MEASURING INSTRUMENTS REGULATIONS (sl_454.15) | MT

Laws of Malta — Subsidiary Legislation 454.15 — MEASURING INSTRUMENTS REGULATIONS

Preamble — MEASURING INSTRUMENTS REGULATIONS Open official source

MEASURING INSTRUMENTS

SUBSIDIARY LEGISLATION 454.15

MEASURING INSTRUMENTS REGULATIONS

20th April, 2016 *

LEGAL NOTICE 122 of 2016.

Laws of Malta — Subsidiary Legislation 454.15 — MEASURING INSTRUMENTS REGULATIONS

Reg. 1 Citation and scope. — MEASURING INSTRUMENTS REGULATIONS Open official source

(1) The title of these regulations is the Measuring

Instruments Regulations.

(2) 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).

(3) 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).

(4) 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.

Laws of Malta — Subsidiary Legislation 454.15 — MEASURING INSTRUMENTS REGULATIONS

Schedule I — MEASURING INSTRUMENTS REGULATIONS Open official source

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 thereof.

Definitions

Measurand

The measurand is the particular quantity subject to

measurement.

Influence quantity

An influence quantity is a quantity that is not the

measurand but that affects the result of measurement.

Rated Operating Conditions The rated operating conditions are the values for the

measurand and influence quantities making up the

normal working conditions of an instrument.

Disturbance

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.

Critical change value

The critical change value is the value at which the

change in t he m easurem ent result is considered

undesirable.

Material Measure

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 environments

Climatic environments are the conditions in which

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.

Table 1

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 i t s m e t r o l og i c a l c h a r a c t e r i s t i c s o v e r a p e r i o d o f t im e es t i ma t e d b y th e

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.

Laws of Malta — Subsidiary Legislation 454.15 — MEASURING INSTRUMENTS REGULATIONS

Reg. 2 Definitions. — MEASURING INSTRUMENTS REGULATIONS Open official source

In these regulations, unless the context otherwise requires

"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,

*

see regulation 1(2) of these Regulations, as originally promulgated.

MEASURING INSTRUMENTS

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 m arket " m eans 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)

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 t he purposes for which it was

intended;

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

*

https://www.oiml.org/en

MEASURING INSTRUMENTS

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

m a k e s up a m e a s u r in g i n s t ru m e n t t o ge th e r wi t h o th e r su b-

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.

Laws of Malta — Subsidiary Legislation 454.15 — MEASURING INSTRUMENTS REGULATIONS

Schedule Ii — MEASURING INSTRUMENTS REGULATIONS Open official source

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

requi rements and cover, as far as r el ev an t for the assessment, the desig n,

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

s o l e r e s p o n s i b i l i t y t h a t t h e m e a s u r i n g i n s t r u m e n t s c o n c e r n e d s at i s f y t h e

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

MEASURING INSTRUMENTS

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

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 docum en ts have not b een applied, the solu tions ado pted 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.