documents will not be applied in full, the means that will be used to

ensure that the essential requirements of these regulations that apply to

the measuring instruments will be met, applying other relevant technical

specifications;

(c) the design control and design verification techniques, processes and

systematic actions that will be used when designing the measuring

instruments pertaining to the instrument category covered;

(d) the corresponding manufacturing, quality control and quality assurance

techniques, processes and systematic actions that will be used;

(e) the examinations and tests that will be carried out before, during and

after manufacture, and the frequency with which they will be carried out;

(f) the quality records, such as inspection reports and test data, calibration

data, qualification reports on the personnel concerned;

(g) the means of monitoring the achievement of the required design and

product quality and the effective operation of the quality system.

(3)

The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in point 3.2. It shall presume conformity

with those requirements in respect of the elements of the quality system that

comply with the corresponding specifications of the relevant harmonised

standard.

In addition to experience in quality management systems, the auditing team

shall have at least one member experienced as an assessor in the relevant

instrument field and instrument technology concerned, and knowledge of the

applicable requirements of these regulations. The audit shall include an

assessment visit to the manufacturer’s premises.

The manufacturer or his authorised representative shall be notified of the

decision. The notification shall contain the conclusions of the audit and the

reasoned assessment decision.

(4)

The manufacturer shall undertake to fulfil the obligations arising out of the

quality system as approved and to maintain it so that it remains adequate and

efficient.

(5)

The manufacturer shall keep the notified body that has approved the quality

system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether

the modified quality system will continue to satisfy the requirements referred

to in point 3.2 or whether a re-assessment is necessary.

It shall notify the manufacturer or his authorised representative of its

decision. The notification shall contain the conclusions of the examination

and the reasoned assessment decision.

(6)

Each notified body shall inform the Authority of quality system approvals

issued or withdrawn, and shall periodically or upon request, make available

to the Authority the list of quality system approvals refused, suspended or

otherwise restricted.

4. Design examination

(1)

The manufacturer shall lodge an application for examination of the design

with the notified body referred to in point 3.1.

(2)

The application shall make it possible to understand the design, manufacture

and operation of the instrument, and to assess the conformity with the

requirements of these regulations that apply to it.

It shall include

(a) the name and address of the manufacturer;

(b) a written declaration that the same application has not been lodged with

any other notified body;

(c) the technical documentation as described in regulation 18. The

documentation shall make it possible to assess the instrument’s

conformity with the relevant requirements, and shall include an adequate

analysis and assessment of the risk(s). It shall, as far as relevant for such

assessment, cover the design and operation of the instrument;

(d) the supporting evidence for the adequacy of the technical design. This

supporting evidence shall mention any documents that have been used,

in particular where the relevant harmonised standards and/or normative

documents have not been applied in full, and shall include, where

necessary, the results of tests carried out in accordance with other

relevant technical specifications, by the appropriate laboratory of the

manufacturer, or by another testing laboratory on his behalf and under

his responsibility.

(3)

The notified body shall examine the application, and where the design meets

the requirements of these regulations that apply to the instrument it shall issue

an EU design examination certificate to the manufacturer. That certificate

shall give the name and address of the manufacturer, the conclusions of the

examination, the conditions (if any) for its validity and the data necessary for

identification of the approved design. That certificate may have one or more

schedules attached.

That certificate and its schedules shall contain all relevant information to

allow the conformity of manufactured measuring instruments with the

examined design to be evaluated and to allow for in-service control. It shall

allow the evaluation of conformity of the manufactured instruments with the

examined design regarding the reproducibility of their metrological

performances, when they are properly adjusted using appropriate means,

including

(a) the metrological characteristics of the design of the instrument;

(b) measures required for ensuring the integrity of the instruments (sealing,

identification of software, etc.);

(c) information on other elements necessary for the identification of the

instrument and to check its visual external conformity to the design;

(d) if appropriate, any specific information necessary to verify the

characteristics of manufactured instruments;

(e) in the case of a sub-assembly, all necessary information to ensure the

compatibility with other sub-assemblies or measuring instruments.

The notified body shall establish an evaluation report in this regard and keep

it at the disposal of the Member State that designated it. Without prejudice to

Article 27(10), the notified body shall release the content of this report, in full

or in part, only with the agreement of the manufacturer.

The certificate shall have a validity of 10 years from the date of its issue, and

may be renewed for subsequent periods of 10 years each.

Where the design does not satisfy the applicable requirements of these

regulations, the notified body shall refuse to issue an EU design examination

certificate and shall inform the applicant accordingly, giving detailed reasons

for its refusal.

(4)

The notified body shall keep itself appraised of any changes in the generally

acknowledged state of the art which indicate that the approved design may no

longer comply with the applicable requirements of these regulations, and

shall determine whether such changes require further investigation. If so, the

notified body shall inform the manufacturer accordingly.

The manufacturer shall keep the notified body that has issued the EU design

examination certificate informed of any modification to the approved design

that may affect the conformity with the essential requirements of these

regulations or the conditions for validity of the certificate. Such modifications

shall require additional approval – from the notified body that issued the EU

design examination certificate – in the form of an addition to the original EU

design examination certificate.

(5)

Each notified body shall inform the Authority of the EU design examination

certificates and/or any additions thereto which it has issued or withdrawn, and

shall, periodically or upon request, make available to the Authority the list of

certificates and/or any additions thereto refused, suspended or otherwise

restricted.

The Commission, the Member States and the other notified bodies may, on

request, obtain a copy of the EU design examination certificates and/or

additions thereto. On request, the Commission and the Member States may

obtain a copy of the technical documentation and of the results of the

examinations carried out by the notified body.

The notified body shall keep a copy of the EU design examination certificate,

its schedules and additions, as well as the technical file including the

documentation submitted by the manufacturer until the expiry of the validity

of the certificate.

(6)

The manufacturer shall keep a copy of the EU design examination certificate,

its schedules and additions with the technical documentation at the disposal

of the national authorities for 10 years after the instrument has been placed on

the market.

5. Surveillance under the responsibility of the notified body

The purpose of surveillance is to make sure that the manufacturer duly fulfils

the obligations arising out of the approved quality system.

(2)

The manufacturer shall, for assessment purposes, allow the notified body

access to the design, manufacture, inspection, testing and storage sites, and

shall provide it with all necessary information, in particular

(a) the quality system documentation;

(b) the quality records as provided for by the design part of the quality

system, such as results of analyses, calculations, tests, etc.;

(c) the quality records as provided for by the manufacturing part of the

quality system, such as inspection reports and test data, calibration data,

qualification reports on the personnel concerned, etc.

(3)

The notified body shall carry out periodic audits to make sure that the

manufacturer maintains and applies the quality system and shall provide the

manufacturer with an audit report.

(4)

In addition, the notified body may pay unexpected visits to the manufacturer.

During such visits the notified body may, if necessary, carry out instrument

tests, or have them carried out, in order to check the proper functioning of the

quality system. It shall provide the manufacturer with a visit report and, if

tests have been carried out, with a test report.

6. Conformity marking and EU declaration of conformity

(1)

The manufacturer shall affix the CE marking and the supplementary

metrology marking set out in these regulations, and, under the responsibility

of the notified body referred to in point 3.1, the latter’s identification number

to each individual instrument that satisfies the applicable requirements of

these regulations.

(2)

The manufacturer shall draw up a written EU declaration of conformity for

each instrument model and keep it at the disposal of the national authorities

for 10 years after the instrument has been placed on the market. The EU

declaration of conformity shall identify the instrument model for which it has

been drawn up and shall mention the number of the design examination

certificate.

A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request. A copy of the EU declaration of conformity

shall be supplied with each measuring instrument that is placed on the

market. However, this requirement may be interpreted as applying to a batch

or consignment rather than individual instruments in those cases where a

large number of instruments is delivered to a single user.

7. The manufacturer shall, for a period ending 10 years after the instrument has

been placed on the market, keep at the disposal of the national authorities

(a) the documentation concerning the quality system referred to in point 3.1,

(b) the information relating to the change referred to in point 3.5, as

approved;

(c) the decisions and reports of the notified body referred to in points 3.5,

5.3 and 5.4.

8. Authorised representative

The manufacturer’s authorised representative may lodge the application

referred to in points 4.1 and 4.2 and fulfil the obligations set out in points 3.1,

3.5, 4.4, 4.6, 6 and 7, on his behalf and under his responsibility, provided that

they are specified in the mandate.

(1)

Where instrument-specific schedules lay down the Applicability to

sub-assemblies.

* https://www.oiml.org/en

essential requirements for sub-assemblies, these regulations shall

mutatis mutandis apply to such sub-assemblies.

(2) Sub-assemblies and measuring instruments may be

assessed independently and separately for the purpose of establishing

conformity.

WATER METERS (MI-001)

The relevant requirements of Schedule I, the specific requirements of this

Schedule and the conformity assessment clean, cold or heated water in

residential, commercial and light industrial use procedures listed in this

Schedule, apply to water meters intended for the measurement of volumes of

DEFINITIONS

Water Meter

An instrument designed to measure, memorise and display the

volume at metering conditions of water passing through the

measurement transducer.

Minimum

The lowest flowrate at which the water meter provides

Flowrate (Q1)

indications that satisfy the requirements concerning the

maximum permissible errors (MPEs.)

Transitional

The transitional flowrate is the flowrate value occurring

Flowrate (Q2)

between the permanent and minimum flowrates, at which the

flowrate range is divided into two zones, the ‘upper zone’ and

the ‘lower zone’. Each zone has a characteristic MPE.

Permanent

The highest flowrate at which the water meter operates in a

Flowrate (Q3)

satisfactory manner under normal conditions of use, i.e. under

steady or intermittent flow conditions.

Overload

The overload flowrate is the highest flowrate at which the

Flowrate (Q4)

meter operates in a satisfactory manner for a short period of

time without deteriorating.

SPECIFIC REQUIREMENTS

Rated Operating Conditions

The manufacturer shall specify the rated operating conditions for the

instrument, in particular

1. The flowrate range of the water.

The values for the flowrate range shall fulfil the following conditions

Q3/Q1 ≥ 40

Q2/Q1 = 1,6

Q4/Q3 = 1,25

2. The temperature range of the water.

The values for the temperature range shall fulfil the following conditions

0,1°C to at least 30°C, or

30°C to at least 90°C.

The meter may be designed to operate over both ranges.

3. The relative pressure range of the water, the range being 0,3 bar to at least 10

bar at Q3.

4. For the power supply: the nominal value of the AC voltage supply and/or the

limits of DC supply.

MPE

5. The MPE, positive or negative, on volumes delivered at flowrates between

the transitional flowrate (Q2) (included) and the overload flowrate (Q4) is

2% for water having a temperature ≤ 30°C,

3% for water having a temperature > 30°C.

The meter shall not exploit the MPE or systematically favour any party.

6. The MPE, positive or negative, on volumes delivered at flowrates between

the minimum flowrate (Q1) and the transitional flowrate (Q2) (excluded) is

5% for water having any temperature.

The meter shall not exploit the MPE or systematically favour any party.

Permissible Effect of Disturbances

7(1) Electromagnetic immunity

7(1)(a)The effect of an electromagnetic disturbance on a water meter shall be

such that

the change in the measurement result is no greater than the critical

change value as defined in point 7(1)(c), or

the indication of the measurement result is such that it cannot be

interpreted as a valid result, such as a momentary variation that cannot

be interpreted, memorised or transmitted as a measuring result.

7(1)(b) After undergoing an electromagnetic disturbance the water meter

shall

recover to operate within MPE, and

have all measurement functions safeguarded, and

allow recovery of all measurement data present just before the

disturbance.

7(1)(c)The critical change value is the smaller of the two following values

the volume corresponding to half of the magnitude of the MPE in the

upper zone on the measured volume;

the volume corresponding to the MPE on the volume corresponding to

one minute at flowrate Q3.

(2)

Durability

After an appropriate test, taking into account the period of time estimated by

the manufacturer, has been performed, the following criteria shall be

satisfied

(2.1) The variation of the measurement result after the durability test, when

compared with the initial measurement result, shall not exceed

3% of the metered volume between Q1 included and Q2 excluded;

1,5% of the metered volume between Q2 included and Q4 included.

(2.2) The error of indication for the volume metered after the durability test shall

not exceed

± 6% of the metered volume between Q1 included and Q2 excluded;

-

± 2,5% of the metered volume between Q2 included and Q4 included

for water meters intended to meter water with a temperature between

0,1°C and 30°C,

-

± 3,5% of the metered volume between Q2 included and Q4 included

for water meters intended to meter water with a temperature between

30°C and 90°C.

8. Suitability

(1)

The meter shall be able to be installed to operate in any position unless

clearly marked otherwise.

(2)

The manufacturer shall specify whether the meter is designed to measure

reverse flow. In such a case, the reverse flow volume shall either be

subtracted from the cumulated volume or shall be separately recorded. The

same MPE shall apply to both forward and reverse flow.

Water meters not designed to measure reverse flow shall either prevent

reverse flow or shall withstand an accidental reverse flow without any

deterioration or change in metrological properties.

Units of Measurement

9. Metered volume shall be displayed in cubic metres.

Putting into Use

10. The Authority shall ensure that the requirements under points 1, 2 and 3 are

determined by the utility or the person legally designated for installing the

meter, so that the meter is appropriate for the accurate measurement of

consumption that is foreseen or foreseeable.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 17 that the

manufacturer can choose between are: B + F or B + D or H1.

The penalties applicable for the infringement of the

provisions of Regulation (EU) No 167/2013 shall be those provided

for in Part IV of the Product Safety Act.

GAS METERS AND VOLUME CONVERSION DEVICES (MI-002)

The relevant requirements of Schedule I, the specific requirements of this

Schedule and the conformity assessment procedures listed in this Schedule,

apply to gas meters and volume conversion devices defined below, intended

for residential, commercial and light industrial use.

An instrument designed to measure, memorise and display

the quantity of fuel gas (volume or mass) that has passed it.

A device fitted to a gas meter that automatically converts

the quantity measured at metering conditions into a quantity

at base conditions.

The lowest flowrate at which the gas meter provides

indications that satisfy the requirements regarding

maximum permissible error (MPE).

The highest flowrate at which the gas meter provides

indications that satisfy the requirements regarding MPE.

The transitional flowrate is the flowrate occurring between

the maximum and minimum flowrates at which the flowrate

range is divided into two zones, the ‘upper zone’ and the

‘lower zone’. Each zone has a characteristic MPE.

The overload flowrate is the highest flowrate at which the

meter operates for a short period of time without

deteriorating.

The specified conditions to which the measured quantity of

fluid is converted.

PART I

SPECIFIC REQUIREMENTS GAS METERS

1. Rated operating conditions

The manufacturer shall specify the rated operating conditions of the gas

meter, taking into account

The flowrate range of the gas shall fulfil at least the following conditions

Q max /

Q max /

Q r /

Q min

Qt

Q max

≥ 150

≥ 10

1,2

≥ 20

≥ 5

1,2

(2)

The temperature range of the gas, with a minimum range of 40°C.

(3)

The fuel/gas related conditions

The gas meter shall be designed for the range of gases and supply pressures

of the country of destination. In particular the manufacturer shall indicate

-

the gas family or group;

-

the maximum operating pressure.

(4)

A minimum temperature range of 50°C for the climatic environment.

(5)

The nominal value of the AC voltage supply and/or the limits of DC supply.

2. Maximum permissible error (MPEs)

(1)

Gas meter indicating the volume at metering conditions or mass

Table 1

Class

1,5

1,0

Q min ≤ Q < Qt

3%

2%

Qt ≤ Q ≤ Q max

1,5%

1%

The gas meter shall not exploit the MPEs or systematically favour any party.

(2)

For a gas meter with temperature conversion, which only indicates the

converted volume, the MPE of the meter is increased by 0,5% in a range of

30°C extending symmetrically around the temperature specified by the

manufacturer that lies between 15°C and 25°C. Outside this range, an

additional increase of 0,5% is permitted in each interval of 10°C.

3. Permissible effect of disturbances

(1)

Electromagnetic immunity

(1.1) The effect of an electromagnetic disturbance on a gas meter or volume

conversion device shall be such that

-

the change in the measurement result is no greater than the critical

change value as defined in point 3.1.3, or

-

the indication of the measurement result is such that it cannot be

interpreted as a valid result, such as a momentary variation that cannot

be interpreted, memorised or transmitted as a measuring result.

(1.2) After undergoing a disturbance, the gas meter shall

-

recover to operate within MPE, and

-

have all measurement functions safeguarded, and

-

allow recovery of all measurement data present just before the

disturbance.

(1.3) The critical change value is the smaller of the two following values

-

the quantity corresponding to half of the magnitude of the MPE in the

upper zone on the measured volume;

-

the quantity corresponding to the MPE on the quantity corresponding

to one minute at maximum flowrate.

(2)

Effect of upstream-downstream flow disturbances

Under installation conditions specified by the manufacturer, the effect of the

flow disturbances shall not exceed one third of the MPE.

4. Durability

After an appropriate test, taking into account the period of time estimated by

the manufacturer, has been performed, the following criteria shall be

satisfied

(1)

Class 1,5 $3

(1.1) The variation of the measurement result after the durability test when

compared with the initial measurement result for the flow rates in the range

Qt to Q max - shall not exceed the measurement result by more than 2%.

(1.2) The error of indication after the durability test shall not exceed twice the

MPE in point 2.

(2)

Class 1,0 $3

(2.1) The variation of the measurement result after the durability test when

compared with the initial measurement result shall not exceed one-third of

the MPE in point 2.

(2.2) The error of indication after the durability test shall not exceed the MPE in

point 2.

5. Suitability

A gas meter powered from the mains (AC or DC) shall be provided with an

emergency power supply device or other means to ensure, during a failure of

the principal power source, that all measuring functions are safeguarded.

(2)

A dedicated power source shall have a lifetime of at least five years. After

90% of its lifetime an appropriate warning shall be shown.

(3)

An indicating device shall have a sufficient number of digits to ensure that

the quantity passed during 8 000 hours at Q max does not return the digits to

their initial values.

(4)

The gas meter shall be able to be installed to operate in any position declared

by the manufacturer in its installation instruction.

(5)

The gas meter shall have a test element, which shall enable tests to be carried

out in a reasonable time.

(6)

The gas meter shall respect the MPE in any flow direction or only in one flow

direction clearly marked.

6. Units

Metered quantity shall be displayed in cubic metre, or in kilogram.

PART II

SPECIFIC REQUIREMENTS VOLUME CONVERSION DEVICES

A volume conversion device constitutes a sub-assembly when it is together

with a measuring instrument with which it is compatible.

For a volume conversion device, the essential requirements for the gas meter

shall apply, if applicable. In addition, the following requirements shall apply

7. Base conditions for converted quantities

The manufacturer shall specify the base conditions for converted quantities.

8. MPE

-

0,5% at ambient temperature 20°C ± 3°C, ambient humidity 60% ±

15%, nominal values for power supply;

-

0,7% for temperature conversion devices at rated operating conditions;

-

1% for other conversion devices at rated operating conditions. Note

The error of the gas meter is not taken into account.

The volume conversion device shall not exploit the MPEs or systematically

favour any party.

9. Suitability

(1)

An electronic conversion device shall be capable of detecting when it is

operating outside the operating range(s) stated by the manufacturer for

parameters that are relevant for measurement accuracy. In such a case, the

conversion device must stop integrating the converted quantity, and may

totalise separately the converted quantity for the time it is operating outside

the operating range(s).

(2)

An electronic conversion device shall be capable to display all relevant data

for the measurement without additional equipment.

PART III

PUTTING INTO USE AND CONFORMITY ASSESSMENT

Putting into use

10. (a) Where the Authority imposes measurement of residential use, it shall

allow such measurement to be performed by means of any Class 1,5 $3,

and by Class 1,0 $3 which have a Q max /Q min ratio equal or greater than

150. (b) Where the Authority imposes measurement of commercial and/or light

industrial use, it shall allow such measurement to be performed by any

Class 1,5 USD 3.

(c) As regards the requirements under points 1.2 and 1.3, the Authority shall

ensure that the properties be determined by the utility or the person

legally designated for installing the meter, so that the meter is

appropriate for the accurate measurement of consumption that is

foreseen or foreseeable.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 17 that the

manufacturer can choose between are

B + F or B + D or H1.

These regulations establish the requirements that

measuring instruments have to satisfy with a view to their being made

available on the market and, or put into use for the measuring tasks

referred to in these regulations.

ACTIVE ELECTRICAL ENERGY METERS (MI-003)

The relevant requirements of Schedule I, the specific requirements of this

Schedule and the conformity assessment procedures listed in this Schedule,

apply to active electrical energy meters intended for residential, commercial

and light industrial use.

Note

Electrical energy meters may be used in combination with external

instrument transformers, depending upon the measurement technique applied.

However, this Schedule covers only electrical energy meters but not

instrument transformers.

An active electrical energy meter is a device which measures the active

electrical energy consumed in a circuit.

the electrical current flowing through the meter;

the specified reference current for which the transformer operated

meter has been designed;

the lowest declared value of I at which the meter registers active

electrical energy at unity power factor (polyphase meters with balanced

load);

the value of I above which the error lies within maximum permissible

errors (MPEs) (polyphase meters with balanced load);

the value of I above which the error lies within the smallest MPE

corresponding to the class index of the meter;

the maximum value of I for which the error lies within the MPEs;

the voltage of the electricity supplied to the meter;

the specified reference voltage;

the frequency of the voltage supplied to the meter;

the specified reference frequency;

power factor = cosφ = the cosine of the phase difference φ between I

and U.

SPECIFIC REQUIREMENTS

1. The manufacturer shall specify the class index of the meter. The class indices

are defined as: Class A, B and C.

2. Rated operating conditions

The manufacturer shall specify the rated operating conditions of the meter; in

The values of fn, Un, In, Ist, Imin, Itr and Imax that apply to the meter. For

the current values specified, the meter shall satisfy the conditions given in

Table 1;

Table 1

Class A

Class B

Class C

For direct-connected

meters

I min

≤ 0,05 · I tr

≤ 0,04 · I tr

≤ 0,04 · I tr

I min

≤ 0,5 · I tr

≤ 0,5 · I tr

≤ 0,3 · I tr

I max

≥ 50 · I tr

≥ 50 · I tr

≥ 50 · I tr

For transformer-operated

meters

I st

≤ 0,06 · I tr

≤ 0,04 · I tr

≤ 0,02 · I tr

I n

= 20 · I tr

= 20 · I tr

= 20 · I tr

I max

≥ 1,2 · I n

≥ 1,2 · I n

≥ 1,2 · I n

(1) For Class B electromechanical meters I min ≤ 0,4 · I tr shall apply.

The voltage, frequency and power factor ranges within which the meter shall

satisfy the MPE requirements are specified in Table 2. These ranges shall

recognise the typical characteristics of electricity supplied by public

distribution systems.

The voltage and frequency ranges shall be at least

0,9 · Un ≤ U ≤ 1,1 · Un

0,98 · fn ≤ f ≤ 1,02 · fn

power factor range at least from cosφ = 0,5 inductive to cosφ = 0,8

capacitive.

3. MPEs

The effects of the various measurands and influence quantities (a, b, c,…) are

evaluated separately, all other measurands and influence quantities being kept

relatively constant at their reference values. The error of measurement, that

shall not exceed the MPE stated in Table 2, is calculated as

Error of measurement  ( a  b  c ...)

When the meter is operating under varying-load current, the percentage

errors shall not exceed the limits given in Table 2.

Table 2.

MPEs in percent at rated operating conditions and defined load current levels and

operating temperature

Operating

Operating

Operating

Operating

Temperatures

Temperatures

Temperatures

Temperatures

+ 5°C … + 30°C

– 10°C … + 5°C

– 25°C … – 10°C

– 40°C … – 25°C

or + 30°C … +

or + 40°C … +

or + 55°C … +

40°C

55°C

70°C

Meter Class

A

B

C

A

B

C

A

B

C

A

B

C

Single phase meter; polyphase meter if operating with balanced loads

3,5

2,5

1,3

3,5

1,7

I min  I < I tr

I tr  I  I max

3,5

0,7

4,5

2,5

3,5

1,3

1,5

Polyphase meter if operating with single phase load

I tr  I  I max, see

2,5

1,3

1,7

4,5

exception below

For electromechanical polyphase meters the current range for single-phase load is

limited to 5I tr  I  I max

When a meter operates in different temperature ranges the relevant MPE

values shall apply. The meter shall not exploit the MPEs or systematically

favour any party.

4. Permissible effect of disturbances

(1)

General

As electrical energy meters are directly connected to the mains supply and as

mains current is also one of the measurands, a special electromagnetic

environment is used for electricity meters.

The meter shall comply with the electromagnetic environment E2 and the

additional requirements in points 4.2 and 4.3.

The electromagnetic environment and permissible effects reflect the situation

that there are disturbances of long duration which shall not affect the

accuracy beyond the critical change values and transient disturbances, which

may cause a temporary degradation or loss of function or performance but

from which the meter shall recover and shall not affect the accuracy beyond

the critical change values.

When there is a foreseeable high risk due to lightning or where overhead

supply networks are predominant, the metrological characteristics of the

meter shall be protected.

4.2. Effect of disturbances of long duration

Table 3

Disturbance

Critical change values in

percent for meters of class

A

B

C

Reversed phase sequence

1.5

1.5

0.3

Voltage unbalance (only applicable to 4

polyphase meters)

Harmonic contents in the current circuits (1) 1

0.8

0.5

DC and harmonics in the current circuit (1)

1.5

Fast transient bursts

Magnetic fields; HF (radiated RF) 3

electromagnetic

field;

Conducted

disturbances introduced by radio-frequency

fields; and Oscillatory waves immunity

(1) In the case of electromechanical electricity meters, no critical change

values are defined for harmonic contents in the current circuits and for DC

and harmonics in the current circuit.

Critical change values for disturbances of long duration

(3)

Permissible effect of transient electromagnetic phenomena

(3.1) The effect of an electromagnetic disturbance on an electrical energy meter

shall be such that during and immediately after a disturbance

-

any output intended for testing the accuracy of the meter does not

produce pulses or signals corresponding to an energy of more than the

critical change value, and in reasonable time after the disturbance the

meter shall

-

recover to operate within the MPE limits, and

-

have all measurement functions safeguarded, and

-

allow recovery of all measurement data present prior to the

disturbance, and

-

not indicate a change in the registered energy of more than the critical

change value. The critical change value in kWh is m · Un · Imax · 10–

(m being the number of measuring elements of the meter, Un in Volts and

Imax in Amps).

(3.2) For overcurrent the critical change value is 1,5%.

5. Suitability

(1)

Below the rated operating voltage the positive error of the meter shall not

exceed 10%.

(2)

The display of the total energy shall have a sufficient number of digits to

ensure that when the meter is operated for 4 000 hours at full load (I = Imax,

U = Un and PF = 1) the indication does not return to its initial value and shall

not be able to be reset during use.

(3)

In the event of loss of electricity in the circuit, the amounts of electrical

energy measured shall remain available for reading during a period of at least

4 months.

(4)

Running with no load

When the voltage is applied with no current flowing in the current circuit

(current circuit shall be open circuit), the meter shall not register energy at

any voltage between 0,8 · Un and 1,1 Un.

(5)

Starting

The meter shall start and continue to register at Un, PF = 1 (polyphase meter

with balanced loads) and a current which is equal to Ist.

6. Units

The electrical energy measured shall be displayed in kilowatt-hours or in

megawatt-hours.

7. Putting into use

(a) Where the Authority imposes measurement of residential use, it shall

allow such measurement to be performed by means of any Class A

meter. For specified purposes Malta is authorised to require any Class B

meter.

(b) Where the Authority imposes measurement of commercial and/or light

industrial use, it shall allow such measurement to be performed by any

Class B meter. For specified purposes Malta is authorised to require any

Class C meter.

(c) The Authority shall ensure that the current range be determined by the

utility or the person legally designated for installing the meter, so that

the meter is appropriate for the accurate measurement of consumption

that is foreseen or foreseeable.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 17 that the

manufacturer can choose between are: B + F or B + D or H1.

(1) The Authority may prescribe the use of measuring

instruments for measuring tasks, where they consider it justified for

reasons of public interest, public health, public safety, public order,

protection of the environment, protection of consumers, levying of

taxes and duties and fair trading.

(2) If the Authority does not prescribe such use, it shall

communicate the reasons therefore to the Commission and the other

Member States.

THERMAL ENERGY METERS (MI-004)

The relevant requirements of Schedule I, the specific requirements and the

conformity assessment procedures listed in this Schedule, apply to thermal

energy meters defined below, intended for residential, commercial and light

industrial use.

DEFINITIONS

A thermal energy meter is an instrument designed to measure the thermal

energy which, in a thermal energy exchange circuit, is given up by a liquid

called the thermal energy-conveying liquid.

A thermal energy meter is either a complete instrument or a combined

instrument consisting of the sub-assemblies, flow sensor, temperature sensor

pair, and calculator, as defined in regulation 3(2), or a combination thereof

= the temperature of the thermal energy-conveying liquid;

θ in

= the value of θ at the inlet of the thermal energy exchange circuit;

θ οut

= the value of θ at the outlet of the thermal energy exchange

circuit;

Δθ

= the temperature difference θ in -θ οut with Δ θ ≥ 0;

= the upper limit of θ for the thermal energy meter to function

correctly within the MPEs;

= the lower limit of θ for the thermal energy meter to function

correctly within the MPEs;

= the upper limit of Δθ for the thermal energy meter to function

correctly within the MPEs;

= the lower limit of Δθ for the thermal energy meter to function

correctly within the MPEs;

= the flow rate of the thermal energy conveying liquid;

= the highest value of q that is permitted for short periods of time

for the thermal energy meter to function correctly;

= the highest value of q that is permitted permanently for the

thermal energy meter to function correctly;

= the lowest value of q that is permitted for the thermal energy

meter to function correctly;

= the thermal power of the thermal energy exchange;

= the upper limit of P that is permitted for the thermal energy meter

to function correctly.

SPECIFIC REQUIREMENTS

1. Rated operating conditions

The values of the rated operating conditions shall be specified by the

manufacturer as follows

(1)

For the temperature of the liquid: θ max , θ min ,

for the temperature differences: Δθ max , Δθ min ,

subject to the following restrictions: Δθ max /Δθ min ≥ 10; Δθ min = 3 K or 5 K or

10 K.

(2)

For the pressure of the liquid: The maximum positive internal pressure that

the thermal energy meter can withstand permanently at the upper limit of the

temperature.

(3) For the flow rates of the liquid: qs, qp, qi, where the values of qp and qi are

subject to the following restriction: qp/qi ≥ 10.

(4)

For the thermal power: Ps.

2. Accuracy classes

The following accuracy classes are defined for thermal energy meters: 1, 2, 3.

3. MPEs applicable to complete thermal energy meters

The maximum permissible relative errors applicable to a complete thermal

energy meter, expressed in percent of the true value for each accuracy class,

are

-

For class 1: E = Ef + Et + Ec, with Ef, Et, Ec according to points 7.1 to

7.3.

-

For class 2: E = Ef + Et + Ec, with Ef, Et, Ec according to points 7.1 to

7.3.

-

For class 3: E = Ef + Et + Ec, with Ef, Et, Ec according to points 7.1 to

7.3.

The complete thermal energy meter shall not exploit the MPEs or

systematically favour any party.

4. Permissible influences of electromagnetic disturbances

(1)

The instrument shall not be influenced by static magnetic fields and by

electromagnetic fields at mains frequency.

(2)

The influence of an electromagnetic disturbance shall be such that the change

in the measurement result is not greater than the critical change value as laid

down in requirement 4.3 or the indication of the measurement result is such

that it cannot be interpreted as a valid result.

(3)

The critical change value for a complete thermal energy meter is equal to the

absolute value of the MPE applicable to that thermal energy meter (see point

(3).

5. Durability

After an appropriate test, taking into account the period of time estimated by

the manufacturer, has been performed, the following criteria shall be

satisfied

(1)

Flow sensors: The variation of the measurement result after the durability

test, when compared with the initial measurement result, shall not exceed the

critical change value.

(2)

Temperature sensors: The variation of the measurement result after the

durability test, when compared with the initial measurement result, shall not

exceed 0,1°C.

6. Inscriptions on a thermal energy meter

-

Accuracy class

-

Limits of flow rate

-

Limits of temperature

-

Limits of temperature difference

-

Place of the flow sensor installation: flow or return

-

Indication of the direction of flow

7. Sub-assemblies

The provisions for sub-assemblies may apply to sub-assemblies

manufactured by the same or different manufacturers. Where a thermal

energy meter consists of sub-assemblies, the essential requirements for the

thermal energy meter apply to the sub-assemblies as relevant. In addition, the

following apply

(1)

The relative MPE of the flow sensor, expressed in%, for accuracy classes

-

Class 1: Ef = (1 + 0,01 qp/q), but not more than 5%,

-

Class 2: Ef = (2 + 0,02 qp/q), but not more than 5%,

-

Class 3: Ef = (3 + 0,05 qp/q), but not more than 5%,

where the error Ef relates the indicated value to the true value of the

relationship between flow sensor output signal and the mass or the volume.

(2)The relative MPE of the temperature sensor pair, expressed in%

-

Et = (0,5 + 3 · Δθmin/Δθ),

where the error Et relates the indicated value to the true value of the

relationship between temperature sensor pair output and temperature

difference.

(3)

The relative MPE of the calculator, expressed in%

-

Ec = (0,5 + Δθmin/Δθ),

where the error Ec relates the value of the thermal energy indicated to the true

value of the thermal energy.

(4)

The critical change value for a sub-assembly of a thermal energy meter is

equal to the respective absolute value of the MPE applicable to the sub-

assembly (see points 7.1, 7.2 or 7.3).

(5)

Inscriptions on the sub-assemblies

Flow

Accuracy class

sensor

Limits of flow rate

Limits of temperature

Nominal meter factor (e.g. litres/pulse) or corresponding output

signal

Indication of the direction of flow

Temperature Type identification (e.g. P t 100)

sensor pair

Limits of temperature

Limits of temperature difference

Calculator

Type of temperature sensors

- Limits of temperature

- Limits of temperature difference

-Required nominal meter factor (e.g. litres/pulse) or corresponding

input signal coming from the flow sensor

-Place of the flow sensor installation: flow or return

8. PUTTING INTO USE

(a) Where the Authority imposes measurement of residential use, it shall

allow such measurement to be performed by means of any Class 3 meter.

(b) Where the Authority imposes measurement of commercial and/or light

industrial use, it is authorised to require any Class 2 meter.

(c) As regards the requirements under points 1.1 to 1.4, the Authority shall

ensure that the properties be determined by the utility or the person

legally designated for installing the meter, so that the meter is

appropriate for the accurate measurement of consumption that is

foreseen or foreseeable.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 17 that the

manufacturer can choose between are: B + F or B + D or H1.

(1) A measuring instrument shall meet the essential

requirements set out in Schedule I and in the relevant instrument-

specific Schedules.

(2) For the correct use of the instrument, the information

referred to in point 9 of Schedule I or in the relevant instrument-

specific Schedules may be provided in at least English and, or

Maltese.

MEASURING SYSTEMS FOR THE CONTINUOUS AND DYNAMIC

MEASUREMENT OF QUANTITIES OF LIQUIDS OTHER THAN

WATER (MI-005)

The relevant essential requirements of Schedule I, the specific requirements

of this Schedule and the conformity assessment procedures listed in this

Schedule, apply to measuring systems intended for the continuous and

dynamic measurement of quantities (volumes or masses) of liquids other than

water. If appropriate, the terms ‘volume and L’ in this Schedule can be read

as: ‘mass and kg’.

An instrument designed to measure continuously, memorise

and display the quantity at metering conditions of liquid

flowing through the measurement transducer in a closed,

fully charged conduit.

A part of a meter that receives the output signals from the

measurement transducer(s) and possibly, from associated

measuring instruments and displays the measurement results.

An instrument connected to the calculator for measuring

certain quantities which are characteristic of the liquid, with

a view to make a correction and/or conversion.

Conversion Device A part of the calculator which by taking account of the

characteristics of the liquid (temperature, density, etc.)

measured using associated measuring instruments, or stored

in a memory, automatically converts

-

the volume of the liquid measured at metering

conditions into a volume at base conditions

and/or into mass, or

-

the mass of the liquid measured at metering

conditions into a volume at metering

conditions and/or into a volume at base

conditions

Note

A conversion device includes the relevant associated

measuring instruments.

The specified conditions to which the measured quantity of

liquid at metering conditions is converted.

A system that comprises the meter itself and all devices

required to ensure correct measurement or intended to

facilitate the measuring operations.

A measuring system intended for the refuelling of motor

vehicles, small boats and small aircraft.

An arrangement that allows the customer to use a measuring

system for the purpose of obtaining liquid for his own use.

Self-service device A specific device that is part of a self-service arrangement

and which allows one of more measuring systems to perform

in this self-service arrangement.

The smallest quantity of liquid for which the measurement is

measured quantity metrological acceptable for the measuring system.

The indication, either volume or mass, corresponding to the

measure and that the meter is physically capable of

measuring. Note: The direct indication may be converted

into another quantity using a conversion device.

A measuring system is considered as interruptible/non-

interruptible when the liquid flow can/cannot be stopped

easily and rapidly.

The range between the minimum flowrate (Q min ) and

maximum flowrate (Q max ).

SPECIFIC REQUIREMENTS

1. Rated operating conditions

The manufacturer shall specify the rated operating conditions for the

instrument, in particular;

(1)

The flowrate range

The flowrate range is subject to the following conditions

(i) the flowrate range of a measuring system shall be within the flowrate

range of each of its elements, in particular the meter.

(ii) meter and measuring system

Table 1

Specific

Minimum ratio of Q max : Q min

measuring

Characteristic of liquid

system

Fuel dispensers

Not Liquefied gases

10: 1

Liquefied gases

5: 1

Measuring

Cryogenic liquids

5:1

system

Measuring

All liquids

Suitable for use

systems on

pipeline and

systems for

loading ships

All other

All liquids

4:1

measuring

systems

(2)

The properties of the liquid to be measured by the instrument by specifying

the name or type of the liquid or its relevant characteristics, for example

-

Temperature range;

-

Pressure range;

-

Density range;

-

Viscosity range.

(3)

The nominal value of the AC voltage supply and/or limits of the DC voltage

supply.

(4)

The base conditions for converted values.

Note

Point 1.4 is without prejudice to the Authority’s obligations to require use of

a temperature of either 15°C in accordance with Article 12(2) of Council

Regulation 2003/96/EC of 27 October 2003 restructuring the Community

framework for the taxation of energy products and electricity (1).

2. Accuracy classification and maximum permissible errors (MPEs)

(1)

For quantities equal to or greater than 2 litres the MPE on indications is

Table 2

Accuracy Class

0,3

0,5

1,0

1,5

2,5

Measuring

0,3%

0,5%

1,0%

1,5%

2,5%

systems (A)

Meters (B)

0,2%

0,3%

0,6%

1,0%

1,5%

(1)

OJ L 283, 31.10.2003, p. 51.

(2)

For quantities less than two litres the MPE on indications is

Table 3

Measured volume V

MPE

V < 0,1 l

4 × value in Table 2, applied to 0,1 L

0,1 l ≤ V < 0,2 l

4 × value in Table 2

0,2 l ≤ V < 0,4 l

2 × value in Table 2, applied to 0,4 L

0,4 l ≤ V < 1 l

2 × value in Table 2

1 l ≤ V < 2 l

Value in Table 2, applied to 2 L

(3)

However, no matter what the measured quantity may be, the magnitude of the

MPE is given by the greater of the following two values

-

the absolute value of the MPE given in Table 2 or Table 3,

-

the absolute value of the MPE for the minimum measured quantity

(E min ).

(4.1) For minimum measured quantities greater than or equal to 2 litres the

following conditions apply: Condition 1

E min shall fulfil the condition: E min ≥ 2 R, where R is the smallest scale

interval of the indication device. Condition 2

E min is given by the formula: E min = (2MMQ) × (A/100), where

-

MMQ is the minimum measured quantity,

-

A is the numerical value specified in line A of Table 2.

(4.2) For minimum measured quantities of less than two litres, the above

mentioned condition 1 applies and E min is twice the value specified in Table

3, and related to line A of Table 2.

(5)

Converted indication

In the case of a converted indication the MPEs are as in line A of Table 2.

(6) Conversion devices

MPEs on converted indications due to a conversion device are equal to ± (A -

B), A and B being the values specified in Table 2.

Parts of conversion devices that can be tested separately

(a) Calculator

MPEs on quantities of liquid indications applicable to calculation, positive or

negative, are equal to one-tenth of the MPEs as defined in line A of Table 2.

(b) Associated measuring instruments

Associated measuring instruments shall have accuracy at least as good as the

values in Table 4

Table 4

MPE

on Accuracy classes of the measuring system

Measurements

0,3

0,5

1,0

1,5

2,5

Temperature

±0,3°C

± 0,5°C

± 1,0°C

MPE

on Accuracy classes of the measuring system

Measurements

0,3

0,5

1,0

1,5

2,5

Pressure

Less than 1 MPa: ± 50 kPa

From 1 to 4 MPa: ± 5%

Over 4 MPa: ± 200 kPa

Density

± 1 kg/m 3

± 2 kg/m 3

±5 kg/m 3

These values apply to the indication of the characteristic quantities of the

liquid displayed by the conversion device.

(c) Accuracy for calculating function

The MPE for the calculation of each characteristic quantity of the liquid,

positive or negative is equal to two fifths of the value fixed in (b).

(7)

The requirement (a) in point 2.6 applies to any calculation, not only

conversion.

(8)

The measuring system shall not exploit the MPEs or systematically favour

any party.

3. Maximum permissible effect of disturbances

(1)

The effect of an electromagnetic disturbance on a measuring system shall be

one of the following

-

the change in the measurement result is not greater than the critical

change value as defined in point 3.2, or

-

the indication of the measurement result shows a momentary variation

that cannot be interpreted, memorised or transmitted as a measuring

result. Furthermore, in the case of an interruptible system, this can also

mean the impossibility to perform any measurement, or

-

the change in the measurement result is greater than the critical change

value, in which case the measuring system shall permit the retrieval of

the measuring result just before the critical change value occurred and

cut off the flow.

(2)

The critical change value is the greater of MPE/5 for a particular measured

quantity or E min .

4. Durability

After an appropriate test, taking into account the period of time estimated by

the manufacturer, has been performed, the following criterion shall be

satisfied

The variation of the measurement result after the durability test, when

compared with the initial measurement result, shall not exceed the value for

meters specified in line B of table 2.

5. Suitability

(1)

For any measured quantity relating to the same measurement, the indications

provided by various devices shall not deviate one from another by more than

one scale interval where devices have the same scale interval. In the case

where the devices have different scale intervals, the deviation shall not be

more than that of the greatest scale interval.

However, in the case of a self-service arrangement the scale intervals of the

main indicating device on the measuring system and the scale intervals of the

self-service device shall be the same and results of measurement shall not

deviate one from another.

(2) It shall not be possible to divert the measured quantity in normal conditions of

use unless it is readily apparent.

(3)

Any percentage of air or gas not easily detectable in the liquid shall not lead

to a variation of error greater than

-

0,5% for liquids other than potable liquids and for liquids of a

viscosity not exceeding 1 mPa.s, or

-

1% for potable liquids and for liquids of a viscosity exceeding 1 mPa.s.

However, the allowed variation shall never be smaller than 1% of MMQ.

This value applies in the case of air or gas pockets.

(4) Instruments for direct sales

(4.1) A measuring system for direct sales shall be provided with means for

resetting the display to zero.

It shall not be possible to divert the measured quantity.

(4.2) The display of the quantity on which the transaction is based shall be

permanent until all parties in the transaction have accepted the measurement

result.

(4.3) Measuring systems for direct sales shall be interruptible.

(4.4) Any percentage of air or gas in the liquid shall not lead to a variation of error

greater than the values specified in point 5.3.

(5)

Fuel Dispensers

(5.1) Displays on fuel dispensers shall not be capable of being reset to zero during

a measurement.

(5.2) The start of a new measurement shall be inhibited until the display has been

reset to zero.

(5.3) Where a measuring system is fitted with a price display, the difference

between the indicated price and the price calculated from the unit price and

the indicated quantity shall not exceed the price corresponding to E min .

However this difference need not be less than the smallest monetary value.

6. Power supply failure

A measuring system shall either be provided with an emergency power

supply device that will safeguard all measuring functions during the failure of

the main power supply device or be equipped with means to save and display

the data present in order to permit the conclusion of the transaction in

progress and with means to stop the flow at the moment of the failure of the

main power supply device.

7. Putting into use

Accuracy Types of Measuring system

Measuring systems on pipeline

All measuring systems if not differently stated elsewhere in this Table,

in particular

-

fuel dispensers (not for liquefied gases),

-

measuring systems on road tankers for liquids of low

viscosity (< 20 mPa.s)

-

measuring systems for (un)loading ships and rail and

road tankers (1)

-

measuring systems for milk - measuring systems for

refuelling aircraft

Measuring systems for liquefied gases under pressure measured at a

temperature equal to or above – 10°C

Measuring systems normally in class 0,3 or 0,5 but used for liquids

-

whose temperature is less than – 10°C or greater than

50°C

-

whose dynamic viscosity is higher than 1 000 mPa.s

-

whose maximum volumetric flowrate is not higher than

20 L/h

Measuring systems for liquefied carbon dioxide

Measuring systems for liquefied gases under pressure measured at a

temperature below – 10°C (other than cryogenic liquids)

measuring systems for cryogenic liquids (temperature below – 153°C)

(1) However, the Authority may require measuring systems of accuracy class 0,3

or 0,5 when used for the levying of duties on mineral oils when (un)loading ships

and rail and road tankers. Note: However, the manufacturer may specify a better

accuracy for a certain type of measuring system.

8. Units of measurement

The metered quantity shall be displayed in millilitres, cubic centimetres,

litres, cubic metres, grams, kilograms or tonnes.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 17 that the

manufacturer can choose between are: B + F or B + D or H1 or G.

(1) The making available on the market and, or putting

into use of any measuring instrument that satisfies the requirements

of these regulations shall not be impeded for reasons covered by these

regulations.

(2) The Authority shall take all appropriate measures to ensure

that measuring instruments are made available on the market and/or

put into use only if they satisfy the requirements of these regulations.

(3) A measuring instrument may be required to satisfy the

provisions governing its putting into use that are justified by local

climatic conditions. In such a case, the Authority shall choose

appropriate upper and lower temperature limits from Table 1 of

Schedule I and may specify humidity conditions (condensing or non-

condensing) and whether the intended location of use is open or

closed.

(4) When different accuracy classes are defined for a

measuring instrument

(a)

the instrument-specific Schedules under the heading

‘Putting into use’ may indicate the accuracy classes to be used

for specific applications;

(b) in all other cases the Authority may determine the

accuracy classes to be used for specific applications within the

classes defined, subject to allowing the use of all accuracy

classes on its territory;

(c)

for the purposes of paragraph (a) or paragraph (b),

measuring instruments of a better accuracy class may be used if

the owner so chooses.

(5) At trade fairs, exhibitions, demonstrations or similar

events, the showing of measuring instruments not in conformity with

these regulations shall not be prevented

Provided that a visible sign clearly indicates their non-

conformity and their non-availability for making available on the

market and/or putting into use until they are brought into conformity.

AUTOMATIC WEIGHING INSTRUMENTS (MI-006)

The relevant essential requirements of Schedule I, the specific requirements

of this Schedule and the conformity assessment procedures listed in Chapter I

of this Schedule, apply to automatic weighing instruments defined below,

intended to determine the mass of a body by using the action of gravity on

that body.

DEFINITIONS

An instrument that determines the mass of a product without the

intervention of an operator and follows a predetermined programme

of automatic processes characteristic of the instrument.

An automatic weighing instrument that determines the mass of pre-

assembled discrete loads (for example prepackages) or single loads

of loose material.

An automatic catchweigher that subdivides articles of different

mass into two or more subgroups according to the value of the

difference of their mass and a nominal set- point.

An automatic catchweigher that labels individual articles with the

weight value.

An automatic catchweigher that labels individual articles with the

weight value, and price information.

An automatic weighing instrument that fills containers with a

predetermined and virtually constant mass of product from bulk.

Discontinuous

An automatic weighing instrument that determines the mass of a

totaliser

bulk product by dividing it into discrete loads. The mass of each

(totalising

discrete load is determined in sequence and summed. Each discrete

hopper

load is then delivered to bulk.

weigher)

Continuous

An automatic weighing instrument that continuously determines the

totaliser

mass of a bulk product on a conveyor belt, without systematic

subdivision of the product and without interrupting the movement

of the conveyor belt.

An automatic weighing instrument having a load receptor inclusive

weighbridge

of rails for conveying railway vehicles.

SPECIFIC REQUIREMENTS

CHAPTER I

Requirements common to all types of automatic weighing instruments

1. Rated Operating Conditions

The manufacturer shall specify the rated operating conditions for the

instrument as follows

(1)

For the measurand

The measuring range in terms of its maximum and minimum capacity.

(2)

For the electrical supply influence quantities

In case of AC voltage

the nominal AC voltage supply, or the AC

supply

voltage limits.

In case of DC voltage

the nominal and minimum DC voltage supply, or

supply

the DC voltage limits.

(3)

For the mechanical and climatic influence quantities

The minimum temperature range is 30°C unless specified otherwise in the

following chapters of this Schedule. The mechanical environment classes

according to Schedule I, point 1.3.2 are not applicable. For instruments which

are used under special mechanical strain, e.g. instruments incorporated into

vehicles, the manufacturer shall define the mechanical conditions of use.

(4)

For other influence quantities (if applicable): The rate(s) of operation.

The characteristics of the product(s) to be weighed.

2. Permissible effect of disturbances -Electromagnetic environment

The required performance and the critical change value are given in the

relevant Chapter of this Schedule for each type of instrument.

3. Suitability

(1)

Means shall be provided to limit the effects of tilt, loading and rate of

operation such that maximum permissible errors (MPEs) are not exceeded in

normal operation.

(2)

Adequate material handling facilities shall be provided to enable the

instrument to respect the MPEs during normal operation.

(3)

Any operator control interface shall be clear and effective.

(4)

The integrity of the display (where present) shall be verifiable by the

operator.

(5)

Adequate zero setting capability shall be provided to enable the instrument to

respect the MPEs during normal operation.

(6)

Any result outside the measurement range shall be identified as such, where a

printout is possible.

4. Conformity assessment

The conformity assessment procedures referred to in Article 17 that the

manufacturer can choose between are: For mechanical systems

B + D or B + E or B + F or D1 or F1 or G or H1. For electromechanical

instruments

B + D or B + E or B + F or G or H1.

For electronic systems or systems containing software: B + D or B + F or G

or H1.

CHAPTER II

Automatic Catchweighers

1. Accuracy Classes

(1)

Instruments are divided into primary categories designated by: X or Y as

specified by the manufacturer.

(2)

These primary categories are further divided into four accuracy classes: XI,

XII, XIII & XIIII and Y(I), Y(II), Y(a) & Y(b) which shall be specified by the

manufacturer.

2. Category X Instruments

(1)

Category X applies to instruments used to check prepackages made up in

accordance with the requirements of Council Regulation 76/211/EEC of 20

January 1976 on the approximation of the laws of Malta relating to the

making-up by weight or by volume of certain prepackaged products (1)

applicable to prepackages.

(2)

The accuracy classes are supplemented by a factor (x) that quantifies the

maximum permissible standard deviation as specified in point 4.2.

The manufacturer shall specify the factor (x), where (x) shall be ≤ 2 and in

the form 1 × 10k, 2 × 10k or 5 × 10k, where k is a negative whole number or

zero.

3. Category Y Instruments

Category Y applies to all other automatic catchweighers

4. MPE

(1)

Mean error Category X/MPE Category Y instruments

Table1

Net Load (m) in verification scale intervals (e)

Maximum

Maximum

permissible

permissible

mean error

error

Y(I)

XII

Y(II)

XIII

Y(a)

XIIII

Y(b)

X

Y

0 < m ≤ 50

0 < m ≤ 5

0 < m ≤ 500

0 < m ≤ 50

± 0,5 e

± 1 e

50 000 <

5 000 < m ≤

500 < m ≤ 2

50 < m ≤ 200

± 1,0 e

± 1,5 e

m ≤ 200

20 000

200 000 <

20 000 < m ≤

2 000 < m ≤

200 < m ≤ 1 000

± 1,5 e

± 2 e

100 000

10 000

(2)

Standard deviation

Maximum permissible value for the standard deviation of a class X (x)

instrument is the result of the multiplication of the factor (x) by the value in

Table 2 below.

Table 2

Net Load (m)

Maximum permissible

standard

deviation for class X(1)

m ≤ 50 g

0,48%

50 g < m ≤ 100 g

0,24 g

100 g < m ≤ 200 g

0,24%

200 g < m ≤ 300 g

0,48 g

300 g < m ≤ 500 g

0,16%

500 g < m ≤ 1 000 g

0,8 g

1 000 g < m ≤ 10 000 g

0,08%

10 000 g < m ≤ 15 000 g

8 g

15 000 g < m

0,053%

For class XI and XII (x) shall be less than 1.

For class XIII (x) shall be not greater than 1.

(1)

OJ L 46, 21.2.1976, p. 1.

For class XIIII (x) shall be greater than 1.

(3)

Verification scale interval -single interval instruments

Table 3

Accuracy classes

Verification

scale Number of verification

interval

intervals n = Max/e

Minimum

Y(I)

0,001 g ≤ e

50 000

XII

Y(II)

0,001 g ≤ e ≤ 0,05 g

0,1 g ≤ e

5 000

XIII

Y(a)

0,1 g ≤ e ≤ 2 g

5 g ≤ e

XIIII Y(b)

5 g ≤ e

(4)

Verification scale interval -multi-interval instruments

Table 4

Accuracy classes

Verification

scale Number of verification scale intervals

interval

n = Max/e

Minimum value (1)

Maximum

n = Maxi / e (i=1)

n = Maxi / e i

Y(I)

0,001 g ≤ e i

50 000

-

Y(II)

0,001 g ≤ e i ≤ 0,05 g 5 000

100 000

0,1 g ≤ e i

5 000

100 000

Y(a)

0,1 g ≤ e i

10 000

XIIII

Y(b)

5 g ≤ e i

1 000

(1) For i = r the corresponding column of Table 3 applies with e replaced by e r .

Where

i = 1, 2, … r

i = partial weighing range

r = total number of partial ranges

5. Measurement Range

In specifying the measurement range for class Y instruments the

manufacturer shall take account that the minimum capacity shall not be less

than

class Y(I)

: 100 e

class Y(II)

: 20 e for 0,001 g ≤ e ≤ 0,05 g, and 50 e

for 0,1 g ≤ e

class Y(a)

: 20 e

class Y(b)

: 10 e

Scales used for grading, e.g.

: 5 e

postal scales and garbage

weighers

6. Dynamic Setting

(1)

The dynamic setting facility shall operate within a load range specified by the

manufacturer.

(2)

When fitted, a dynamic setting facility that compensates for the dynamic

effects of the load in motion shall be inhibited from operating outside the load

range, and shall be capable of being secured.

7. Performance under Influence Factors and Electromagnetic Disturbances

(1)

The MPEs due to influence factors are

(1.1) For category X instruments

-

For automatic operation; as specified in Tables 1 and 2,

-

For static weighing in non-automatic operation; as specified in Table

1. (1.2) For category Y instruments

-

For each load in automatic operation; as specified in Table 1,

-

For static weighing in non-automatic operation; as specified for

category X in Table 1.

(2)

The critical change value due to a disturbance is one verification scale

interval.

(3)

Temperature range

-

For class XI and Y(I) the minimum range is 5°C,

-For class XII and Y(II) the minimum range is 15°C.

CHAPTER III

Automatic Gravimetric Filling Instruments

1. Accuracy classes

(1)

The manufacturer shall specify both the reference accuracy class Ref(x) and

the operational accuracy class(es) X(x).

(2)

An instrument type is designated a reference accuracy class, Ref(x),

corresponding to the best possible accuracy for instruments of the type. After

installation, individual instruments are designated for one or more operational

accuracy classes, X(x), having taken account of the specific products to be

weighed. The class designation factor (x) shall be ≤ 2, and in the form 1 ×

10k, 2 × 10k or 5 × 10k where k is a negative whole number or zero.

(3)

The reference accuracy class, Ref(x) is applicable for static loads.

(4)

For the operational accuracy class X(x), X is a regime relating accuracy to

load weight and (x) is a multiplier for the limits of error specified for class

X(1) in point 2.2.

2. MPE

(1)

Static weighing error

(1.1) For static loads under rated operating conditions, the MPE for reference

accuracy class Ref(x), shall be 0,312 of the maximum permissible deviation

of each fill from the average; as specified in Table 5; multiplied by the class

designation factor (x).

(1.2) For instruments where the fill may be made up from more than one load (e.g.

cumulative or selective combination weighers) the MPE for static loads shall

be the accuracy required for the fill as specified in point 2.2 (i.e. not the sum

of the maximum permissible deviation for the individual loads).

(2)

Deviation from average fill

Table 5

Value of the mass, m (g), of the fills

Maximum permissible deviation of

each fill from the average for class

m ≤ 50

7,2%

50 < m ≤ 100

3,6 g

100 < m ≤ 200

3,6%

200 < m ≤ 300

7,2 g

300 < m ≤ 500

2,4%

500 < m ≤ 1 000

12 g

1 000 < m ≤ 10 000

1,2%

10 000 < m ≤ 15 000

120 g

15 000 < m

0,8%

Note

The calculated deviation of each fill from the average may be adjusted to take

account for the effect of material particle size.

(3)

Error relative to pre-set value (setting error)

For instruments where it is possible to pre-set a fill weight; the maximum

difference between the pre-set value and the average mass of the fills shall

not exceed 0,312 of the maximum permissible deviation of each fill from the

average, as specified in Table 5.

3. Performance Under Influence Factor And Electromagnetic Disturbance

(1)

The MPE due to influence factors shall be as specified in point 2.1.

(2)

The critical change value due to a disturbance is a change of the static weight

indication equal to the MPE as specified in point 2.1 calculated for the rated

minimum fill, or a change that would give equivalent effect on the fill in the

case of instruments where the fill consists of multiple loads. The calculated

critical change value shall be rounded to the next higher scale interval (d).

(3)

The manufacturer shall specify the value of the rated minimum fill.

CHAPTER IV

Discontinuous Totalisers

1. Accuracy Classes

Instruments are divided into four accuracy classes as follows: 0,2; 0,5; 1; 2.

2. MPEs

Table 6

Accuracy class

MPE of totalised load

0,2

± 0,10%

0,5

± 0,25%

± 0,50%

± 1,00%

3. Totalisation scale interval

The totalisation scale interval (dt) shall be in the range

0,01% Max ≤ dt ≤ 0,2% Max

4. Minimum Totalised Load (Σ min )

The minimum totalised load (Σ min ) shall be not less than the load at which the

MPE is equal to the totalisation scale interval (dt) and not less than the

minimum load as specified by the manufacturer.

5. Zero Setting

Instruments that do not tare weigh after each discharge shall have a zero

setting device. Automatic operation shall be inhibited if zero indication varies

by

-

1 dt on instruments with automatic zero setting device;

-

0,5 dt on instruments with a semi-automatic, or non-automatic, zero

setting device.

6. Operator Interface

Operator adjustments and reset function shall be inhibited during automatic

operation.

7. Printout

On instruments equipped with a printing device, the reset of the total shall be

inhibited until the total is printed. The printout of the total shall occur if

automatic operation is interrupted.

8. Performance under influence factors and electromagnetic disturbances

(1)

The MPEs due to influence factors shall be as specified in Table 7.

Table 7

Load (m) in totalisation scale intervals (dt)

MPE

0 < m ≤ 500

± 0,5 dt

500 < m ≤ 2 000

± 1,0 dt

2 000 < m ≤ 10 000

± 1,5 dt

(2)

The critical change value due to a disturbance is one totalisation scale

interval for any weight indication and any stored total.

CHAPTER V

Continuous Totalisers

1. Accuracy classes

Instruments are divided into three accuracy classes as follows: 0,5; 1; 2.

2. Measurement Range

(1)

The manufacturer shall specify the measurement range, the ratio between the

minimum net load on the weighing unit and the maximum capacity, and the

minimum totalised load.

(2)

The minimum totalised load Σ min shall not be less than

800 d for class 0.5,

400 d for class 1,

200 d for class 2.

Where d is the totalisation scale interval of the general totalisation device.

3. MPE

Table 8

Accuracy class

MPE for totalised load

0,5

± 0,25%

± 0,5%

± 1,0%

4. Speed of the belt

The speed of the belt shall be specified by the manufacturer. For single-speed

beltweighers, and variable-speed beltweighers having a manual speed setting

control, the speed shall not vary by more than 5% of the nominal value. The

product shall not have a different speed than the speed of the belt.

5. General Totalisation Device

It shall not be possible to reset the general totalisation device to zero.

6. Performance under influence factors and electromagnetic disturbances

(1) The MPE due to influence factor, for a load not less than the Σ min , shall

be 0,7 times the appropriate value specified in Table 8, rounded to the

nearest totalisation scale interval (d).

(2) The critical change value due to a disturbance shall be 0,7 times the

appropriate value specified in Table 8, for a load equal to Σ min , for the

designated class of the beltweigher; rounded up to the next higher

totalisation scale interval (d).

CHAPTER VI

Automatic Rail Weighbridges

1. Accuracy classes

Instruments are divided into four accuracy classes as follows

0,2; 0,5; 1; 2.

2. MPE

(1)

The MPEs for weighing-in-motion of a single wagon or a total train are

shown in Table 9.

Table 9

Accuracy class

MPE

0,2

± 0,1%

0,5

± 0,25%

± 0,5%

± 1,0%

(2)

The MPEs for the weight of coupled or uncoupled wagons weighing-in-

motion shall be one of the following values, whichever is the greatest

the value calculated according to Table 9, rounded to the nearest scale

interval;

the value calculated according to Table 9, rounded to the nearest scale

interval for a weight equal to 35% of the maximum wagon weight (as

inscribed on the descriptive markings);

one scale interval (d).

(3)

The MPEs for the weight of train weighing-in-motion shall be one of the

following values, whichever is the greatest

the value calculated according to Table 9, rounded to the nearest scale

interval;

the value calculated according to Table 9, for the weight of a single

wagon equal to 35% of the maximum wagon weight (as inscribed on

the descriptive markings) multiplied by the number of reference

wagons (not exceeding 10) in the train, and rounded to the nearest

scale interval;

one scale interval (d) for each wagon in the train, but not exceeding 10

d.

(4)

When weighing coupled wagons; the errors of not more than 10% of the

weighing results taken from one or more passes of the train may exceed the

appropriate MPE given in point 2.2, but shall not exceed twice the MPE.

3. Scale interval (d)

The relationship between the accuracy class and the scale interval shall be as

specified in Table 10.

Accuracy class

Scale interval (d)

0,2

d ≤ 50 kg

0,5

d ≤ 100 kg

d ≤ 200 kg

d ≤ 500 kg

4. Measurement range

(1)

The minimum capacity shall not be less than 1 t, and not greater than the

value of the result of the minimum wagon weight divided by the number of

partial weighings.

The minimum wagon weight shall not be less than 50 d.

5. Performance under influence factor and electromagnetic disturbance

(1)

The MPE due to an influence factor shall be as specified in Table 11.

Table 11

Load (m) in verification scale intervals (d)

MPE

0 < m ≤ 500

± 0,5 d

500 < m ≤ 2 000

± 1,0 d

2 000 < m ≤ 10 000

± 1,5 d

The critical change value due to a disturbance is one scale interval.

(1) When placing their measuring instruments on the Obligations of

market and, or putting them into use, manufacturers shall ensure that manufacturers.

they have been designed and manufactured in accordance with the

essential requirements set out in Schedule I and in the relevant

instrument-specific Schedules.

(2) Manufacturers shall draw up the technical documentation

referred to in regulation 10 and carry out the relevant conformity

assessment procedure referred to in regulation 17 or have it carried

out.

TAXIMETERS (MI-007)

The relevant requirements of Schedule I, the specific requirements of this

Schedule and the conformity assessment procedures listed in this Schedule

apply to taximeters.

DEFINITIONS

Taximeter

A device that works together with a signal generator ( * ) to make a measuring

instrument.

This device measures duration, calculates distance on the basis of a signal

delivered by the distance signal generator. Additionally, it calculates and

displays the fare to be paid for a trip on the basis of the calculated distance

and/or the measured duration of the trip.

Fare

*The distance signal generator is outside the scope of this regulation.

The total amount of money due for a trip based on a fixed initial hire fee and/

or the length and/or the duration of the trip. The fare does not include a

supplement charged for extra services.

Cross-over speed

The speed value found by division of a time tariff value by a distance tariff

value.

Normal calculation mode S (single application of tariff)

Fare calculation based on application of the time tariff below the cross-over

speed and application of the distance tariff above the cross-over speed.

Normal calculation mode D (double application of tariff)

Fare calculation based on simultaneous application of time tariff and distance

tariff over the whole trip.

Operating position

The different modes in which a taximeter fulfils the different parts of its

functioning. The operating positions are distinguished by the following

indications

‘For

: The operating position in which the fare calculation is disabled

Hire’

‘Hired’

: The operating position in which the fare calculation takes place

on the basis of a possible initial charge and a tariff for distance

travelled and/or time of the trip

‘Stopped’ : The operating position in which the fare due for the trip is

indicated and at least the fare calculation based on time is

disabled.

DESIGN REQUIREMENTS

1. The taximeter shall be designed to calculate the distance and to measure the

duration of a trip.

2. The taximeter shall be designed to calculate and display the fare,

incrementing in steps equal to the resolution fixed by MCCAA in the

operation position ‘Hired’. The taximeter shall also be designed to display the

final value for the trip in the operating position ‘Stopped’.

3. A taximeter shall be able to apply the normal calculation modes S and D. It

shall be possible to choose between these calculation modes by a secured

setting.

4. A taximeter shall be able to supply the following data through an appropriate

secured interface(s)

-

operation position: ‘For Hire’, ‘Hired’ or ‘Stopped’;

-

totaliser data according to point 15.1;

-

general information: constant of the distance signal generator, date of

securing, taxi identifier, real time, identification of the tariff;

-

fare information for a trip: total charged, fare, calculation of the fare,

supplement charge, date, start time, finish time, distance travelled;

-

tariff(s) information: parameters of tariff(s).

National legislation may require certain devices to be connected to the

interface(s) of a taximeter. Where such a device is required; it shall be

possible, by secured setting, to inhibit automatically the operation of the

taximeter for reasons of the non-presence or improper functioning of the

required device.

5. If relevant, it shall be possible to adjust a taximeter for the constant of the

distance signal generator to which it is to be connected and to secure the

adjustment.

6. RATED OPERATING CONDITIONS

(1)

The mechanical environment class that applies is M3.

(2)

The manufacturer shall specify the rated operating conditions for the

instrument, in particular

-

a minimum temperature range of 80°C for the climatic environment;

-

the limits of the DC power supply for which the instrument has been

designed. MAXIMUM PERMISSIBLE ERRORS (MPEs)

7. The MPE, excluding any errors due to application of the taximeter in a taxi,

are

-

For the time elapsed: ± 0,1%

minimum value of mpe: 0,2 s;

-

For the distance travelled: ± 0,2%

minimum value of mpe: 4 m;

-

For the calculation of the fare: ± 0,1%

minimum, including rounding: corresponding to the least significant digit of

the fare indication. PERMISSIBLE EFFECT OF DISTURBANCES

8. Electromagnetic immunity

(1)

The electromagnetic class that applies is E3.

(2)

The MPE laid down in point 7 shall also be respected in the presence of an

electromagnetic disturbance. POWER SUPPLY FAILURE

9. In case of a reduction of the voltage supply to a value below the lower

operating limit as specified by the manufacturer, the taximeter shall

-

continue to work correctly or resume its correct functioning without

loss of data available before the voltage drop if the voltage drop is

temporary, i.e. due to restarting the engine;

-

abort an existing measurement and return to the position ‘For Hire’ if

the voltage drop is for a longer period.

OTHER REQUIREMENTS

10. The conditions for the compatibility between the taximeter and the distance

signal generator shall be specified by the manufacturer of the taximeter.

11. If there is a supplement charge for an extra service, entered by the driver on

manual command, this shall be excluded from the fare displayed. However,

in that case a taximeter may display temporarily the value of the fare

including the supplementary charge.

12. If the fare is calculated according to calculation mode D a taximeter may

have an additional display mode in which only the total distance and duration

of the trip are displayed in real time.

13. All values displayed for the passenger shall be suitably identified. These

values as well as their identification shall be clearly readable under daylight

and night conditions.

14. (1)

If the fare to be paid or the measures to be taken against fraudulent use

can be affected by the choice of functionality from a pre-programmed

setting or by free data setting, it shall be possible to secure the

instrument settings and data entered.

(2)

The securing possibilities available in a taximeter shall be such that

separate securing of the settings is possible.

(3)

The provisions in point 8.3 of Schedule I apply also to the tariffs.

15. (1)

A taximeter shall be fitted with non-resettable totalisers for all of the

following values

-

The total distance travelled by the taxi;

-

The total distance travelled when hired;

-

The total number of hirings;

-

The total amount of money charged as supplements;

-

The total amount of money charged as fare.

The totalised values shall include the values saved according to point 9

under conditions of loss of power supply.

(2)

If disconnected from power, a taximeter shall allow the totalised values

to be stored for one year for the purpose of reading out the values from

the taximeter to another medium.

(3)

Adequate measures shall be taken to prevent the display of totalised

values from being used to deceive passengers.

16. Automatic change of tariffs is allowed due to the

-

distance of the trip;

-

duration of the trip;

-

time of the day;

-

date;

-

day of the week.

17. If properties of the taxi are important for the correctness of the taximeter, the

taximeter shall provide means to secure the connection of the taximeter to the

taxi in which it is installed.

18. For the purpose of testing after installation, the taximeter shall be equipped

with the possibility to test separately the accuracy of time and distance

measurement and the accuracy of the calculation.

19. A taximeter and its installation instructions specified by the manufacturer

shall be such that, if installed according to the manufacturer’s instructions,

fraudulent alterations of the measurement signal representing the distance

travelled are sufficiently excluded.

20. The general essential requirement dealing with fraudulent use shall be

fulfilled in such a way that the interests of the customer, the driver, the

driver’s employer and the fiscal authorities are protected.

21. A taximeter shall be designed so that it can respect the MPEs without

adjustment during a period of one year of normal use.

22. The taximeter shall be equipped with a real-timeclock by means of which the

time of the day and the date are kept, one or both can be used for automatic

change of tariffs. The requirements for the real-time clock are

-

the timekeeping shall have an accuracy of 0,02%;

-

the correction possibility of the clock shall be not more than 2 minutes

per week. Correction for summer and wintertime shall be performed

automatically;

-

correction, automatic or manually, during a trip shall be prevented.

23. The values of distance travelled and time elapsed, when displayed or printed

in accordance with this regulations, shall use the following units

Distance travelled

-

kilometres;

-

miles, in those Member States to which Article (1)(b) of Regulation

80/181/EEC applies.

Time elapsed

-

seconds, minutes or hours, as may be suitable; keeping in mind the

necessary resolution and the need to prevent misunderstandings.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 17 that the

manufacturer can choose between are: B + F or B + D or H1.

(1) Where compliance of a measuring instrument with Compliance of a

the applicable requirements of these regulations has been measuring

instrument.

demonstrated by that conformity assessment procedure,

manufacturers shall draw up an EU declaration of conformity and

affix the CE marking and the supplementary metrology marking.

(2) Manufacturers shall keep the technical documentation and

the EU declaration of conformity for ten years after the measuring

instrument has been placed on the market.

(3) Manufacturers shall ensure that procedures are in place for

series production to remain in conformity with these regulations.

Changes in measuring instrument design or characteristics and

changes in the harmonised standards, normative documents or in

other technical specifications by reference to which conformity of a

measuring instrument is declared shall be adequately taken into

account.

(4) When deemed appropriate with regard to the performance

of a measuring instrument, manufacturers shall carry out sample

testing of measuring instruments made available on the market,

investigate and, if necessary, keep a register of complaints, of non-

conforming measuring instruments and measuring instrument recalls,

and shall keep distributors informed of any such monitoring.

(5) Manufacturers shall ensure that measuring instruments

which they have placed on the market bear a type, batch or serial

number or other element allowing their identification, or, where the

size or nature of the measuring instrument does not allow it, that the

required information is provided in a document accompanying the

measuring instrument and on the packaging, if any, in accordance

with point 9.2 of Schedule I.

(6) Manufacturers shall indicate on the measuring instrument

their name, registered trade name or registered trade mark and the

postal address at which they can be contacted or, where that is not

possible, in a document accompanying the measuring instrument and

on the packaging, if any, in accordance with point 9.2 of Schedule I.

The address shall indicate a single point at which the manufacturer

can be contacted. The contact details shall be in at least English and,

or Maltese.

(7) Manufacturers shall ensure that the measuring instrument

which they have placed on the market is accompanied by a copy of

the EU Declaration of conformity and by instructions and information

in accordance with point 9.3 of Schedule I, in at least English and, or

Maltese. Such instructions and information, as well as any labelling,

shall be clear, understandable and intelligible.

(8) Manufacturers who consider or have reason to believe that

a measuring instrument which they have placed on the market is not

in conformity with these regulations shall immediately take the

corrective measures necessary to bring that measuring instrument into

conformity, to withdraw it or recall it, if appropriate. Furthermore,

where the measuring instrument presents a risk, manufacturers shall

immediately inform the Authority in which they made the measuring

instrument available on the market to that effect, giving details, in

particular, of the non-compliance and of any corrective measures

taken.

(9) Manufacturers shall, further to a reasoned request from the

Authority, provide it with all the information and documentation in

paper or electronic form necessary to demonstrate the conformity of

the measuring instrument with these regulations, in at least English

and, or Maltese. They shall cooperate with that authority, at its

request, on any action taken to eliminate the risks posed by measuring

instruments which they have placed on the market.

MATERIAL MEASURES (MI-008) CHAPTER I

Material measures of length

The relevant essential requirements of Schedule I, the specific requirements

of this Schedule and the conformity assessment procedures listed in this

chapter, apply to material measures of length defined below. However, the

requirement for the supply of a copy of declarations of conformity may be

interpreted as applying to a batch or consignment rather than each individual

instrument.

DEFINITIONS

Material measure An instrument comprising scale marks whose distances are

of length

given in legal units of length .

SPECIFIC REQUIREMENTS

1. Reference Conditions

(1)

For tapes of length equal to or greater than 5 metres, the maximum

permissible errors (MPEs) are to be met when a tractive force of fifty

newtons or other force values as specified by the manufacturer and marked on

the tape accordingly, or in the case of rigid or semi-rigid measures no tractive

force is needed, is applied.

(2)

The reference temperature is 20°C unless otherwise specified by the

manufacturer and marked on the measure accordingly.

MPEs

2. The MPE, positive or negative in mm, between two non-consecutive scale

marks is (a + bL), where

-

L is the value of the length rounded up to the next whole metre; and

-

a and b are given in Table 1 below.

When a terminal interval is bounded by a surface, the MPE for any distance

beginning at this point is increased by the value c given in Table 1.

Table 1

Accuracy Class

a (mm)

b

c (mm)

0,1

0,1

0,1

0,3

0,2

0,2

0,6

0,4

0,3

D - special class for dipping tapes (1) 1,5

zero

zero

Up to and including 30 m (2)

S - special class for tank strapping 1,5

zero

zero

tapes

For each 30 m length when the tape

is supported on a flat surface

(1) Applies to the tape/dip weight combinations.

(2) If the nominal tape length exceeds 30 m, an additional mpe of 0,75 mm shall be

permitted for each 30 m of tape length.

Dip tapes may also be of Classes I or II in which case for any length between

two scale marks, one of which is on the sinker and the other on the tape, the

MPE is ± 0,6 mm when application of the formula gives a value of less than

0,6 mm.

The MPE for the length between consecutive scale marks, and the maximum

permissible difference between two consecutive intervals, are given in Table

2 below.

Table 2

Length i of the

MPE or difference in millimetres according to

interval

accuracy class

I

II

III

i ≤ 1 mm

0,1

0,2

0,3

1 mm < i ≤ 1 cm

0,2

0,4

0,6

Where a rule is of the folding type, the jointing shall be such as not to cause

any errors, supplementary to those above, exceeding: 0,3 mm for Class II,

and 0,5 mm for Class III.

3. Materials

(1)

Materials used for material measures shall be such that length variations due

to temperature excursions up to ± 8°C about the reference temperature do not

exceed the MPE. This does not apply to Class S and Class D measures where

the manufacturer intends that thermal expansion corrections shall be applied

to observe readings where necessary.

(2)

Measures made from material whose dimensions may alter materially when

subjected to a wide range of relative humidity, may only be included in

Classes II or III.

4. Markings

The nominal value shall be marked on the measure. Millimetre scales shall be

numbered every centimetre and measures with a scale interval greater than 2

cm shall have all scale marks numbered.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 17 that the

manufacturer can choose between are: F1 or D1 or B + D or H or G.

CHAPTER II

Capacity serving measures

The relevant essential requirements of Schedule I, and the specific

requirements and the conformity assessment procedures listed in this chapter,

apply to capacity serving measures defined below. However, the requirement

for the supply of a copy of declarations of conformity may be interpreted as

applying to a batch or consignment rather than each individual instrument.

Also, the requirement for the instrument to bear information in respect of its

accuracy shall not apply.

DEFINITIONS

Capacity serving

A capacity measure (such as a drinking glass, jug or

measure

thimble measure) designed to determine a specified

volume of a liquid (other than a pharmaceutical

product) which is sold for immediate consumption.

Line measure

A capacity serving measure marked with a line to

indicate nominal capacity.

Brim measure

A capacity serving measure for which the internal

volume is equal to the nominal capacity.

Transfer measure

A capacity serving measure from which it is intended

that the liquid is decanted prior to consumption.

Capacity

The capacity is the internal volume for brim measures

or internal volume to a filling mark for line measures.

SPECIFIC REQUIREMENTS

1. Reference Conditions

(1)

Temperature: the reference temperature for measurement of capacity is 20°C.

(2)

Position for correct indication: free standing on a level surface.

2. MPEs

Table 1

Line

Brim

Transfer

< 100 ml

± 2 ml

– 0

+ 4 ml

≥ 100 ml

± 3%

– 0

+ 6%

Serving

measures

< 200 ml

± 5%

– 0

+ 10%

≥ 200 ml

± (5 ml + 2,5%)

– 0

+ 10 ml +

5%

3. Materials

Capacity serving measures shall be made of material which is sufficiently

rigid and dimensionally stable to maintain capacity within the MPE.

4. Shape

(1)

Transfer measures shall be designed so that a change of contents equal to the

MPE causes a change in level of at least 2 mm at the brim or filling mark.

(2)

Transfer measures shall be designed so that the complete discharge of the

liquid being measured will not be impeded.

5. Marking

(1)

The nominal capacity declared shall be clearly and indelibly marked on the

measure.

(2)

Capacity serving measures may also be marked with up to three clearly

distinguishable capacities, none of which shall lead to confusion one to the

other.

(3)

All filling marks shall be sufficiently clear and durable to ensure that MPEs

are not exceeded in use.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 17 that the

manufacturer can choose between are: A2 or F1 or D1 or E1 or B + E or B +

D or H.

(1) A manufacturer may, by a written mandate, appoint Authorised

representatives.

an authorised representative.

(2) The obligations laid down in regulation 9(1) and the

obligation to draw up technical documentation referred to in

regulation 9(2) shall not form part of the authorised representative’s

mandate.

(3) An authorised representative shall perform the tasks

specified in the mandate received from the manufacturer. The

mandate shall allow the authorised representative to do at least the

following

(a)

keep the EU declaration of conformity and the

technical documentation at the disposal of the Authority for ten

years after the measuring instrument has been placed on the

market;

(b) further to a reasoned request from a competent

national authority, provide that authority with all the

information and documentation necessary to demonstrate the

conformity of a measuring instrument;

(c)

cooperate with the competent national authorities, at

their request, on any action taken to eliminate the risks posed by

measuring instruments covered by their mandate.

DIMENSIONAL MEASURING INSTRUMENTS (MI-009)

The relevant essential requirements of Schedule I, the specific requirements

of this Schedule and the conformity assessment procedures listed in this

Schedule, apply to dimensional measuring instruments of the types defined

A length measuring instrument serves for the

determination of the length of rope- type materials (e.g.

textiles, bands, cables) during feed motion of the

product to be measured.

An area measuring instrument serves for the

determination of the area of irregular shaped objects,

e.g. for leather.

A multi-dimensional measuring instrument serves for

the determination of the edge length (length, height,

width) of the smallest enclosing rectangular parallel

piped of a product.

CHAPTER I

Requirements common to all dimensional measuring instruments

Electromagnetic immunity

1. The effect of an electromagnetic disturbance on a dimensional measuring

instrument shall be such that

the change in measurement result is no greater than the critical change

value as defined in point 2; or

it is impossible to perform any measurement; or

there are momentary variations in the measurement result that cannot

be interpreted, memorised or transmitted as a measuring result; or

there are variations in the measurement result severe enough to be

noticed by all those interested in the measurement result.

2. The critical change value is equal to one scale interval.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 17 that the

manufacturer can choose between are: For mechanical or electromechanical

F1 or E1 or D1 or B + F or B + E or B + D or H or H1 or G. For electronic

instruments or instruments containing software

B + F or B + D or H1 or G.

CHAPTER II

Length measuring instruments

Characteristics of the product to be measured

1. Textiles are characterised by the characteristic factor K. This factor takes the

stretchability and force per unit area of the product measured into account

and is defined by the following formula

ε · (G A + 2,2 N/m 2 ), where

=

ε is the relative elongation of a cloth specimen 1 m wide at a tensile

force of 10 N,

G A is the weight force per unit area of a cloth specimen in N/m 2 .

2. Operating conditions

(1)

Range

Dimensions and K-factor, where applicable, within the range specified by the

manufacturer for the instrument. The ranges of K-factor are given in Table 1

Table 1

Group

Range of K

Product

low stretchability

0 < K < 2 × 10 –2 N/m 2

2 × 10 –2 N/m 2 < K < 8 × 10 –2 N/m 2

medium stretchability

8 × 10 –2 N/m 2 < K < 24 × 10 –2 N/m 2

high stretchability

very high stretchability

24 × 10 –2 N/m 2 < K

(2)

Where the measured object is not transported by the measuring instrument,

its speed must be within the range specified by the manufacturer for the

instrument.

(3)

If the measurement result depends on the thickness, the surface condition and

the kind of delivery (e.g. from a big roll or from a pile), corresponding

limitations are specified by the manufacturer.

MPEs

Instrument

Table 2

Accuracy class

MPE

I

0,125%, but not less than 0,005 Lm

II

0,25%, but not less than 0,01 Lm

III

0,5%, but not less than 0,02 Lm

Where Lm is the minimum measurable length, that is to say the smallest

length specified by the manufacturer for which the instrument is intended to

be used.

The true length value of the different types of materials shall be measured

using suitable instruments (e.g. tapes of length). Thereby, the material which

is going to be measured shall be laid out on a suitable underlay (e.g. a suitable

table) straight and unstretched.

Other requirements

The instruments must ensure that the product is measured unstretched

according to the intended stretch ability for which the instrument is designed.

CHAPTER III

Area measuring instruments

1. Operating conditions

(1)

Range

Dimensions within the range specified by the manufacturer for the

instrument.

(2)

Condition of the product

The manufacturer shall specify the limitations of the instruments due to the

speed, and thickness of the surface conditions if relevant, of the product.

MPEs

2. Instrument

The MPE is 1,0%, but not less than 1 dm 2 .

Other requirements

3. Presentation of the product

In the case of pulling back or stopping the product, it shall not be possible to

have an error of measurement or the display must be blanked.

4. Scale interval

The instruments must have a scale interval of 1,0 dm 2 . In addition, it must be

possible to have a scale interval of 0,1 dm 2 for testing purposes.

CHAPTER IV

Multidimensional measuring instruments

Operating conditions

Range

Dimensions within the range specified by the manufacturer for the

instrument.

Minimum dimension

The lower limit of the minimum dimension for all values of the scale interval

is given in Table 1.

Table 1

Scale interval (d)

Minimum dimension (min) (lower limit)

d ≤ 2 cm

10 d

2 cm < d ≤ 10 cm

20 d

10 cm < d

50 d

Speed of the product

The speed must be within the range specified by the manufacturer for the

instrument.

MPE

2. Instrument

The MPE is ± 1,0 d.

(1) Importers shall place only compliant measuring Obligations of

importers.

instruments on the market.

(2) Before placing a measuring instrument on the market and,

or putting a measuring instrument into use importers shall ensure that

the appropriate conformity assessment procedure referred to in

regulation 17 has been carried out by the manufacturer. They shall

ensure that the manufacturer has drawn up the technical

documentation, that the measuring instrument bears the CE marking

and the supplementary metrology marking and is accompanied by a

copy of the EU declaration of conformity and the required

documents, and that the manufacturer has complied with the

requirements set out in regulation 10(5) and (6).

(3) Where an importer considers or has reason to believe that a

measuring instrument is not in conformity with the essential

requirements set out in Schedule I and in the relevant instrument-

specific Schedules, he shall not place the measuring instrument on the

market or put it into use until it has been brought into conformity.

Furthermore, where the measuring instrument presents a risk, the

importer shall inform the manufacturer and the Authority to that

effect.

(4) Importers shall indicate on the measuring instrument their

name, registered trade name or registered trade mark and the postal

address at which they can be contacted or, where that is not possible,

in a document accompanying the measuring instrument and on its

packaging, if any, in accordance with point 9.2 of Schedule I. The

contact details shall be in at least English and, or Maltese.

(5) Importers shall ensure that the measuring instrument is

accompanied by instructions and information in accordance with

point 9.3 of Schedule I, in at least English and, or Maltese.

(6) Importers shall ensure that, while a measuring instrument

is under their responsibility, its storage or transport conditions do not

jeopardise its compliance with the essential requirements set out in

Schedule I and in the relevant instrument-specific Schedules.

(7) When deemed appropriate with regard to the performance

of a measuring instrument, importers shall carry out sample testing of

measuring instruments made available on the market, investigate,

and, if necessary, keep a register of complaints, of non-conforming

measuring instruments and measuring instrument recalls, and shall

keep distributors informed of any such monitoring.

(8) Importers who consider or have reason to believe that a

measuring instrument which they have placed on the market is not in

conformity with these regulations shall immediately take the

corrective measures necessary to bring that measuring instrument into

conformity, to withdraw it or recall it, if appropriate. Furthermore,

where the measuring instrument presents a risk, importers shall

immediately inform the Authority in which they made the measuring

instrument available on the market to that effect, giving details, in

particular, of the non-compliance and of any corrective measures

taken.

(9) Importers shall, for ten years after the measuring

instrument has been placed on the market keep a copy of the EU

declaration of conformity at the disposal of the Authority and ensure

that the technical documentation can be made available to those

authorities, upon request.

(10) Importers shall, further to a reasoned request from the

Authority, provide it with all the information and documentation in

paper or electronic form necessary to demonstrate the conformity of a

measuring instrument in at least English and, or Maltese. They shall

cooperate with the Authority, at its request, on any action taken to

eliminate the risks posed by measuring instruments which they have

placed on the market.

EXHAUST GAS ANALYSERS (MI-010)

The relevant requirements of Schedule I, the specific requirements of this

Schedule and the conformity assessment procedures listed in this Schedule,

apply to exhaust gas analysers defined below intended for inspection and

professional maintenance of motor vehicles in use.

An exhaust gas analyser is a measuring instrument that

serves to determine the volume fractions of specified

components of the exhaust gas of a motor vehicle

engine with spark ignition at the moisture level of the

sample analysed.

These gas components are carbon monoxide (CO),

carbon dioxide (CO 2 ), oxygen (O 2 ) and hydrocarbons

(HC).

The content of hydrocarbons has to be expressed as

concentration of n-hexane (C 6 H 14 ), measured with

near-infrared absorption techniques.

The volume fractions of the gas components are

expressed as a percentage (% vol) for CO, CO 2 and O 2

and in parts per million (ppm vol) for HC.

Moreover, an exhaust gas analyser calculates the

lambda value from the volume fractions of the

components of the exhaust gas.

Lambda is a dimensionless value representative of the

burning efficiency of an engine in terms of air/fuel ratio

in the exhaust gases. It is determined with a reference

standardised formula.

SPECIFIC REQUIREMENTS

Two classes (0 and I) are being defined for exhaust gas analysers. The

relevant minimum measuring ranges for these classes are shown in Table 1.

Table 1

Classes and measuring ranges

Parameter

Classes 0 and I

CO fraction

from 0 to 5% vol

CO 2 fraction

from 0 to 16% vol

HC fraction

from 0 to 2 000 ppm vol

O 2 fraction

from 0 to 21% vol

λ

from 0,8 to 1,2

Rated operating conditions

2. The values of the operating conditions shall be specified by the manufacturer

as follows

(1)

For the climatic and mechanical influence quantities

-

a minimum temperature range of 35°C for the climatic environment;

-

the mechanical environment class that applies is M1.

For the electrical power influence quantities

-

the voltage and frequency range for the AC voltage supply;

-

the limits of the DC voltage supply.

(3)

For the ambient pressure

-

the minimum and the maximum values of the ambient pressure are for

both classes: pmin ≤ 860 hPa, Pmax ≥ 1 060 hPa.

Maximum permissible errors (MPEs)

3. The MPEs are defined as follows

(1)

For each of the fractions measured, the maximum error value permitted under

rated operating conditions according to point 1.1 of Schedule I is the greater

of the two values shown in Table 2. Absolute values are expressed in% vol or

ppm vol, percentage values are percent of the true value.

Table 2

MPEs

Parameter

Class 0

Class I

CO fraction

± 0,03% vol

± 0,06% vol

± 5%

± 5%

CO 2 fraction

± 0,5% vol

± 0,5% vol

±5%

± 5%

HC fraction

± 10 ppm

± 12 ppm vol

vol

± 5%

± 5%

O2 fraction

± 0,1% vol

± 0,1% vol

± 5%

± 5%

(2)

The MPE on lambda calculation is 0,3%. The conventional true value is

calculated according to the formula set out in point 5.3.7.3 of Regulation No

83 of the Economic Commission for Europe of the United Nations (UN/ECE)

(1).

For this purpose, the values displayed by the instrument are used for

calculation.

Permissible effect of disturbances

4. For each of the volume fractions measured by the instrument, the critical

change value is equal to the MPE for the parameter concerned.

5. The effect of an electromagnetic disturbance shall be such that

-

either the change in the measurement result is not greater than the

critical change value laid down in point 4;

-

or the presentation of the measurement result is such that it cannot be

taken for a valid result.

Other requirements

The resolution shall be equal to or of one order of magnitude higher than the

values shown in Table 3.

Table 3

Resolution

CO

CO 2

HC

Class 0 and

0.01% vol

0.1% vol

(15)

1 ppm vol

Class 1

(1)

0,01% vol for measurand values below or equal to 4% vol, otherwise 0,1%

vol.

The lambda value shall be displayed with a resolution of 0,001. see OJ L42,

15.2.2012, p.1

7. The standard deviation of 20 measurements shall not be greater than one third

of the modulus of the MPE for each applicable gas volume fraction.

8. For measuring CO, CO2 and HC, the instrument, including the specified gas

handling system, must indicate 95% of the final value as determined with

calibration gases within 15 seconds after changing from a gas with zero

content, e.g. fresh air. For measuring O2, the instrument under similar

conditions must indicate a value differing less than 0,1% vol from zero within

60 seconds after changing from fresh air to an oxygen-free gas.

9. The components in the exhaust gas, other than the components whose values

are subject to the measurement, shall not affect the measurement results by

more than the half of the modulus of the MPEs when those components are

present in the following maximum volume fractions

6% vol CO,

16% vol CO2,

10% vol O2,

5% vol H2,

0,3% vol NO,

2 000 ppm vol HC (as n-hexane), water vapor up to saturation.

10. An exhaust gas analyser shall have an adjustment facility that provides

operations for zero-setting, gas calibration and internal adjustment. The

adjustment facility for zero-setting and internal adjustment shall be

automatic.

11. For automatic or semi-automatic adjustment facilities, the instrument shall be

unable to make a measurement as long as the adjustments have not been

made.

12. An exhaust gas analyser shall detect hydrocarbon residues in the gas handling

system. It shall not be possible to carry out a measurement if the hydrocarbon

residues, present before any measurement, exceed 20 ppm vol.

13. An exhaust gas analyser shall have a device for automatically recognising

any malfunctioning of the sensor of the oxygen channel due to wear or a

break in the connecting line.

14. If the exhaust gas analyser is capable to operate with different fuels (e.g.

petrol or liquefied gas), there shall be the possibility to select the suitable

coefficients for the Lambda calculation without ambiguity concerning the

appropriate formula.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred to in Article 17 that the

manufacturer can choose between are: B + F or B + D or H1.

(1) When making a measuring instrument available on Obligations of

the market and, or putting it into use, distributors shall act with due distributors.

care in relation to the requirements of these regulations.

(2) Before making a measuring instrument available on the

market and, or putting a measuring instrument into use distributors

shall verify that the measuring instrument bears the CE marking and

the supplementary metrology marking, that it is accompanied by the

EU declaration of conformity, by the required documents and by

instructions and information in accordance with point 9.3 of Schedule

I, in at least English and, or Maltese, or put into use, and that the

manufacturer and the importer have complied with the requirements

set out in regulation 10(5) and (6) and regulation 12(3) respectively.

(3) Where a distributor considers or has reason to believe that

a measuring instrument is not in conformity with the essential

requirements set out in Schedule I and in the relevant instrument-

specific Schedules, he shall not make the measuring instrument

available on the market or put it into use, until it has been brought

into conformity. Furthermore, where the measuring instrument

presents a risk, the distributor shall inform the manufacturer or the

importer to that effect as well as the Authority.

(4) Distributors shall ensure that, while a measuring

instrument is under their responsibility, its storage or transport

conditions do not jeopardise its compliance with the essential

requirements set out in Schedule I and in the relevant instrument-

specific Schedules.

(5) Distributors who consider or have reason to believe that a

measuring instrument which they have made available on the market

or put into use is not in conformity with these regulations shall make

sure that the corrective measures necessary to bring that measuring

instrument into conformity, to withdraw it or recall it, if appropriate,

are taken. Furthermore, where the measuring instrument presents a

risk, distributors shall immediately inform the competent national

authorities of the Member States in which they made the measuring

instrument available on the market to that effect, giving details, in

particular, of the non-compliance and of any corrective measures

taken.

(5) Distributors shall, further to a reasoned request from the

Authority, provide it with all the information and documentation in

paper or electronic form necessary to demonstrate the conformity of a

measuring instrument. They shall cooperate with the Authority, at its

request, on any action taken to eliminate the risks posed by measuring

instruments which they have made available on the market.

EU DECLARATION OF CONFORMITY (No XXXX) ( * )

1. Instrument model/Instrument (product, type, batch or serial number)

2. Name and address of the manufacturer and, where applicable, his authorised

representative

3. This declaration of conformity is issued under the sole responsibility of the

manufacturer.

4. Object of the declaration (identification of instrument allowing traceability; it

may, where necessary for the identification of the instrument, include an

image)

5. The object of the declaration described above is in conformity with the

relevant Union harmonisation legislation

6. References to the relevant harmonised standards or normative documents

used or references to the other technical specifications in relation to which

conformity is declared

7. Where applicable, the notified body … (name, number) performed …

(description of intervention) and issued the certificate

8. Additional information

* It is optional for the manufacturer to assign a number to the declaration of conformity.

Signed for and on behalf of

(place and date of issue)

(name, function)

(signature)

B

€5.94

An importer or distributor shall be considered a

manufacturer for the purposes of these regulations and he shall be

subject to the obligations of the manufacturer under regulation 9,

where he places a measuring instrument on the market under his name

or trade mark or modifies a measuring instrument already placed on

the market in such a way that compliance with these regulations may

be affected.

Economic operators shall, on request, identify the

following to the Authority

(a)

any economic operator who has supplied them with

a measuring instrument;

(b) any economic operator to whom they have supplied

a measuring instrument.

(c)

economic operators shall be able to present the

information referred to in paragraph (a) for ten years after they

have been supplied with the measuring instrument and for ten

years after they have supplied the measuring instrument.

(1) Measuring instruments which are in conformity with

harmonised standards or parts thereof shall be presumed to be in

conformity with the essential requirements set out in Schedule I and

in the relevant instrument-specific Schedules covered by those

standards or parts thereof.

(2) Measuring instruments which are in conformity with parts

of normative documents shall be presumed to be in conformity with

the essential requirements set out in Schedule I and in the relevant

instrument-specific Schedules covered by those parts of normative

documents.

(3) A manufacturer may choose to use any technical solution

that complies with the essential requirements set out in Schedule I

and in the relevant instrument-specific Schedules. In addition, to

benefit from the presumption of conformity, the manufacturer must

correctly apply solutions mentioned either in the relevant harmonised

standards or in the normative documents referred to in sub-

regulations (1) and (2).

(4) Compliance shall be presumed with the appropriate tests

mentioned in regulation 18(3) if the corresponding test programme

has been performed in accordance with the relevant documents

mentioned in sub-regulations (1), (2) and (3) and if the test results

ensure compliance with the essential requirements.

(1) Conformity assessment of a measuring instrument Conformity

with the applicable essential requirements shall be carried out by the assessment

procedures.

application, at the choice of the manufacturer, of one of the

conformity assessment procedures listed in the relevant instrument-

specific Schedules.

(2) The conformity assessment procedures are set out in

Schedule II. Records and correspondence relating to conformity

assessment procedures shall be drawn up in the at least English

language where the notified body carrying out the conformity

assessment procedures is established, or in a language accepted by

that body.

(1) The technical documentation shall render the design, Technical

manufacture and operation of the measuring instrument intelligible documentation.

and shall permit an assessment of its conformity with the applicable

requirements of these regulations.

(2) The technical documentation shall be sufficiently detailed

to ensure compliance with the following requirements

(a)

the definition of the metrological characteristics;

(b) the reproducibility of the metrological performances

of produced measuring instruments when properly adjusted

using appropriate intended means;

(c)

the integrity of the measuring instrument.

(3) The technical documentation shall insofar as relevant for

assessment and identification of the type and, or the measuring

instruments include the following information

(a)

a general description of the measuring instrument;

(b) conceptual design and manufacturing drawings and

plans of components, sub-assemblies, circuits, etc.;

(c)

manufacturing procedures to ensure consistent

production;

(d) if applicable, a description of the electronic devices

with drawings, diagrams, flow diagrams of the logic and general

software information explaining their characteristics and

operations;

(e)

descriptions and explanations necessary for the

understanding of the information referred to in paragraphs (b),

(c) and (d), including the operation of the measuring instrument;

(f)

a list of the harmonised standards and, or normative

documents referred to in regulation, applied in full or in part, the

references of which have been published in the Official Journal

of the European Union;

(g) descriptions of the solutions adopted to meet the

essential requirements where the harmonised standards and/or

normative documents referred to in regulation 16 have not been

applied, including a list of other relevant technical

specifications applied;

(h)

results of design calculations, examinations, etc.;

(i)

the appropriate test results, where necessary, to

demonstrate that the type and, or the measuring instruments

comply with the following

(i) the requirements of these regulations under

declared rated operating conditions and under specified

environmental disturbances; and

(ii) the durability specifications for gas-, water-,

thermal energy-meters as well as for liquids other than

water;

(j)

the EU-type examination certificates or EU design

examination certificates in respect of measuring instruments

containing parts identical to those in the design.

(4) The manufacturer shall specify where seals and markings

have been applied.

(5) The manufacturer shall indicate the conditions for

compatibility with interfaces and sub-assemblies, where relevant.

(1) The EU declaration of conformity shall state that the EU declaration

fulfilment of the essential requirements set out in Schedule I and in of conformity.

the relevant instrument-specific Schedules has been demonstrated.

(2) The EU declaration of conformity shall have the model

structure set out in Schedule XIII, shall contain the elements specified

in the relevant modules set out in Schedule II and shall be

continuously updated. It shall be translated in at least English and, or

Maltese.

(3) Where a measuring instrument is subject to more than one

Union act requiring an EU declaration of conformity, a single EU

declaration of conformity shall be drawn up in respect of all such

Union acts. That declaration shall contain the identification of the

Union acts concerned, including their publication references.

(4) By drawing up the EU declaration of conformity, the

manufacturer shall assume responsibility for the compliance of the

measuring instrument with the requirements laid down in these

regulations.

The conformity of a measuring instrument with these Conformity

regulations shall be indicated by the presence on it of the CE marking marking.

and the supplementary metrology marking as specified in regulation

21. (1) The CE marking shall be subject to the general General

principles set out in regulation 30 of Regulation (EC) No 765/2008. principles

CE marking and

of the

supplementary

(2) The supplementary metrology marking shall consist of the

metrology

capital letter ‘M’ and the last two digits of the year of its affixing,

marking.

surrounded by a rectangle. The height of the rectangle shall be equal

to the height of the CE marking.

(3) The general principles set out in regulation 30 of

Regulation (EC) No 765/2008 shall apply, mutatis mutandis, to the

supplementary metrology marking.

(1) The CE marking and the supplementary metrology Rules and

marking shall be affixed visibly, legibly and indelibly to the conditions

affixing the CE

measuring instrument or to its data plate. Where that is not possible or marking

supplementary

not warranted on account of the nature of the measuring instrument, metrology

they shall be affixed to the accompanying documents and to the marking.

packaging, if any.

(2) When a measuring instrument consists of a set of devices,

not being sub-assemblies, operating together, the CE marking and the

supplementary metrology marking shall be affixed on the

instrument’s main device.

(3) The CE marking and the supplementary metrology

marking shall be affixed before the measuring instrument is placed on

the market.

(4) The CE marking and the supplementary metrology

marking may be affixed to the instrument during the fabrication

process, if justified.

(5) The supplementary metrology marking shall immediately

follow the CE marking.

(6) The CE marking and the supplementary metrology

marking shall be followed by the identification number of the notified

body, where that body is involved in the production control phase as

set out in Schedule II.

(7) The identification number of the notified body shall be

affixed by the body itself or, under its instructions, by the

manufacturer or his authorised representative.

(8) The identification number of the notified body concerned

shall be indelible or self destructive upon removal.

(9) The CE marking, the supplementary metrology marking

and, where applicable, the identification number of the notified body

may be followed by any other mark indicating a special risk or use.

(10) The Authority shall build upon existing mechanisms to

ensure correct application of the regime governing the CE marking

and shall take appropriate action in the event of improper use of that

marking.

The Authority shall notify the Commission and the other

Member States of bodies authorised to carry out third-party

conformity assessment tasks under these regulations.

(1) The Authority shall be responsible for setting up and

carrying out the necessary procedures for the assessment and

notification of conformity assessment bodies and the monitoring of

notified bodies, including compliance with the provisions of

regulation 29.

(2) The assessment and monitoring referred to in regulation

21(1) shall be carried out by the National Accreditation Board

(Malta).

(1)

The Authority shall be

Requirements

relating to

notifying

(a)

established in such a way that no conflict of interest

authorities.

with conformity assessment bodies occurs;

(b) organised and operated so as to safeguard the

objectivity and impartiality of its activities;

(c)

be organised in such a way that each decision

relating to notification of a conformity assessment body is taken

by competent persons different from those who carried out the

assessment.

(d) not offer or provide any activities that conformity

assessment bodies perform or consultancy services on a

commercial or competitive basis;

(e)

safeguard the confidentiality of the information it

obtains

(f)

have a sufficient number of competent personnel at

its disposal for the proper performance of its tasks.

The Authority shall inform the Commission of their Information

procedures for the assessment and notification of conformity obligation

notifying

assessment bodies and the monitoring of notified bodies, and of any authorities.

changes thereto.

(1) For the purposes of notification, a conformity Requirements

assessment body shall meet the requirements laid down in sub- relating

notified bodies.

regulations (2) to (11).

(2) A conformity assessment body shall be established under

national law of Malta and have legal personality.

(3) A conformity assessment body shall be a third-party body

independent of the organisation or the measuring instrument it

assesses.

A body belonging to a business association or professional

federation representing undertakings involved in the design,

manufacturing, provision, assembly, use or maintenance of measuring

instruments which it assesses, may, on condition that its independence

and the absence of any conflict of interest are demonstrated, be

considered such a body.

(4) A conformity assessment body, its top level management

and the personnel responsible for carrying out the conformity

assessment tasks shall not be the designer, manufacturer, supplier,

installer, purchaser, owner, user or maintainer of the measuring

instruments which they assess, nor the representative of any of those

parties. This shall not preclude the use of assessed measuring

instruments that are necessary for the operations of the conformity

assessment body or the use of such measuring instruments for

personal purposes.

A conformity assessment body, its top level management and

the personnel responsible for carrying out the conformity assessment

tasks shall not be directly involved in the design, manufacture or

construction, the marketing, installation, use or maintenance of those

measuring instruments, or represent the parties engaged in those

activities. They shall not engage in any activity that may conflict with

their independence of judgement or integrity in relation to conformity

assessment activities for which they are notified. This shall in

particular apply to consultancy services.

The second paragraph does not, however, preclude the

possibility of exchanges of technical information between the

manufacturer and the body for the purposes of conformity

assessment.

Conformity assessment bodies shall ensure that the activities of

their subsidiaries or subcontractors do not affect the confidentiality,

objectivity or impartiality of their conformity assessment activities.

(5) Conformity assessment bodies and their personnel shall

carry out the conformity assessment activities with the highest degree

of professional integrity and the requisite technical competence in the

specific field and shall be free from all pressures and inducements,

particularly financial, which might influence their judgement or the

results of their conformity assessment activities, especially as regards

persons or groups of persons with an interest in the results of those

activities.

(6) A conformity assessment body shall be capable of carrying

out all the conformity assessment tasks assigned to it by Schedule II

and in relation to which it has been notified, whether those tasks are

carried out by the conformity assessment body itself or on its behalf

and under its responsibility. At all times and for each conformity

assessment procedure and each kind or category of measuring

instruments in relation to which it has been notified, a conformity

assessment body shall have at its disposal the necessary

(a)

personnel with technical knowledge and sufficient

and appropriate experience to perform the conformity

assessment tasks;

(b) descriptions of procedures in accordance with which

conformity assessment is carried out, ensuring the transparency

and the ability of reproduction of those procedures. It shall have

appropriate policies and procedures in place that distinguish

between tasks it carries out as a notified body and other

activities;

(c)

procedures for the performance of activities which

take due account of the size of an undertaking, the sector in

which it operates, its structure, the degree of complexity of the

measuring instrument technology in question and the mass or

serial nature of the production process.

A conformity assessment body shall have the means necessary

to perform the technical and administrative tasks connected with the

conformity assessment activities in an appropriate manner and shall

have access to all necessary equipment or facilities.

(7) The personnel responsible for carrying out conformity

assessment tasks shall have the following

(a)

sound technical and vocational training covering all

the conformity assessment activities in relation to which the

conformity assessment body has been notified;

(b) satisfactory knowledge of the requirements of the

assessments they carry out and adequate authority to carry out

those assessments;

(c)

appropriate knowledge and understanding of the

essential requirements set out in Schedule I and in the relevant

instrument-specific Schedules, of the applicable harmonised

standards and normative documents and of the relevant

provisions of Union harmonisation legislation and of national

legislation;

(d) the ability to draw up certificates, records and

reports demonstrating that assessments have been carried out.

(8) The impartiality of the conformity assessment bodies, their

top level management and of the personnel responsible for carrying

out the conformity assessment tasks shall be guaranteed.

The remuneration of the top level management and personnel

responsible for carrying out the conformity assessment tasks of a

conformity assessment body shall not depend on the number of

assessments carried out or on the results of those assessments.

(9) Conformity assessment bodies shall take out liability

insurance unless liability is assumed by the Government of Malta in

accordance with national law, or the Authority itself is directly

responsible for the conformity assessment.

(10) The personnel of a conformity assessment body shall

observe professional secrecy with regard to all information obtained

in carrying out their tasks under Schedule II or any provision of

national law giving effect to it, except in relation to the competent

authorities of Malta in which its activities are carried out. Proprietary

rights shall be protected.

(11) Conformity assessment bodies shall participate in, or

ensure that their personnel responsible for carrying out the

conformity assessment tasks are informed of, the relevant

standardisation activities and the activities of the notified body

coordination group established under the relevant Union

harmonisation legislation and shall apply as general guidance the

administrative decisions and documents produced as a result of the

work of that group.

Where a conformity assessment body demonstrates its

conformity with the criteria laid down in the relevant harmonised

standards or parts thereof, the references of which have been

published in the Official Journal of the European Union, it shall be

presumed to comply with the requirements set out in regulation 27 in

so far as the applicable harmonised standards cover those

requirements.

(1) Where a notified body subcontracts specific tasks

connected with conformity assessment or has recourse to a subsidiary,

it shall ensure that the subcontractor or the subsidiary meets the

requirements set out in regulation 27 and shall inform the Authority

accordingly.

(2) Notified bodies shall take full responsibility for the tasks

performed by subcontractors or subsidiaries wherever these are

established.

(3) Activities may be subcontracted or carried out by a

subsidiary only with the agreement of the client.

(4) Notified bodies shall keep at the disposal of the Authority

the relevant documents concerning the assessment of the

qualifications of the subcontractor or the subsidiary and the work

carried out by them under Schedule II.

(1) An accredited in-house body may be used to carry Accredited in-

out conformity assessment activities for the undertaking of which it house bodies

forms a part for the purpose of implementing the procedures set out in

point 2 (Module A2) and point 5 (Module C2) of Schedule II. That

body shall constitute a separate and distinct part of the undertaking

and shall not participate in the design, production, supply,

installation, use or maintenance of the measuring instruments it

assesses.

(2) An accredited in-house body shall meet the following

requirements

(a)

it shall be accredited in accordance with Regulation

(EC) No 765/2008;

(b) the body and its personnel shall be organisationally

identifiable and have reporting methods within the undertaking

of which they form a part which ensure their impartiality and

demonstrate it to the relevant national accreditation body;

(c)

neither the body nor its personnel shall be

responsible for the design, manufacture, supply, installation,

operation or maintenance of the measuring instruments they

assess nor shall they engage in any activity that might conflict

with their independence of judgment or integrity in relation to

their assessment activities;

(d) it shall supply its services exclusively to the

undertaking of which it forms a part.

(3) An accredited in-house body shall not be notified the

Authority, but information concerning its accreditation shall be given

by the undertaking of which it forms a part or by the National

Accreditation Board (Malta) to the Authority at the request of the

Authority.

(1) A conformity assessment body established in Malta Application for

shall submit an application for notification under these regulations to notification.

the Authority.

(2) The application for notification shall be accompanied by a

description of the conformity assessment activities, the conformity

assessment module or modules and the measuring instrument or

measuring instruments for which that body claims to be competent, as

well as by an accreditation certificate, where one exists, issued by

National Accreditation Board (Malta) attesting that the conformity

assessment body fulfils the requirements laid down in regulation 27.

(1) The Authority may notify only conformity

assessment bodies which have satisfied the requirements laid down in

regulation 27.

(2) They shall notify the Commission and the other Member

States using the electronic notification tool developed and managed

by the Commission.

(3) The notification shall include information on the kind(s) of

measuring instrument(s) for which each body has been designated

and, where relevant, the instrument accuracy classes, the measuring

range, the measurement technology, and any other instrument

characteristic limiting the scope of the notification. The notification

shall include full details of the conformity assessment activities, the

conformity assessment module or modules and measuring instrument

or measuring instruments concerned and the relevant attestation of

competence.

(4) The body concerned may perform the activities of a

notified body only where no objections are raised by the Commission

or the other Member States within two weeks of a notification where

an accreditation certificate is used.

Only such a body shall be considered a notified body for the

purposes of these regulations.

(6) The Authority shall notify the Commission and the other

Member States of any subsequent relevant changes to the notification.

(1) Where the Authority has ascertained or has been

informed that a notified body no longer meets the requirements laid

down in regulation 27, or that it is failing to fulfil its obligations, the

Authority shall restrict, suspend or withdraw notification as

appropriate, depending on the seriousness of the failure to meet those

requirements or fulfil those obligations. It shall immediately inform

the Commission and the other Member States accordingly.

(2) In the event of restriction, suspension or withdrawal of

notification, or where the notified body has ceased its activity, the

Authority shall take appropriate steps to ensure that the files of that

body are either processed by another notified body or kept available

for the Authority.

(1) The Authority shall provide the Commission, on

request, with all information relating to the basis for the notification

or the maintenance of the competence of the notified body concerned.

(1) Notified bodies shall carry out

conformity Operational

assessment obligations

assessments in accordance with the conformity

notified bodies.

procedures provided for in Schedule II.

(2) Conformity assessments shall be carried out in a

proportionate manner, avoiding unnecessary burdens for economic

operators. Conformity assessment bodies shall perform their activities

taking due account of the size of an undertaking, the sector in which it

operates, its structure, the degree of complexity of the measuring

instrument technology in question and the mass or serial nature of the

production process.

In so doing they shall nevertheless respect the degree of rigour

and the level of protection required for the compliance of the

measuring instrument with these regulations.

(3) Where a notified body finds that the essential requirements

set out in Schedule I and in the relevant instrument-specific Schedule

or corresponding harmonised standards, normative documents or

other technical specifications have not been met by a manufacturer, it

shall require that manufacturer to take appropriate corrective

measures and shall not issue a certificate of conformity.

(4) Where, in the course of the monitoring of conformity

following the issue of a certificate, a notified body finds that a

measuring instrument no longer complies, it shall require the

manufacturer to take appropriate corrective measures and shall

suspend or withdraw the certificate if necessary.

(5) Where corrective measures are not taken or do not have the

required effect, the notified body shall restrict, suspend or withdraw

any certificates, as appropriate.

The Authority shall ensure that an appeal procedure Appeal against

decisions of

against decisions of the notified bodies is available.

notified bodies.

(1)

Notified bodies shall inform the Authority of the Information

obligation on

following

notified bodies.

(a)

any refusal, restriction, suspension or withdrawal of

a certificate;

(b) any circumstances affecting the scope of or

conditions for notification;

(c)

any request for information which they have

received from market surveillance authorities regarding

conformity assessment activities;

(d) on request, conformity assessment activities

performed within the scope of their notification and any other

activity performed, including cross-border activities and

subcontracting.

(2) Notified bodies shall provide the other bodies notified

under these regulations carrying out similar conformity assessment

activities covering the same measuring instruments with relevant

information on issues relating to negative and, on request, positive

conformity assessment results.

The Authority shall ensure that the bodies notified by them

participate in the work of that group or those groups, directly or by

means of designated representatives.

Regulation 16(3) and Regulation 16 to 29 of Regulation

(EC) No 765/2008 shall apply to measuring instruments.

(1) Where the Authority have sufficient reason to

believe that a measuring instrument covered by these regulations

presents a risk to aspects of public interest protection covered by

these regulations, they shall carry out an evaluation in relation to the

measuring instrument concerned covering all relevant requirements

laid down in these regulations. The relevant economic operators shall

cooperate as necessary with the Authority for that purpose.

Where, in the course of the evaluation referred to in the first

paragraph, the Authority finds that the measuring instrument does not

comply with the requirements laid down in these regulations, it shall

without delay require the relevant economic operator to take all

appropriate corrective actions to bring the measuring instrument into

compliance with those requirements, to withdraw the measuring

instrument from the market, or to recall it within a reasonable period,

commensurate with the nature of the risk, as they may prescribe.

The Authority shall inform the relevant notified body

accordingly.

Regulation 21 of Regulation (EC) No 765/2008 shall apply to

the measures referred to in the second paragraph.

(2) Where the Authority considers that non-compliance is not

restricted to Malta, it shall inform the Commission and the other

Member States of the results of the evaluation and of the actions

which they have required the economic operator to take.

(3) The economic operator shall ensure that all appropriate

corrective action is taken in respect of all the measuring instruments

concerned that it has made available on the market throughout the

Union.

(4) Where the relevant economic operator does not take

adequate corrective action within the period referred to in the second

paragraph of sub-regulation (1), the Authority shall take all

appropriate provisional measures to prohibit or restrict the measuring

instrument being made available on their national market, to

withdraw the measuring instrument from that market or to recall it.

The Authority shall inform the Commission and the other

Member States, without delay, of those measures.

(5) The information referred to in the second paragraph of

sub-regulation (4) shall include all available details, in particular the

data necessary for the identification of the non-compliant measuring

instrument, the origin of the measuring instrument, the nature of the

non-compliance alleged and the risk involved, the nature and duration

of the national measures taken and the arguments put forward by the

relevant economic operator. In particular, the Authority shall indicate

whether the non-compliance is due to either of the following

(a)

failure of the measuring instrument to meet

requirements relating to aspects of public interest protection laid

down in these regulations; or

(b) shortcomings in the harmonised standards or

normative documents referred to in regulation 18 conferring a

presumption of conformity.

(6) Member States other than Malta initiating the procedure

under this regulation shall without delay inform the Commission and

the other Member States of any measures adopted and of any

additional information at their disposal relating to the non-

compliance of the measuring instrument concerned, and, in the event

of disagreement with the adopted national measure, of their

objections.

(7) Where, within three months of receipt of the information

referred to in the second paragraph of sub-regulation (4), no objection

has been raised by either a Member State or the Commission in

respect of a provisional measure taken the Authority, that measure

shall be deemed justified.

(8) The Authority shall ensure that appropriate restrictive

measures, such as withdrawal of the measuring instrument from the

market, are taken in respect of the measuring instrument concerned,

without delay.

If the national measure is considered justified, the

Authority shall take the necessary measures to ensure that the non-

compliant measuring instrument is withdrawn from their market, and

shall inform the Commission accordingly. If the national measure is

considered unjustified, the Authority shall withdraw that measure.

(1) Where, having carried out an evaluation under

regulation 40(1), the Authority finds that although a measuring

instrument is in compliance with these regulations, it presents a risk

to aspects of public interest protection, it shall require the relevant

economic operator to take all appropriate measures to ensure that the

measuring instrument concerned, when placed on the market, no

longer presents that risk, to withdraw the measuring instrument from

the market or to recall it within a reasonable period, commensurate

with the nature of the risk, as it may prescribe.

(2) The economic operator shall ensure that corrective action

is taken in respect of all the measuring instruments concerned that he

has made available on the market throughout the Union.

(3) The Authority shall immediately inform the Commission

and the other Member States that information shall include all

available details, in particular the data necessary for the identification

of the measuring instrument concerned, the origin and the supply

chain of the measuring instrument, the nature of the risk involved and

the nature and duration of the national measures taken.

(1) Without prejudice to regulation 40, where the

Authority makes one of the following findings, it shall require the

relevant economic operator to put an end to the non-compliance

concerned

(a)

the CE marking or the supplementary metrology

marking has been affixed in violation of Regulation 30 of

Regulation (EC) No 765/2008 or of regulation 22 of these

regulations;

(b) the CE marking or the supplementary metrology

marking has not been affixed;

(c)

the identification number of the notified body, where

that body is involved in the production control phase, has been

affixed in violation of regulation 22 or has not been affixed;

(d) the EU declaration of conformity does not

accompany the measuring instrument;

(e)

the EU declaration of conformity has not been

drawn up correctly;

(f)

technical documentation is either not available or

not complete;

(g) the information referred to in regulation 10(6) or

regulation 12(3) is absent, false or incomplete;

(h) any other administrative requirement provided for in

regulation 9 or regulation 12 is not fulfilled.

(2) Where the non-compliance referred to in sub-regulation (1)

persists the Authority shall take all appropriate measures to restrict or

prohibit the measuring instrument being made available on the market

or ensure that it is recalled or withdrawn from the market.

(1) the Authority shall not impede the making available Transitory

on the market and/or the putting into use of measuring instruments provisions.

covered by Regulation 2004/22/EC which are in conformity with that

Regulation and which were placed on the market before 20 April

2016. Certificates issued under Regulation 2004/22/EC shall be valid

under these regulations.

(2) The effects of regulation 23 of Regulation 2004/22/EC

shall continue until 30th October, 2016.

(1) Where reference is made to this sub-regulation, Committee

procedure.

Regulation 4 of Regulation (EU) No. 182/2011 shall apply.

(2) Where reference is made to this sub-regulation, Regulation

5 of Regulation (EU) No. 182/2011 shall apply.

The Measuring Instruments Regulations are hereby Repeal.

repealed.