Non-Automatic Weighing Instruments, 2016

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

L.N. 123 of 2016

METROLOGY ACT

(CAP. 454)

Non-Automatic Weighing Instruments, 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 Non–Automatic Citation and

commencement.

Weighing Instruments, 2016.

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

2016.

ESSENTIAL REQUIREMENTS

The terminology used is that of the International Organisation of Legal

Metrology.

Preliminary observation

Where an instrument includes, or is connected to, more than one indicating or

printing device used for the applications listed in paragraphs (a) to (f) of

regulation 2(3), those devices which repeat the results of the weighing

operation and which cannot influence the correct functioning of the

instrument shall not be subject to the essential requirements if the weighing

results are printed or recorded correctly and indelibly by a part of the

instrument which meets the essential requirements and the results are

accessible to both parties concerned by the measurement. However, in the

case of instruments used for direct sales to the public, display and printing

devices for the vendor and the customer must fulfil the essential

requirements.

Metrological requirements

1. Units of mass

The units of mass used shall be the legal units within the meaning of Council

Directive 80/181/EEC of 20 December 1979 on the approximation of the

laws of the Member States relating to units of measurement. *

Subject to compliance with this condition, the following units are permitted

(a) SI units: kilogram, microgram, milligram, gram, tonne;

(b) imperial unit: troy ounce, if weighing precious metals;

(c) other non-SI unit: metric carat, if weighing precious stones.

For instruments that make use of the imperial unit of mass referred to above,

the relevant essential requirements specified below shall be converted to that

unit, using simple interpolation.

2. Accuracy classes

(1)

The following accuracy classes have been defined

(a) I special

* OJ L 39, 15.2.1980, p. 40.

(b) II high

(c) III medium

(d) IIII ordinary

The specifications of these classes are given in Table 1 The minimum

capacity is reduced to 5 e for instruments in classes II and III for determining

a conveying tariff.

(2)

Scale intervals

(2.1) The actual scale interval (d) and the verification scale interval (e) shall be in

the form: 1 × 10 k , 2 × 10 k , or 5 × 10 k mass units,

k being any integer or zero.

(2.2) For all instruments other than those with auxiliary indicating devices

d = e.

(2.3) For instruments with auxiliary indicating devices the following conditions

apply

e = 1 × 10 k g;

d < e ≤ 10 d.

Those conditions do not apply for instruments of class I with d < 10 –4 g, for

which e =10 –3 g.

3. Classification

Instruments with one weighing range

Instruments equipped with an auxiliary indicating device shall belong to class

I or class II. For these instruments the minimum capacity lower limits for

these two classes are obtained from Table 1 by replacement in column 3 of

the verification scale interval (e) by the actual scale interval (d).

If d < 10 –4 g, the maximum capacity of class I may be less than 50 000 e.

(2)

Instruments with multiple weighing ranges

Multiple weighing ranges are permitted, provided they are clearly indicated

on the instrument. Each individual weighing range is classified according to

point 3.1. If the weighing ranges fall into different accuracy classes the

instrument shall comply with the severest of the requirements that apply for

the accuracy classes in which the weighing ranges fall.

(3)

Multi – interval instruments

(3.1) Instruments with one weighing range may have several partial weighing

ranges (multi-interval instruments).

Multi-interval instruments shall not be equipped with an auxiliary indicating

device.

(3.2) Each partial weighing range i of multi-interval instruments is defined by

(3.3) The partial weighing ranges are classified according to Table 2. All partial

weighing ranges shall fall into the same accuracy class, that class being the

instrument’s accuracy class.

4. Accuracy

(1)

On implementation of the procedures laid down in regulation 14, the error of

indication shall not exceed the maximum permissible error of indication as

shown in Table 3. In the case of digital indication the error of indication shall

be corrected for the rounding error.

The maximum permissible errors apply to the net value and tare value for all

possible loads, excluding preset tare values.

(2)

The maximum permissible errors in service are twice the maximum

permissible errors fixed in Section 4.1.

5. Weighing results of an instrument shall be repeatable, and shall be

reproducible by the other indicating devices used and in accordance with

other methods of balancing used.

The weighing results shall be sufficiently insensitive to changes in the

position of the load on the load receptor.

6. The instrument shall react to small variations in the load.

7. Influence quantities and time

(1)

Instruments of classes II, III and IIII, liable to be used in a tilted position,

shall be sufficiently insensitive to the degree of tilting that can occur in

normal use.

(2)

The instruments shall meet the metrological requirements within the

temperature range specified by the manufacturer. The value of this range

shall be at least equal to

(a) 5°C for an instrument in class I;

(b) 15°C for an instrument in class II;

(c) 30°C for an instrument in class III or IIII.

In the absence of a manufacturer’s specification, the temperature range of –

10°C to + 40°C applies .

(3)

Instruments operated from a mains power supply shall meet the metrological

requirements under conditions of power supply within the limits of normal

fluctuation.

Instruments operated from battery power shall indicate whenever the voltage

drops below the minimum required value and shall under those circumstances

either continue to function correctly or be automatically put out of service.

(4)

Electronic instruments, except those in class I and in class II if e is less than 1

g, shall meet the metrological requirements under conditions of high relative

humidity at the upper limit of their temperature range.

(5)

Loading an instrument in class II, III or IIII for a prolonged period of time

shall have a negligible influence on the indication at load or on the zero

indication immediately after removal of the load.

(6)

Under other conditions the instruments shall either continue to function

correctly or be automatically put out of service.

Design and construction

8. General requirements

(1)

Design and construction of the instruments shall be such that the instruments

will preserve their metrological qualities when properly used and installed

and when used in an environment for which they are intended. The value of

the mass must be indicated.

(2)

When exposed to disturbances, electronic instruments shall not display the

effects of significant faults, or shall automatically detect and indicate them.

Upon automatic detection of a significant fault, electronic instruments shall

provide a visual or audible alarm that shall continue until the user takes

corrective action or the fault disappears.

(3)

The requirements of points 8.1 and 8.2 shall be met on a lasting basis during a

period of time that is normal in view of the intended use of such instruments.

Digital electronic devices shall always exercise adequate control of the

correct operation of the measuring process, of the indicating device, and of all

data storage and data transfer.

Upon automatic detection of a significant durability error, electronic

instruments shall provide a visual or audible alarm that shall continue until

the user takes corrective action or the error disappears.

(4)

When external equipment is connected to an electronic instrument through an

appropriate interface the metrological qualities of the instrument shall not be

adversely influenced.

(5)

The instruments shall have no characteristics likely to facilitate fraudulent

use, whereas possibilities for unintentional misuse shall be minimal.

Components that may not be dismantled or adjusted by the user shall be

secured against such actions.

(6)

Instruments shall be designed to permit ready execution of the statutory

controls laid down by this Regulation.

9. Indication of weighing results and other weight values

The indication of the weighing results and other weight values shall be

accurate, unambiguous and non-misleading and the indicating device shall

permit easy reading of the indication under normal conditions of use.

The names and symbols of the units referred to in point 1 of this Schedule

shall comply with the provisions of Directive 80/181/EEC with the addition

of the symbol for the metric carat which shall be the symbol ‘ct’.

Indication shall be impossible above the maximum capacity (Max), increased

by 9 e.

An auxiliary indicating device is permitted only to the right of the decimal

mark. An extended indicating device may be used only temporarily, and

printing shall be inhibited during its functioning.

Secondary indications may be shown, provided that they cannot be mistaken

for primary indications.

10. Printing of weighing results and other weight values

Printed results shall be correct, suitably identified and unambiguous. The

printing shall be clear, legible, non- erasable and durable.

11. Levelling

When appropriate, instruments shall be fitted with a levelling device and a

level indicator, sufficiently sensitive to allow proper installation.

12. Zeroing

Instruments may be equipped with zeroing devices. The operation of these

devices shall result in accurate zeroing and shall not cause incorrect

measuring results.

13. Tare devices and preset tare devices

The instruments may have one or more tare devices and a preset tare device.

The operation of the tare devices shall result in accurate zeroing and shall

ensure correct net weighing. The operation of the preset tare device shall

ensure correct determination of the calculated net value.

14. Instruments for direct sales to the public, with a maximum capacity not

greater than 100 kg: additional requirements

Instruments for direct sale to the public shall show all essential information

about the weighing operation and, in the case of price-indicating instruments,

shall clearly show the customer the price calculation of the product to be

purchased.

The price to pay, if indicated, shall be accurate.

enough for the customer to read them properly.

weighing and price computation only if all indications related to all

transactions are printed clearly and unambiguously and are conveniently

arranged on a ticket or label for the customer.

Instruments shall bear no characteristics that can cause, directly or indirectly,

indications the interpretation of which is not easy or straightforward.

Instruments shall safeguard customers against incorrect sales transactions due

to their malfunctioning.

Auxiliary indicating devices and extended indicating devices are not

permitted. Supplementary devices are permitted only if they cannot lead to

fraudulent use.

Instruments similar to those normally used for direct sales to the public which

do not satisfy the requirements of this Section must carry near to the display

the indelible marking ‘Not to be used for direct sale to the public’.

15. instruments for direct sale to the public, as far as applicable to the instrument

in question. The printing of a price label shall be impossible below a

minimum capacity.

(1)

These regulations

Scope.

(a)

implement Directive 2014/31/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);

(b) cover non-automatic weighing instruments which

are new to the Union market when they are placed on the

market; that is to say they are either new non-automatic

weighing instruments made by a manufacturer established in the

Union or non-automatic weighing instruments, whether new or

second-hand, imported from a third country; and

(c)

apply to all non-automatic weighing instruments.

(2) For the purposes of these regulations, the following

categories of use of non-automatic weighing instruments shall be

distinguished

(a)

the

determination

of

mass

for

commercial

transactions;

(b) the determination of mass for the calculation of a

toll, tariff, tax, bonus, penalty, remuneration, indemnity or

similar type of payment;

(c)

the determination of mass for the application of laws

or regulations or for an expert opinion given in court

proceedings;

(d) the determination of mass in the practice of

medicine for weighing patients for the purposes of monitoring,

diagnosis and medical treatment;

(e)

the determination of mass for making up medicines

on prescription in a pharmacy and determination of mass in

analyses carried out in medical and pharmaceutical laboratories;

(f)

the determination of price on the basis of mass for

the purposes of direct sales to the public and the making-up of

pre-packages;

(g) all applications other than those listed in paragraphs

(a) to (f).

CONFORMITY ASSESSMENT PROCEDURES

1. 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 any of the following manners

— Examination of a specimen, representative of the production envisaged,

of the complete instrument (production type);

—

assessment of the adequacy of the technical design of the instrument

through examination of the technical documentation and supporting

evidence referred to in point 1.3, 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);

—

Assessment of the adequacy of the technical design of the instrument

through examination of the technical documentation and supporting

evidence referred to in point 1.3, without examination of a specimen

(design type).

(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. 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 technical documentation shall contain, wherever applicable, at least

the following elements

(i)

a general description of the instrument;

(ii) conceptual design and manufacturing drawings and schemes of

components, sub-assemblies, circuits, etc.;

(iii) descriptions and explanations necessary for the understanding of

those drawings and schemes and the operation of the instrument;

(iv) a list of the harmonised standards applied in full or in part the

references of which have been published in the Official Journal of

the European Union, and, where those harmonised standards have

not been applied, descriptions of the solutions adopted to meet the

essential requirements of these regulations, including a list of other

relevant technical specifications applied. In the event of partly

applied harmonised standards, the technical documentation shall

specify the parts which have been applied;

(v) results of design calculations made, examinations carried out, etc.;

(vi) test reports;

(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

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

(4.1) examine the technical documentation and supporting evidence to assess the

adequacy of the technical design of the instrument;

For the specimen(s)

(4.2) 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, as well as the elements which have been designed in accordance

with other relevant technical specifications;

(4.3) 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, these have been applied correctly;

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

check whether, where the solutions in the relevant harmonised standards have

not been applied, the solutions adopted by the manufacturer applying other

relevant technical specifications meet the corresponding essential

requirements of these regulations;

(4.5) agree with the manufacturer on a location where the examinations and tests

will be carried out.

(5)

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

activities undertaken in accordance with point 1.4 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, that apply to the

instrument concerned, 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 Annexes attached.

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

relevant information to allow the conformity of manufactured instruments

with the examined type to be evaluated and to allow for in-service control.

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

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

years each. In the event of fundamental changes to the design of the

instrument, e.g. as a result of the application of new techniques, the validity

of EU-type examination certificate may be limited to two years and extended

by three years.

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 appraised 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. 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.

(8)

Each notified body shall inform its notifying 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 its

notifying authority the list of such certificates and/or any additions thereto

refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies concerning the EU-

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

refused, withdrawn, suspended or otherwise restricted, and, upon request,

concerning such certificates and/or additions thereto which it has issued.

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 annexes and additions, as

well as the technical file including the documentation submitted by the

manufacturer, until the expiry of the validity of that certificate.

(9)

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.

(10) The manufacturer’s authorised representative may lodge the application

referred to in point 1.3 and fulfil the obligations set out in points 1.7 and 1.9,

provided that they are specified in the mandate.

2. 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 2.2 and 2.5, and ensures and

declares on his sole responsibility that the 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 instruments concerned as specified

in point 2.3, and shall be subject to surveillance as specified in point 2.4.

(3)

Quality system

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

system with the notified body of his choice, for the 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; and

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

type examination certificate.

(3.2) The quality system shall ensure that the 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. 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 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, etc.;

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

and the effective operation of the quality system.

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

satisfies the requirements referred to in point 2.3.2.

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 2.3.1(e) 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.

(3.4) 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.

(3.5) 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 2.3.2 or whether a reassessment 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

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

the obligations arising out of the approved quality system.

(4.2) The manufacturer shall, for assessment purposes, allow the notified body

access to the manufacture, inspection, and 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, etc.

(4.3) 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.

(4.4) 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

(5.1) 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 2.3.1, 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.

(5.2) 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.

(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 2.3.1;

(b) the information relating to the change referred to in point 2.3.5, as

approved;

(c) the decisions and reports of the notified body referred to in points 2.3.5,

2.4.3 and 2.4.4.

(7)

Each notified body shall inform its notifying authority of quality system

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

available to its notifying authority the list of quality system approvals

refused, suspended or otherwise restricted.

(8)

Authorised representative

The manufacturer’s obligations set out in points 2.3.1, 2.3.5, 2.5 and 2.6 may

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

responsibility, provided that they are specified in the mandate.

3. 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 3.2, 3.4 and 3.7, and ensures and declares on his sole responsibility that

the instruments concerned satisfy the requirements of these regulations that

apply to them.

(2)

Technical documentation

The manufacturer shall establish the technical documentation. 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 technical

documentation shall, wherever applicable, contain at least the following

elements

(a) a general description of the instrument;

(b) conceptual design and manufacturing drawings and schemes of

components, sub-assemblies, circuits, etc.;

(c) descriptions and explanations necessary for the understanding of those

drawings and schemes and the operation of the instrument;

(d) a list of the harmonised standards applied in full or in part the references

of which have been published in the Official Journal of the European

Union, and, where those harmonised standards have not been applied,

descriptions of the solutions adopted to meet the essential requirements

of these regulations, including a list of other relevant technical

specifications applied. In the event of partly applied harmonised

standards, the technical documentation shall specify the parts which

have been applied;

(e) results of design calculations made, examinations carried out, etc.;

(f) test reports.

(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 production,

final product inspection and testing of the instruments concerned as specified

in point 3.5, and shall be subject to surveillance as specified in point 3.6.

(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 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 3.2.

(5.2) The quality system shall ensure compliance of the 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 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, etc.;

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

and the effective operation of the quality system.

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

satisfies the requirements referred to in point 3.5.2.

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 3.2 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.

(5.4) 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.

(5.5) 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 3.5.2 or whether reassessment 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

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

the obligations arising out of the approved quality system .

(6.2) 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 3.2;

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

data, qualification reports on the personnel concerned, etc.

(6.3) 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.

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

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

(7.1) 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 3.5.1, the latter’s identification

number to each individual instrument that satisfies the applicable

requirements of these regulations.

(7.2) 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.

(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 3.5.1;

(b) the information relating to the change referred to in point 3.5.5, as

approved;

(c) the decisions and reports of the notified body referred to in points 3.5.5,

3.6.3 and 3.6.4.

(9)

Each notified body shall inform its notifying authority of quality system

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

available to its notifying authority the list of quality system approvals

refused, suspended or otherwise restricted.

(10) Authorised representative

The manufacturer’s obligations set out in points 3.3, 3.5.1, 3.5.5, 3.7 and 3.8

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

responsibility, provided that they are specified in the mandate.

4. 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 4.2 and 4.5 and ensures and declares on his sole responsibility

that the instruments concerned, which have been subject to the provisions of

point 4.3, 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

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 appropriate

examinations and tests in order to check the conformity of the instruments

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

with the appropriate requirements of the Directive 2014/31.

The examinations and tests to check the conformity of the instruments with

the appropriate requirements shall be carried out by examination and testing

of every instrument as specified in point 4.4.

(4)

Verification of conformity by examination and testing of every instrument

(4.1) All instruments shall be individually examined and appropriate tests set out

in the relevant harmonised standard(s), and/or equivalent tests set out in other

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

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

certificate and with the appropriate requirements of these regulations.

In the absence of such a harmonised standard, the notified body concerned

shall decide on the appropriate tests to be carried out.

(4.2) 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)

Conformity marking and EU declaration of conformity

(5.1) 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 4.3, 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.

(5.2) 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.

If the notified body referred to in point 4.3 agrees and under its responsibility,

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

the instruments.

(6)

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

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

manufacturing process.

(7)

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 4.2.

5. 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 5.2, 5.3 and 5.6 and ensures and declares on his sole responsibility that

the instruments concerned, which have been subject to the provisions of point

5.4, are in conformity with the requirements of these regulations that apply to

them.

(2)

Technical documentation

(2.1) The manufacturer shall establish the technical documentation. 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 technical

documentation shall, wherever applicable, contain at least the following

elements

(a) a general description of the instrument;

(b) conceptual design and manufacturing drawings and schemes of

components, sub-assemblies, circuits, etc.;

(c) descriptions and explanations necessary for the understanding of those

drawings and schemes and the operation of the instrument;

(d) a list of the harmonised standards applied in full or in part the references

of which have been published in the Official Journal of the European

Union, and, where those harmonised standards have not been applied,

descriptions of the solutions adopted to meet the essential requirements

of these regulations, including a list of other relevant technical

specifications applied. In the event of partly applied harmonised

standards, the technical documentation shall specify the parts which

have been applied;

(e) results of design calculations made, examinations carried out, etc.;

(f) test reports.

(2.2) 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

instruments with the applicable requirements of these regulations.

(4)

Verification

A notified body chosen by the manufacturer shall carry out appropriate

examinations and tests to check the conformity of the instruments with the

applicable requirements of these regulations.

The examinations and tests to check the conformity with those requirements

shall be carried out by examination and testing of every instrument as

specified in point 5.5.

(5)

Verification of conformity by examination and testing of every instrument

(5.1) All instruments shall be individually examined and appropriate tests, set out

in the relevant harmonised standards and/or equivalent tests set out in other

relevant technical specifications, shall be carried out to verify conformity

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

standard the notified body concerned shall decide on the appropriate tests to

be carried out.

(5.2) 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)

Conformity marking and EU declaration of conformity

(6.1) 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 5.4, the latter’s identification number

to each individual instrument that satisfies the applicable requirements of

these regulations.

(6.2) 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.

If the notified body referred to in point 5.5 agrees and under its responsibility,

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

the instruments.

(7)

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

affix the notified body’s identification number to the 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 5.2.1 and 5.3.

6. 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 6.2, 6.3 and 6.5, and ensures and declares on his sole responsibility that

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

6.4, is in conformity with the requirements of these regulations that apply to

it.

(2)

Technical documentation

(2.1) The manufacturer shall establish the technical documentation and make it

available to the notified body referred to in point 6.4. 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 technical documentation

shall, wherever applicable, contain at least the following elements

(a) a general description of the instrument;

(b) conceptual design and manufacturing drawings and schemes of

components, sub-assemblies, circuits, etc.;

(c) descriptions and explanations necessary for the understanding of those

drawings and schemes and the operation of the instrument;

(d) a list of the harmonised standards applied in full or in part the references

of which have been published in the Official Journal of the European

Union, and, where those harmonised standards have not been applied,

descriptions of the solutions adopted to meet the essential requirements

of these regulations, including a list of other relevant technical

specifications applied. In the event of partly applied harmonised

standards, the technical documentation shall specify the parts which

have been applied;

(e) results of design calculations made, examinations carried out, etc.;

(f) test reports.

(2.2) 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 appropriate

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

equivalent tests set out in other relevant technical specifications, to check 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 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 shall 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

(5.1) 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 6.4, 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.

(6)

Authorised representative

The manufacturer’s obligations set out in points 6.2.2 and 6.5 may be

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

responsibility, provided that they are specified in the mandate.

7. Common provisions

(1)

The conformity assessment according to Module D, D1, F, F1 or G may be

carried out at the manufacturer’s works or any other location if transport to

the place of use does not require dismantling of the instrument, if the putting

into service at the place of use does not require assembly of the instrument or

other technical installation work likely to affect the instrument’s

performance, and if the gravity value at the place of putting into service is

taken into consideration or if the instrument’s performance is insensitive to

gravity variations. In all other cases, it shall be carried out at the place of use

of the instrument.

(2)

If the instrument’s performance is sensitive to gravity variations the

procedures referred to in point 7.1 may be carried out in two stages, with the

second stage comprising all examinations and tests of which the outcome is

gravity-dependent, and the first stage all other examinations and tests. The

second stage shall be carried out at the place of use of the instrument. If a

Member State has established gravity zones on its territory the expression ‘at

the place of use of the instrument’ may be read as ‘in the gravity zone of use

of the instrument’.

(2.1) Where a manufacturer has opted for execution in two stages of one of the

procedures mentioned in point 7.1, and where these two stages will be carried

out by different parties, an instrument which has undergone the first stage of

the procedure shall bear the identification number of the notified body

involved in that stage.

(2.2) The party which has carried out the first stage of the procedure shall issue for

each of the instruments a certificate containing the data necessary for

identification of the instrument and specifying the examinations and tests that

have been carried out.

The party which carries out the second stage of the procedure shall carry out

those examinations and tests that have not yet been carried out.

The manufacturer or his authorised representative shall ensure that he is able

to supply the notified body’s certificates of conformity on request.

(2.3) A manufacturer who has opted for Module D or D1 in the first stage may

either use this same procedure in the second stage or decide to continue in the

second stage with Module F or F1 as appropriate.

(2.4) The CE marking and the supplementary metrology marking shall be affixed

to the instrument on completion of the second stage, along with the

identification number of the notified body which took part in the second

stage.

In these regulations, unless the context otherwise requires

"accreditation" means accreditation as defined in paragraph 10

of 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 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 an

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 an

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

paragraph (c) of paragraph 1 of Article 2 of Regulation (EU) No

1025/2012;

"importer" means any natural or legal person established within

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

Union market;

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

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 an instrument or has an instrument designed or

manufactured, and markets that instrument under his name or trade

mark;

"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;

"non-automatic weighing instrument" or "instrument" means a

weighing instrument requiring the intervention of an operator during

weighing;

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

instrument on the Union market;

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

instrument that has already been made available to the end-user;

"technical specification" means a document that prescribes

technical requirements to be fulfilled by an instrument;

"Union harmonisation legislation" means any Union legislation

harmonising the conditions for the marketing of products;

"Weighing instrument" means a measuring instrument serving

to determine the mass of a body by using the action of gravity on that

body. A weighing instrument may also serve to determine other mass-

related magnitudes, quantities, parameters or characteristics;

"withdrawal" means any measure aimed at preventing an

instrument in the supply chain from being made available on the

market.

INSCRIPTIONS

1. Instruments intended to be used for the applications listed in paragraphs (a) to

(f) of regulation 2(3)

(1)

Those instruments shall bear visibly, legibly and indelibly the following

inscriptions

(i)

the number of the EU-type examination certificate, where

appropriate;

(ii) the manufacturer’s name, registered trade name or registered trade

mark;

(iii) the accuracy class, enclosed in an oval or in two horizontal lines

joined by two half circles;

(iv) maximum capacity, in the form Max …;

(v) minimum capacity, in the form Min …;

(vi) verification scale interval, in the form e = …;

(vii) type, batch or serial number; and when applicable

(viii) for instruments consisting of separate but associated units

identification mark on each unit;

(ix) scale interval if it is different from e, in the form d = …;

(x) maximum additive tare effect, in the form T = + …;

(xi) maximum subtractive tare effect if it is different from Max, in the

form T = – …;

(xii) tare interval if it is different from d, in the form d T = …;

(xiii) maximum safe load if it is different from Max, in the form Lim …;

(xiv) the special temperature limits, in the form … o C/… o C;

(xv) ratio between load receptor and load.

(2)

Those instruments shall have adequate facilities for the affixing of the

conformity marking and inscriptions. These shall be such that it shall be

impossible to remove the conformity marking and inscriptions without

damaging them, and that the conformity marking and inscriptions shall be

visible when the instrument is in its regular operating position.

(3)

Where a data plate is used it shall be possible to seal the plate unless it cannot

be removed without being destroyed. If the data plate is sealable it shall be

possible to apply a control mark to it.

(4)

The inscriptions Max, Min, e, and d, shall also be shown near the display of

the result if they are not already located there.

(5)

Each load measuring device which is connected or can be connected to one or

more load receptors shall bear the relevant inscriptions relating to the said

load receptors.

2. Instruments not intended to be used for the applications listed in paragraphs

(a) to (f) of regulation 2(3) shall bear visibly, legibly and indelibly

— the manufacturer’s name, registered trade name or registered trade mark;

—

maximum capacity, in the form Max ….

Those instruments shall not bear the conformity marking as set out in these

Regulations.

3. Restrictive use symbol referred to in regulation 19

The restrictive use symbol shall be constituted by a capital letter ‘M’ printed

in black on a red background at least 25 mm × 25 mm square with two

intersecting diagonals forming a cross.

(1) The Authority shall take all steps to ensure that only

instruments that meet the applicable requirements of this regulation

may be made available on the market.

(2) The Authority shall take all steps to ensure that

instruments may not be put into service for the uses referred to in

paragraphs (a) to (f) of regulation 2(3) unless they meet the

requirements of these regulations.

(3) The Authority shall take all steps to ensure that

instruments put into service for the uses referred to in paragraphs (a)

to (f) of regulation 2(3) continue to conform to the applicable

requirements of these regulations.

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 used or references to the

other technical specifications in relation to which conformity is declared

7. The notified body … (name, number) performed … (description of

intervention) and issued the certificate

8. Additional information

Signed for and on behalf of

(place and date of issue)

(name, function)

(signature)

* It is optional for the manufacturer to assign a number to the declaration of conformity.

€2.16

Instruments used or intended to be used for the

applications listed in paragraphs (a) to (f) of regulation 2(3) shall

satisfy the essential requirements set out in Schedule I.

Where the instrument includes, or is connected to, devices

which are not used or intended to be used for the applications listed in

paragraphs (a) to (f) of regulation 2(3), such devices shall not be

subject to those essential requirements.

(1) The Authority shall not impede the making available

on the market of instruments which meet the requirements of these

regulations.

(2) The Authority shall not impede the putting into service, for

the uses referred to in paragraphs (a) to (f) of regulation 2(3), of

instruments which meet the requirements of these regulations.

(1) When placing on the market their instruments

intended to be used for the applications listed in paragraphs (a) to (f)

of regulation 2(3), manufacturers shall ensure that they have been

designed and manufactured in accordance with the essential

requirements set out in Schedule I.

(2) For the instruments intended to be used for the applications

listed in paragraphs (a) to (f) of regulation 2(3), manufacturers shall

draw up the technical documentation referred to in Schedule II and

carry out the relevant conformity assessment procedure referred to in

regulation 14 or have it carried out .

Where compliance of an instrument intended to be used for the

applications listed in paragraphs (a) to (f) of regulation 2(3) with the

applicable requirements has been 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.

(3) For the instruments intended to be used for the applications

listed in paragraphs (a) to (f) of regulation 2(3), manufacturers shall

keep the technical documentation and the EU declaration of

conformity for 10 years after the instrument has been placed on the

market.

(4) Manufacturers shall ensure that procedures are in place for

series production to remain in conformity with these regulations.

Changes in instrument design or characteristics and changes in the

harmonised standards or in other technical specifications by reference

to which conformity of an instrument is declared shall be adequately

taken into account.

When deemed appropriate with regard to the risks

presented by an instrument intended to be used for the applications

listed in paragraphs (a) to (f) of regulation 2(3), manufacturers shall

carry out sample testing of instruments made available on the market,

investigate, and, if necessary, keep a register of complaints, of non-

conforming instruments and instrument recalls, and shall keep

distributors informed of any such monitoring.

(5) Manufacturers shall ensure that instruments which they

have placed on the market bear a type, batch or serial number or other

element allowing their identification, as set out in Schedule III.

For the instruments intended to be used for the applications

listed in paragraphs (a) to (f) of regulation 2(3), manufacturers shall

affix the inscriptions provided for in point 1 of Schedule III.

For the instruments not intended to be used for the applications

listed in paragraphs (a) to (f) of regulation 2(3), manufacturers shall

affix the inscriptions provided for in point 2 of Schedule III.

Where an instrument which is intended to be used for any of the

applications listed in paragraphs (a) to (f) of regulation 2(3) includes,

or is connected to, devices which are not used or intended to be used

for the applications listed in paragraphs (a) to (f) of regulation 2(3),

manufacturers shall affix to each of those devices the restrictive use

symbol as provided for in regulation 19 and in point 3 of Schedule III.

(6) Manufacturers shall indicate on the instrument their name,

registered trade name or registered trade mark and the postal address

at which they can be contacted. The address shall indicate a single

paragraph at which the manufacturer can be contacted. The contact

details shall be in a language easily understood by end-users and the

Authority.

(7) Manufacturers shall ensure that the instrument intended to

be used for the applications listed in paragraphs (a) to (f) of regulation

2(3) is accompanied by instructions and information in a language

which can be easily understood by end-users, as determined by the

Authority. 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

an 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 instrument into

conformity, to withdraw it or recall it, if appropriate. Furthermore,

where the instrument presents a risk, manufacturers shall immediately

inform the competent national authorities of the Member States in

which they made the 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 instrument with these regulations, in at least English and, or

Maltese. The Authority at its request, on any action taken to eliminate

the risks posed by instruments which they have placed on the market.

(1) A manufacturer may, by a written mandate, appoint

an authorised representative.

The obligations laid down in regulation 7(1) and the obligation

to draw up technical documentation referred to in regulation 7(2)

shall not form part of the authorised representative’s mandate.

(2) 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 10

years after the 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 an instrument;

(c)

cooperate with the competent national authorities, at

their request, on any action taken to eliminate the risks posed by

instruments covered by the authorised representative’s mandate.

(1)

Importers shall place only compliant instruments on Obligations of

importers.

the market.

(2) Before placing on the market an instrument intended to be

used for the applications listed in paragraphs (a) to (f) of regulation

2(3), importers shall ensure that the appropriate conformity

assessment procedure referred to in regulation 14 has been carried out

by the manufacturer. They shall ensure that the manufacturer has

drawn up the technical documentation, that the instrument bears the

CE marking and the supplementary metrology marking and is

accompanied by the required documents, and that the manufacturer

has complied with the requirements set out in regulation 7(5) and (6).

Where an importer considers or has reason to believe that an

instrument intended to be used for the applications listed in

paragraphs (a) to (f) of regulation 2(3) is not in conformity with the

essential requirements set out in Schedule I, he shall not place the

instrument on the market until it has been brought into conformity.

Furthermore, where the instrument presents a risk, the importer shall

inform the manufacturer and the Authority to that effect.

Before placing on the market an instrument not intended to be

used for the applications listed in paragraphs (a) to (f) of regulation

2(3) importers shall ensure that the manufacturer has complied with

the requirements set out in regulation 7(5) and (6).

(3) Importers shall indicate on the instrument their name,

registered trade name or registered trade mark and the postal address

at which they can be contacted. Where this would require the

packaging to be opened, those indications may be given on the

packaging and in a document accompanying the instrument. The

contact details shall be in at least English and, or Maltese.

(4) Importers shall ensure that the instrument intended to be

used for the applications listed in paragraphs (a) to (f) of regulation

2(3) is accompanied by instructions and information in a language

which can be easily understood by end-users, as determined by the

Authority.

(5) Importers shall ensure that, while an instrument intended

to be used for the applications listed in paragraphs (a) to (f) of

regulation 2(3) is under their responsibility, its storage or transport

conditions do not jeopardise its compliance with the essential

requirements set out in Schedule I.

(6) When deemed appropriate with regard to the risks

presented by an instrument intended to be used for the applications

listed in paragraphs (a) to (f) of regulation 2(3), importers shall carry

out sample testing of instruments made available on the market,

investigate, and, if necessary, keep a register of complaints, of non-

conforming instruments and instrument recalls, and shall keep

distributors informed of any such monitoring.

(7) Importers who consider or have reason to believe that an

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 instrument into conformity, to withdraw it or

recall it, if appropriate. Furthermore, where the instrument presents a

risk, importers shall immediately inform the Authority, giving details,

in particular, of the non-compliance and of any corrective measures

taken.

(8) For the instruments intended to be used for the applications

listed in paragraphs (a) to (f) of regulation 2(3), importers shall, for

10 years after the instrument has been placed on the market keep a

copy of the EU declaration of conformity at the disposal of the market

surveillance authorities and ensure that the technical documentation

can be made available to those authorities, upon request.

(9) 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

an instrument 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 instruments which they have placed on

the market.

(1) When making an instrument available on the market

distributors shall act with due care in relation to the requirements of

these regulations.

(2) Before making an instrument intended to be used for the

applications listed in paragraphs (a) to (f) of regulation 2(3) available

on the market, distributors shall verify that the instrument bears the

CE marking, and the supplementary metrology marking, that it is

accompanied by the required documents and by instructions and

information in at least English and, or Maltese, and that the

manufacturer and the importer have complied with the requirements

set out in regulation 7(5) and (6) and regulation 9(3) respectively.

Where a distributor considers or has reason to believe that an

instrument intended to be used for the applications listed in

paragraphs (a) to (f) of regulation 2(3) is not in conformity with the

essential requirements set out in Schedule I, he shall not make the

instrument available on the market until it has been brought into

conformity. Furthermore, where the instrument presents a risk, the

distributor shall inform the manufacturer or the importer to that effect

as well as the Authority.

Before making an instrument not intended to be used for the

applications listed in paragraphs (a) to (f) of regulation 2(3) available

on the market, distributors shall verify that the manufacturer and the

importer have complied with the requirements set out in regulation

7(5) and (6) and regulation 9(3) respectively.

(3) Distributors shall ensure that, while an instrument intended

to be used for the applications listed in paragraphs (a) to (f) of

regulation 2(3) is under their responsibility, its storage or transport

conditions do not jeopardise its compliance with the essential

requirements set out in Schedule I.

(4) Distributors who consider or have reason to believe that an

instrument which they have made available on the market is not in

conformity with these regulations shall make sure that the corrective

measures necessary to bring that instrument into conformity, to

withdraw it or recall it, if appropriate, are taken. Furthermore, where

the instrument presents a risk, distributors shall immediately inform

the Authority to that effect, giving details, in particular, of the non-

compliance and of any corrective measures taken.

An importer or distributor shall be considered a Cases in which

manufacturer for the purposes of these regulations and he shall be obligations

manufacturers

subject to the obligations of the manufacturer under regulation 7, apply

importers and

where he places an instrument on the market under his name or trade distributors.

mark or modifies an instrument already placed on the market in such

a way that compliance with these regulations may be affected.

(1) For instruments intended to be used for the Identification of

applications listed in paragraphs (a) to (f) of regulation 2(3), economic

operators.

economic operators shall, on request, identify the following to the

Authority

(a)

any economic operator who has supplied them with

an instrument;

(b) any economic operator to whom they have supplied

an instrument.

(2) Economic operators shall be able to present the

information referred to in sub-regulation (1) for 10 years after they

have been supplied with the instrument and for 10 years after they

have supplied the instrument.

Instruments which are in conformity with harmonised

standards or parts thereof the references of which have been

published in the Official Journal of the European Union shall be

presumed to be in conformity with the essential requirements set out

in Schedule I covered by those standards or parts thereof.

(1) The conformity of instruments to the essential

requirements set out in Schedule I may be established by either of the

following conformity assessment procedures as selected by the

manufacturer

(a)

Module B as set out in point 1 of Schedule II,

followed either by Module D as set out in point 2 of Schedule II,

or by Module F as set out in point 4 of Schedule II

Provided that Module B shall not be compulsory for

instruments which do not use electronic devices and the load-

measuring device of which does not use a spring to balance the

load. For those instruments not submitted to Module B, Module

D1 as set out in point 3 of Schedule II or Module F1 as set out in

point 5 of Schedule II shall apply;

(b)

Module G as set out in point 6 of Schedule II.

(2) Any documents and correspondence relating to the

conformity assessment procedures referred to in sub-regulation (1)

shall be drawn up in at least English and, or Maltese.

(1) The EU declaration of conformity shall state that the

fulfilment of the essential requirements set out in Schedule I has been

demonstrated.

(2) The EU declaration of conformity shall have the model

structure set out in Schedule IV, shall contain the elements specified

in the relevant modules set out in Schedule II and shall be

continuously updated. It shall be in at least English and, or Maltese.

(3) Where an 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

instrument with the requirements laid down in these regulations.

The conformity of an instrument intended to be used for Conformity

the applications listed in paragraphs (a) to (f) of regulation 2(3) with marking.

these regulations shall be indicated by the presence, on the

instrument, of the CE marking and the supplementary metrology

marking as specified in regulation 17

(1) The CE marking shall be subject to the general General

principles of the

principles set out in Article 30 of Regulation (EC) No 765/2008

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 Article 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

instrument or to its data plate.

marking, the

supplementary

metrology

(2) The CE marking and the supplementary metrology marking

other markings.

marking shall be affixed before the instrument is placed on the

market.

(3) The supplementary metrology marking shall immediately

follow the CE marking.

(4) The CE marking and the supplementary metrology

marking shall be followed by the identification number(s) of the

notified body or bodies involved in the production control phase as

set out in Schedule II.

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.

(5) The CE marking, the supplementary metrology marking

and the identification number(s) of the notified body or bodies may

be followed by any other mark indicating a special risk or use.

(6) 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 symbol referred to in regulation 7(5) and specified in

point 3 of Schedule III shall be affixed to the devices in a clearly

visible and indelible form.

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 regulation 26.

(2) The assessment and monitoring referred to in sub-

regulation (1) shall be carried out by the National Accreditation

Board (Malta).

(1) The Authority shall ensure that no conflict of

interest with conformity assessment bodies occurs.

(2) The Authority shall be organised and operated so as to

safeguard the objectivity and impartiality of its activities.

(3) The Authority shall 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.

(4) The Authority shall not offer or provide any activities that

conformity assessment bodies perform or consultancy services on a

commercial or competitive basis.

(5) The Authority shall safeguard the confidentiality of the

information it obtains.

(6) The Authority shall 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

procedures for the assessment and notification of conformity

assessment bodies and the monitoring of notified bodies, and of any

changes thereto.

(1) For the purposes of notification, a conformity

assessment body shall meet the requirements laid down in sub-

regulations (2) to (11).

(2) A conformity assessment body shall be established under

the 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 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

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 instruments

which they assess, nor the representative of any of those parties. This

shall not preclude the use of assessed instruments that are necessary

for the operations of the conformity assessment body or the use of

such 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

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.

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 instruments in relation to which it has been

notified, a conformity assessment body shall have at its disposal the

necessary

(a)

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

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, of the applicable

harmonised standards 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 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 Presumption of

conformity with the criteria laid down in the relevant harmonised conformity

notified bodies.

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 24 in

so far as the applicable harmonised standards cover those

requirements .

(1) Where a notified body subcontracts specific tasks Subsidiaries of

connected with conformity assessment or has recourse to a subsidiary, and

subcontracting

it shall ensure that the subcontractor or the subsidiary meets the by

bodies.

requirements set out in regulation 24 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) A conformity assessment body established in Malta

shall submit an application for notification under these regulations to

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 instrument or instruments for

which that body claims to be competent, as well as by an

accreditation certificate issued by the National Accreditation Board

(Malta) attesting that the conformity assessment body fulfils the

requirements laid down in regulation 24.

(1) The Authority may notify only conformity

assessment bodies which have satisfied the requirements laid down in

regulation 24

(2) The Authority 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 full details of the conformity

assessment activities, the conformity assessment module or modules

and instrument or 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.

(5) 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 24, 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) 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 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

instrument with these regulations.

(3) Where a notified body finds that the essential requirements

set out in Schedule I or corresponding harmonised standards 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 an

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 instruments with relevant information on

issues relating to negative and, on request, positive conformity

assessment results.

Notified bodies shall participate, directly or by means of

designated representatives, in the appropriate coordination and

cooperation groups for notified bodies organised by the Commission.

Regulation 15(3) and Articles 16 to 29 of Regulation (EC)

No 765/2008 shall apply to instruments covered by regulation 2 of

these regulations.

(1) Where the Authority has sufficient reason to believe

that an instrument covered by these regulations presents a risk to

aspects of public interest protection covered by these regulations, it

shall carry out an evaluation in relation to the 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 above, the

Authority finds that the 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 instrument into compliance with those

requirements, to withdraw the 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.

Article 21 of Regulation (EC) No 765/2008 shall apply to the

measures referred to in this regulation.

(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 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 sub-

regulation (1), the Authority shall take all appropriate provisional

measures to prohibit or restrict the instrument’s being made available

on their national market, to withdraw the 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) All information shall include all available details, in

particular the data necessary for the identification of the non-

compliant instrument, the origin of the 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 instrument to meet requirements

relating to the aspects of public interest protection laid down in

these regulations; or

(b) shortcomings in the harmonised standards referred

to in regulation 13 conferring a presumption of conformity.

(6) Member States other than the Member State 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 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,

no objection has been raised by either a Member State or the

Commission in respect of a provisional measure taken by the

Authority, that measure shall be deemed justified.

(8) The Authority shall ensure that appropriate restrictive

measures, such as withdrawal of the instrument from the market, are

taken in respect of the instrument concerned without delay.

If the national measure is considered justified, the

Authority shall take the necessary measures to ensure that the non-

compliant instrument is withdrawn from the 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 35, the Authority finds that although an 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 instrument

concerned, when placed on the market, no longer presents that risk, to

withdraw the 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 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 instrument concerned, the origin and the supply chain of the

instrument, the nature of the risk involved and the nature and duration

of the national measures taken.

(1) Without prejudice to regulation 35, 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 Article 30 of

Regulation (EC) No 765/2008 or of regulation 18 of these

regulations;

(b) the CE marking or the supplementary metrology

marking has not been affixed;

(c)

the inscriptions provided for in regulation 7(5) have

not been affixed or have been affixed in violation of regulation

7(5);

(d) the identification number of the notified body, where

that body is involved in the production control phase, has been

affixed in violation of regulation 17 or has not been affixed;

(e)

the EU declaration of conformity has not been

drawn up;

(f)

the EU declaration of conformity has not been

drawn up correctly;

(g) technical documentation is either not available or

not complete;

(h) the information referred to in regulation 7(6) or 9(3)

is absent, false or incomplete;

(i)

any other administrative requirement provided for in

regulation 7 or 9 is not fulfilled.

(2) Where the non-compliance referred to in regulation 38(1)

persists, the Authority shall take all appropriate measures to restrict

or prohibit the instrument being made available on the market or

ensure that it is recalled or withdrawn from the market .

Penalties applicable to infringements by economic Penalties.

operators of the provisions of national law adopted pursuant to these

regulations are stipulated in Part VI of Metrology Act.

(1) The Authority shall not impede the making available Transitory

on the market and/or the putting into service of instruments covered provisions.

by Regulation 2009/23/EC which are in conformity with that

Regulation and which were placed on the market before 20th April,

2016. (2) Certificates issued under Regulation 2009/23/EC shall be

valid under these regulations.