Legalize / United Kingdom / Statutory-Instrument

The Measuring Instruments Regulations 2016

Type Statutory-Instrument

Publication 2016-11-29

Last updated 2025-02-27

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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Reform history JSON API

(f) conditions for compatibility with interfaces or regulated measuring instruments.

9

Groups of identical regulated measuring instruments used in the same location or used for utility measurements do not necessarily require individual instruction manuals.

9

Unless specified otherwise in an instrument-specific Schedule, the scale interval for a measured value shall be in the form 1 × 10ⁿ, 2 × 10ⁿ, or 5 × 10ⁿ, where n is any integer or zero. The unit of measurement or its symbol shall be shown close to the numerical value.

9

A material measure shall be marked with a nominal value or a scale, accompanied by the unit of measurement used.

9

The units of measurement used and their symbols shall be in accordance with the relevant enactments on units of measurement and their symbols.

9

All marks and inscriptions required under any requirement shall be clear, non-erasable, unambiguous and non-transferable.

Indication of result

10

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

10

The indication of any result shall be clear and unambiguous and accompanied by such marks and inscriptions necessary to inform the user of the significance of the result. Easy reading of the presented result shall be permitted under normal conditions of use. Additional indications may be shown provided they cannot be confused with the metrologically controlled indications.

10

In the case of hard copy the print or record shall also be easily legible and non-erasable.

10

A regulated measuring instrument for direct sales trading transactions shall be designed to present the measurement result to both parties in the transaction when installed as intended. When critical in case of direct sales, any ticket provided to the consumer by an ancillary device not complying with the appropriate requirements of these Regulations shall bear appropriate restrictive information.

10

Whether or not a regulated measuring instrument intended for utility measurement purposes can be remotely read it shall in any case be fitted with a metrologically controlled display accessible without tools to the consumer. The reading of this display is the measurement result that serves as the basis for the price to pay.

Further processing of data to conclude the trading transaction

11

A regulated measuring instrument other than a utility measuring instrument shall record by a durable means the measurement result accompanied by information to identify the particular transaction, when:

(a) the measurement is non-repeatable; and

(b) the regulated measuring instrument is normally intended for use in the absence of one of the trading parties.

11

Additionally, a durable proof of the measurement result and the information to identify the transaction shall be available on request at the time the measurement is concluded.

Conformity evaluation

12

A regulated measuring instrument shall be designed so as to allow ready evaluation of its conformity with the appropriate requirements of these Regulations.

SCHEDULE 1B — CONFORMITY ASSESSMENT PROCEDURES (Annex II to the Directive)

MODULE A2: — INTERNAL PRODUCTION CONTROL PLUS SUPERVISED INSTRUMENT CHECKS AT RANDOM INTERVALS

1

Internal production control plus supervised instrument checks at random intervals is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3, 4, and 5, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned satisfy the requirements of these Regulations that apply to them.

Technical documentation

2

The manufacturer shall establish the technical documentation set out in regulations 44 and 45. 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.

Manufacturing

3

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured instruments with the technical documentation referred to in paragraph 2 and with the requirements of these Regulations that apply to them.

Instrument checks

4

At the choice of the manufacturer, either an accredited in-house body or an approved body, chosen by the manufacturer, shall carry out instrument checks or have them carried out at random intervals determined by the body, in order to verify the quality of the internal checks of the instrument, taking into account, inter alia, the technological complexity of the instruments and the quantity of production. An adequate sample of the final regulated measuring instruments, taken on site by the body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the designated standard, and/or normative document, and/or equivalent tests set out in other relevant technical specifications, shall be carried out to verify the conformity of the instruments with the relevant requirements of these Regulations. In the absence of a relevant designated standard or normative document, the accredited in-house body or approved body concerned shall decide on the appropriate tests to be carried out.

Conformity marking and declaration of conformity

5

The manufacturer shall affix the UK marking and the M marking set out in these Regulations to each individual instrument that satisfies the applicable requirements of these Regulations.

5

The manufacturer shall draw up a written declaration of conformity for an instrument model and keep it together with the technical documentation at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument for which it was drawn up.

Authorised representative

6

The manufacturer's obligations set out in paragraph 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility provided that they are specified in the mandate.

MODULE B — TYPE EXAMINATION

1

‘Type examination’ is the part of a conformity assessment procedure in which an approved 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

Type examination may be carried out in either of the following manners:

(a) examination of a specimen, representative of the production envisaged, of the complete regulated measuring instrument (production type),

(b) assessment of the adequacy of the technical design of the instrument through examination of the technical documentation and supporting evidence referred to in paragraph 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the instrument (combination of production type and design type);

(c) assessment of the adequacy of the technical design of the instrument through examination of the technical documentation and supporting evidence referred to in paragraph 3, without examination of a specimen (design type).

3

The manufacturer shall lodge an application for type examination with a single approved body of his choice.

4

The approved body shall:

4

examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the instrument;

4

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 designated standards and/or normative documents, as well as the elements which have been designed in accordance with other relevant technical specifications;

4

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 designated standards and normative documents, these have been applied correctly;

4

carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant designated standards, and/or normative documents have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential requirements of these Regulations;

4

agree with the manufacturer on the location where the examinations and tests will be carried out.

4

examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the other parts of the regulated measuring instrument.

5

The approved body shall draw up an evaluation report that records the activities undertaken in accordance with paragraph 4 and their outcomes. Without prejudice to its obligations vis-à-vis the Secretary of State, the approved body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

6

Where the type meets the requirements of these Regulations, the approved body shall issue a 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 type examination certificate may have one or more annexes attached.

7

The approved body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of these Regulations, and shall determine whether such changes require further investigation. If so, the approved body shall inform the manufacturer accordingly.

8

The manufacturer shall inform the approved body that holds the technical documentation relating to the 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 type examination certificate.

9

Each approved body shall inform the Secretary of State concerning the type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.

10

The manufacturer shall keep a copy of the type examination certificate, its annexes and additions together with the technical documentation at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market.

11

The manufacturer's authorised representative may lodge the application referred to in paragraph 3 and fulfil the obligations set out in paragraphs 8 and 10, provided that they are specified in the mandate.

MODULE D: — CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

1

Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned are in conformity with the type described in the type examination certificate and satisfy the requirements of these Regulations that apply to them.

Manufacturing

2

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the regulated measuring instruments concerned as specified in paragraph 3 and shall be subject to surveillance as specified in paragraph 4.

Quality system

3

The manufacturer shall lodge an application for assessment of his quality system with an approved body of his choice, for the regulated measuring instruments concerned.

3

The quality system shall ensure that the regulated measuring instruments are in conformity with the type described in the type examination certificate and comply with the requirements of these Regulations that apply to them.

3

The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2.

3

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

The manufacturer shall keep the approved body that has approved the quality system informed of any intended change of the quality system.

Surveillance under the responsibility of the approved body

4

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4

The manufacturer shall, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:

(a) the quality system documentation;

(b) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned.

4

The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

4

In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved 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 approved body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

Conformity marking and declaration of conformity

5

The manufacturer shall affix the UK marking and the M marking set out in these Regulations and, under the responsibility of the approved body referred to in paragraph 3.1, the latter's identification number to each individual regulated measuring instrument that is in conformity with the type described in the type examination certificate and satisfies the applicable requirements of these Regulations.

5

The manufacturer shall draw up a written declaration of conformity for each instrument model and keep it at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument model for which it has been drawn up.

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 market surveillance authorities:

(a) the documentation referred to in paragraph 3.1,

(b) the information relating to the change referred to in paragraph 3.5, as approved;

7

Each approved body shall inform the Secretary of State of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted.

Authorised representative

8

The manufacturer's obligations set out in paragraphs 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

MODULE D1: — QUALITY ASSURANCE OF THE PRODUCTION PROCESS

1

Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 4 and 7, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned satisfy the requirements of these Regulations that apply to them.

Technical documentation

2

3

The manufacturer shall keep the technical documentation at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market.

Manufacturing

4

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the regulated measuring instruments concerned as specified in paragraph 5 and shall be subject to surveillance as specified in paragraph 6.

Quality system

5

The manufacturer shall lodge an application for assessment of his quality system with an approved body of his choice, for the measuring instruments concerned.

5

The quality system shall ensure compliance of the regulated measuring instruments with the requirements of these Regulations that apply to them.

5

The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 5.2.

5

The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

5

The manufacturer shall keep the approved body that has approved the quality system informed of any intended change of the quality system.

Surveillance under the responsibility of the approved body

6

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

6

(a) the quality system documentation;

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

(c) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned.

6

The approved 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

Conformity marking and declaration of conformity

7

The manufacturer shall affix the UK marking, the M marking set out in these Regulations, and, under the responsibility of the approved body referred to in paragraph 5.1, the latter's identification number to each individual regulated measuring instrument that satisfies the applicable requirements of these Regulations.

7

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 market surveillance authorities:

(a) the documentation referred to in paragraph 5.1;

(b) the information relating to the change referred to in paragraph 5.5, as approved;

9

Authorised representative

10

The manufacturer's obligations set out in paragraphs 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

MODULE E: — CONFORMITY TO TYPE BASED ON INSTRUMENT QUALITY ASSURANCE

1

Conformity to type based on instrument quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned are in conformity with the type described in the type examination certificate and satisfy the requirements of these Regulations that apply to them.

Manufacturing

2

The manufacturer shall operate an approved quality system for final product inspection and testing of the regulated measuring instruments concerned as specified in paragraph 3 and shall be subject to surveillance, as specified in paragraph 4.

Quality system

3

The manufacturer shall lodge an application for assessment of his quality system with an approved body of his choice, for the regulated measuring instruments concerned.

3

The quality system shall ensure compliance of the regulated measuring instruments with the type described in the type examination certificate and with the applicable requirements of these Regulations.

3

The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2.

3

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

The manufacturer shall keep the approved body that has approved the quality system informed of any intended change to the quality system.

Surveillance under the responsibility of the approved body

4

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4

(a) the quality system documentation;

(b) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned.

4

The approved 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

Conformity marking and declaration of conformity

5

The manufacturer shall affix the UK marking, the M marking set out in these Regulations, and, under the responsibility of the approved body referred to in paragraph 3.1, the latter's identification number to each individual instrument that is in conformity with the type described in the type examination certificate and satisfies the applicable requirements of these Regulations.

5

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 market surveillance authorities:

(a) the documentation referred to in paragraph 3.1;

7

Authorised representative

8

MODULE E1: — QUALITY ASSURANCE OF FINAL INSTRUMENT INSPECTION AND TESTING

1

Quality assurance of final instrument inspection and testing is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 4 and 7, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned satisfy the requirements of these Regulations that apply to them.

Technical documentation

2

3

The manufacturer shall keep the technical documentation at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market.

Manufacturing

4

The manufacturer shall operate an approved quality system for final product inspection and testing of the regulated measuring instruments concerned as specified in paragraph 5 and shall be subject to surveillance as specified in paragraph 6.

Quality system

5

The manufacturer shall lodge an application for assessment of his quality system with the approved body of his choice, for the regulated measuring instruments concerned.

5

The quality system shall ensure compliance of the regulated measuring instruments with the requirements of these Regulations that apply to them.

5

The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 5.2.

5

The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

5

The manufacturer shall keep the approved body that has approved the quality system informed of any intended change to the quality system.

Surveillance under the responsibility of the approved body

6

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

6

(a) the quality system documentation;

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

(c) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned.

6

The approved 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

Conformity marking and declaration of conformity

7

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 market surveillance authorities:

(a) the documentation referred to in paragraph 5.1,

(b) the information relating to the change referred to in paragraph 5.5, as approved;

9

Authorised representative

10

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 paragraphs 2, 5.1 and 6, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned, which have been subject to the provisions of paragraph 3, are in conformity with the type described in the type examination certificate and satisfy the requirements of these Regulations that apply to them.

Manufacturing

2

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured regulated measuring instruments with the approved type described in the type examination certificate and with the requirements of these Regulations that apply to them.

Verification

3

An approved body chosen by the manufacturer shall carry out the appropriate examinations and tests, or have them carried out, to verify the conformity of the instruments with the type as described in the type examination certificate and the appropriate requirements of these Regulations.

4

Verification of conformity by examination and testing of every instrument

4

All regulated measuring instruments shall be individually examined and appropriate tests set out in the relevant designated standard(s) and/or normative documents, and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the approved type described in the type examination certificate and with the appropriate requirements of these Regulations.

4

The approved 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.

Statistical verification of conformity

5

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present his regulated measuring instruments for verification in the form of homogeneous lots.

5

A random sample shall be taken from each lot according to the requirements of paragraph 5.3. All regulated measuring instruments in a sample shall be individually examined and appropriate tests set out in the relevant designated standard(s) and/or normative document(s), and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the type described in the type examination certificate and with the applicable requirements of these Regulations, and to determine whether the lot is accepted or rejected. In the absence of such designated standard or normative document, the approved body concerned shall decide on the appropriate tests to be carried out.

5

The statistical procedure shall meet the following requirements:

5

If a lot is accepted, all regulated measuring instruments of the lot shall be considered approved, except for those regulated measuring instruments from the sample that have been found not to satisfy the tests.

5

If a lot is rejected, the approved body shall take appropriate measures to prevent the placing on the market of that lot. In the event of frequent rejection of lots the approved body may suspend the statistical verification and take appropriate measures.

Conformity marking and declaration of conformity

6

The manufacturer shall affix the UK marking and the M marking set out in these Regulations, and, under the responsibility of the approved body referred to in paragraph 3, the latter's identification number to each individual instrument that is in conformity with the approved type described in the type examination certificate and satisfies the applicable requirements of these Regulations.

6

7

If the approved body agrees and under its responsibility, the manufacturer may affix the approved body's identification number to the regulated measuring instruments during the manufacturing process.

Authorised representative

8

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 paragraphs 2 and 5.1.

MODULE F1: — CONFORMITY BASED ON PRODUCT VERIFICATION

1

Conformity based on product verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3, 6.1 and 7 and ensures and declares on his sole responsibility that the regulated measuring instruments concerned which have been subject to the provisions of paragraph 4, are in conformity with the requirements of these Regulations that apply to them.

Technical documentation

2

Manufacturing

3

Verification

4

An approved body chosen by the manufacturer shall carry out the appropriate examinations and tests, or have them carried out, to verify the conformity of the regulated measuring instruments with the applicable requirements of these Regulations.

Verification of conformity by examination and testing of every instrument

5

All regulated measuring instruments shall be individually examined and appropriate tests, set out in the relevant designated standards and/or normative documents, and/or equivalent tests set out in other relevant technical specifications, shall be carried out to verify their conformity with the requirements that apply to them. In the absence of such a designated standard, or normative document, the approved body concerned shall decide on the appropriate tests to be carried out.

5

Statistical verification of conformity

6

The manufacturer shall take all measures necessary so that the manufacturing process ensures the homogeneity of each lot produced, and shall present his regulated measuring instruments for verification in the form of homogeneous lots.

6

A random sample shall be taken from each lot according to the requirements of paragraph 6.4.

6

All regulated measuring instruments in the sample shall be individually examined and appropriate tests set out in the relevant designated standards and/or normative documents, and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify their conformity with the applicable requirements of these Regulations and to determine whether the lot is accepted or rejected. In the absence of such designated standard, or normative document, the approved body concerned shall decide on the appropriate tests to be carried out.

6

The statistical procedure shall meet the following requirements:

6

Conformity marking and declaration of conformity

7

The manufacturer shall affix the UK marking and the M marking set out in these Regulations, and under the responsibility of the approved body referred to in paragraph 4, the latter's identification number to each individual regulated measuring instrument that satisfies the applicable requirements of these Regulations.

7

8

If the approved body agrees and under its responsibility, the manufacturer may affix the approved body's identification number to the regulated measuring instruments during the manufacturing process.

9

Authorised representative

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 paragraphs 2, 3 and 5 and ensures and declares on his sole responsibility that the instrument concerned, which has been subject to the provisions of paragraph 4, is in conformity with the requirements of these Regulations that apply to it.

Technical documentation

2

The manufacturer shall establish the technical documentation and make it available to the approved body referred to in paragraph 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.

Manufacturing

3

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.

Verification

4

An approved body chosen by the manufacturer shall carry out the appropriate examinations and tests set out in the relevant designated standards, and/or normative documents, or equivalent tests set out in other relevant technical specifications, to verify the conformity of the instrument with the applicable requirements of these Regulations, or have them carried out. In the absence of such a designated standard, or normative document, the approved body concerned shall decide on the appropriate tests to be carried out.

Conformity marking and declaration of conformity

5

The manufacturer shall affix the UK marking and the M marking set out in these Regulations and, under the responsibility of the approved body referred to in paragraph 4, the latter's identification number to each instrument that satisfies the applicable requirements of these Regulations.

5

The manufacturer shall draw up a written declaration of conformity and keep it at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument for which it has been drawn up.

Authorised representative

6

The manufacturer's obligations set out in paragraphs 2 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

MODULE H: — CONFORMITY BASED ON FULL QUALITY ASSURANCE

1

Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned satisfy the requirements of these Regulations that apply to them.

Manufacturing

2

The manufacturer shall operate an approved quality system for design, manufacture and final product inspection and testing of the regulated measuring instruments concerned as specified in paragraph 3, and shall be subject to surveillance as specified in paragraph 4.

Quality system

3

The manufacturer shall lodge an application for assessment of his quality system with the approved body of his choice, for the regulated measuring instruments concerned.

3

The quality system shall ensure compliance of the regulated measuring instruments with the requirements of these Regulations that apply to them.

3

The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2.

3

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

The manufacturer shall keep the approved body that has approved the quality system informed of any intended change to the quality system.

Surveillance under the responsibility of the approved body

4

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4

The manufacturer shall, for assessment purposes, allow the approved body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:

(a) the quality system documentation;

(b) the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests.;

(c) the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned.

4

The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

4

In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out instrument tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

Conformity marking and declaration of conformity

5

The manufacturer shall affix the UK marking, the M marking set out in these Regulations and, under the responsibility of the approved body referred to in paragraph 3.1, the latter's identification number to each individual instrument that satisfies the applicable requirements of these Regulations.

5

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 market surveillance authorities:

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

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

(d) the decisions and reports of the approved body referred to in paragraphs 3.5, 4.3 and 4.4.

7

Authorised representative

8

MODULE H1: — CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION

1

Conformity based on full quality assurance plus design examination is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 6, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned satisfy the requirements of these Regulations that apply to them.

Manufacturing

2

Quality system

3

The manufacturer shall lodge an application for assessment of the quality system with the approved body of his choice for the regulated measuring instruments concerned.

3

The quality system shall ensure compliance of the regulated measuring instruments with the requirements of these Regulations that apply to them.

3

The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 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 designated standard.

3

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

The manufacturer shall keep the approved body that has approved the quality system informed of any intended change to the quality system.

3

Each approved body shall inform the Secretary of State of quality system approvals issued or withdrawn, and shall periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted.

Design examination

4

The manufacturer shall lodge an application for examination of the design with the approved body referred to in paragraph 3.1.

4

The application shall make it possible to understand the design, manufacture and operation of the instrument, and to assess the conformity with the requirements of these Regulations that apply to it.

4

The approved body shall examine the application, and where the design meets the requirements of these Regulations that apply to the instrument it shall issue a design examination certificate to the manufacturer. That certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design. That certificate may have one or more annexes attached.

4

The approved body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of these Regulations, and shall determine whether such changes require further investigation. If so, the approved body shall inform the manufacturer accordingly.

4

Each approved body shall inform the Secretary of State of the design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.

4

The manufacturer shall keep a copy of the design examination certificate, its annexes and additions with the technical documentation at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market.

Surveillance under the responsibility of the approved body

5

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

5

(a) the quality system documentation;

(b) the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.;

(c) the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

5

The approved 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.

5

In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out instrument tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

Conformity marking and declaration of conformity

6

The manufacturer shall affix the UK marking and the M marking set out in these Regulations, and, under the responsibility of the approved body referred to in paragraph 3.1, the latter's identification number to each individual instrument that satisfies the applicable requirements of these Regulations.

6

7

The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the market surveillance authorities:

(a) the documentation concerning the quality system referred to in paragraph 3.1,

(b) the information relating to the change referred to in paragraph 3.5, as approved;

Authorised representative

8

The manufacturer's authorised representative may lodge the application referred to in paragraphs 4.1 and 4.2 and fulfil the obligations set out in paragraphs 3.1, 3.5, 4.4, 4.6, 6 and 7, on his behalf and under his responsibility, provided that they are specified in the mandate.

SCHEDULE 1C — WATER METERS (MI-001) (Annex III to the Directive)

The relevant requirements of Schedule 1A, the specific requirements of this Schedule and the conformity assessment procedures listed in this Schedule, apply to water meters intended for the measurement of volumes of clean, cold or heated water in residential, commercial and light industrial use.

Rated Operating Conditions

1

The flowrate range of the water.

2

The temperature range of the water.

3

The relative pressure range of the water, the range being 0.3 bar to at least 10 bar at Q₃.

4

For the power supply: the nominal value of the AC voltage supply and/or the limits of DC supply.

5

The MPE, positive or negative, on volumes delivered at flowrates between the transitional flowrate (Q₂) (included) and the overload flowrate (Q₄) is:

6

The MPE, positive or negative, on volumes delivered at flowrates between the minimum flowrate (Q₁) and the transitional flowrate (Q₂) (excluded) is 5 % for water having any temperature.

Electromagnetic immunity

7

The effect of an electromagnetic disturbance on a water meter shall be such that:

— the change in the measurement result is no greater than the critical change value as defined in paragraph 7.1.3, or

— the indication of the measurement result is such that it cannot be interpreted as a valid result, such as a momentary variation that cannot be interpreted, memorised or transmitted as a measuring result.

7

After undergoing an electromagnetic disturbance the water meter shall:

— recover to operate within MPE, and

— have all measurement functions safeguarded, and

— allow recovery of all measurement data present just before the disturbance.

7

The critical change value is the smaller of the two following values:

— the volume corresponding to half of the magnitude of the MPE in the upper zone on the measured volume;

— the volume corresponding to the MPE on the volume corresponding to one minute at flowrate Q₃.

Durability

7

After an appropriate test, taking into account the period of time estimated by the manufacturer, has been performed, the following criteria shall be satisfied:

7

The variation of the measurement result after the durability test, when compared with the initial measurement result, shall not exceed:

— 3 % of the metered volume between Q₁ included and Q₂ excluded;

— 1.5 % of the metered volume between Q₂ included and Q₄ included.

7

The error of indication for the volume metered after the durability test shall not exceed:

— ± 6 % of the metered volume between Q₁ included and Q₂ excluded;

— ± 2.5 % of the metered volume between Q₂ included and Q₄ included for water meters intended to meter water with a temperature between 0.1 °C and 30 °C,

Suitability

8

The meter shall be able to be installed to operate in any position unless clearly marked otherwise.

8

The manufacturer shall specify whether the meter is designed to measure reverse flow. In such a case, the reverse flow volume shall either be subtracted from the cumulated volume or shall be separately recorded. The same MPE shall apply to both forward and reverse flow.

Units of Measurement

9

Metered volume shall be displayed in cubic metres.

Putting into Use

10

The requirements under paragraphs 1, 2 and 3 are determined by the utility or the person legally designated for installing the meter, so that the meter is appropriate for the accurate measurement of consumption that is foreseen or foreseeable.

SCHEDULE 1D — GAS METERS (MI-002) (Annex IV to the Directive)

The relevant requirements of Schedule 1A, the specific requirements of this Schedule and the conformity assessment procedures listed in this Schedule, apply to gas meters.

PART I — SPECIFIC REQUIREMENTS

GAS METERS

1

Rated operating conditions

1

The flowrate range of the gas shall fulfil at least the following conditions:

1

The temperature range of the gas, with a minimum range of 40 °C.

1

The gas meter shall be designed for the range of gases and supply pressures of the United Kingdom. In particular the manufacturer shall indicate:

— the gas family or group;

— the maximum operating pressure.

1

A minimum temperature range of 50 °C for the climatic environment.

1

The nominal value of the AC voltage supply and/or the limits of DC supply.

Maximum permissible error (MPEs)

2

Gas meter indicating the volume at metering conditions or mass

2

The gas meter shall not exploit the MPEs or systematically favour any party.

2

For a gas meter with temperature conversion, which only indicates the converted volume, the MPE of the meter is increased by 0.5 % in a range of 30 °C extending symmetrically around the temperature specified by the manufacturer that lies between 15 °C and 25 °C. Outside this range, an additional increase of 0.5 % is permitted in each interval of 10 °C.

Permissible effect of disturbances

3

Electromagnetic immunity

3

The effect of an electromagnetic disturbance on a gas meter shall be such that:

— the change in the measurement result is no greater than the critical change value as defined in paragraph 3.1.3, or

— the indication of the measurement result is such that it cannot be interpreted as a valid result, such as a momentary variation that cannot be interpreted, memorised or transmitted as a measuring result.

3

After undergoing a disturbance, the gas meter shall:

— recover to operate within MPE, and

— have all measurement functions safeguarded, and

— allow recovery of all measurement data present just before the disturbance.

3

The critical change value is the smaller of the two following values:

— the quantity corresponding to half of the magnitude of the MPE in the upper zone on the measured volume;

— the quantity corresponding to the MPE on the quantity corresponding to one minute at maximum flowrate.

Effect of upstream-downstream flow disturbances

3

Under installation conditions specified by the manufacturer, the effect of the flow disturbances shall not exceed one third of the MPE.

Durability

4

After an appropriate test, taking into account the period of time estimated by the manufacturer, has been performed, the following criteria shall be satisfied:

Class 1.5 Gas Meters

4

The variation of the measurement result after the durability test when compared with the initial measurement result for the flow rates in the range Qt to Qmax shall not exceed the measurement result by more than 2 %.

4

The error of indication after the durability test shall not exceed twice the MPE in paragraph 2.

Class 1.0 Gas Meters

4

The variation of the measurement result after the durability test when compared with the initial measurement result shall not exceed one-third of the MPE in paragraph 2.

4

The error of indication after the durability test shall not exceed the MPE in paragraph 2.

Suitability

5

A gas meter powered from the mains (AC or DC) shall be provided with an emergency power supply device or other means to ensure, during a failure of the principal power source, that all measuring functions are safeguarded.

5

A dedicated power source shall have a lifetime of at least five years. After 90 % of its lifetime an appropriate warning shall be shown.

5

An indicating device shall have a sufficient number of digits to ensure that the quantity passed during 8,000 hours at Qmax does not return the digits to their initial values.

5

The gas meter shall be able to be installed to operate in any position declared by the manufacturer in its installation instruction.

5

The gas meter shall have a test element, which shall enable tests to be carried out in a reasonable time.

5

The gas meter shall respect the MPE in any flow direction or only in one flow direction clearly marked.

Units

6

Metered quantity shall be displayed in cubic metre, or in kilogram.

PART II — PUTTING INTO USE AND CONFORMITY ASSESSMENT

7

Putting into use

(a) The measurement of residential use must be performed by means of any Class 1.5 gas meter, or by Class 1.0 gas meters which have a Qmax/Qmin ratio equal to or greater than 150.

(b) Measurement of commercial and/or light industrial use must be performed by any Class 1.0 or Class 1.5 gas meter.

(c) The person responsible for installing a gas meter must have regard to the requirements under paragraphs 1.2 and 1.3 of Part I of this Schedule and must ensure that the gas meter is appropriate for the accurate measurement of consumption that is foreseen or foreseeable.

CONFORMITY ASSESSMENT The conformity assessment procedures specified in the modules in Schedule 1B applicable to gas meters that the manufacturer can choose between are:

(a) B and F;

(b) B and D; or

SCHEDULE 1E — ACTIVE ELECTRICAL ENERGY METERS (MI-003) (Annex V to the Directive)

The relevant requirements of Schedule 1A, the specific requirements of this Schedule and the conformity assessment procedures listed in this Schedule, apply to active electrical energy meters.

Accuracy

1

The manufacturer shall specify the class index of the meter. The class indices are defined as: Class A, B and C.

Rated operating conditions

2

The manufacturer shall specify the rated operating conditions of the meter; in particular:

MPEs

3

The effects of the various measurands and influence quantities (a, b, c,…) are evaluated separately, all other measurands and influence quantities being kept relatively constant at their reference values. The error of measurement, that shall not exceed the MPE stated in Table 2, is calculated as:

4

Permissible effect of disturbances

4

General

Effect of disturbances of long duration

4

In the case of electromechanical electricity meters, no critical change values are defined for harmonic contents in the current circuits and for DC and harmonics in the current circuit.

Permissible effect of transient electromagnetic phenomena

4

The effect of an electromagnetic disturbance on an electrical energy meter shall be such that during and immediately after a disturbance:

and in reasonable time after the disturbance the meter shall:

— recover to operate within the MPE limits, and

— have all measurement functions safeguarded, and

— allow recovery of all measurement data present prior to the disturbance, and

— not indicate a change in the registered energy of more than the critical change value.

4

For overcurrent the critical change value is 1.5 %.

Suitability

5

Below the rated operating voltage the positive error of the meter shall not exceed 10 %.

5

The display of the total energy shall have a sufficient number of digits to ensure that when the meter is operated for 4,000 hours at full load (I = Imax, U = Uₙ and PF = 1) the indication does not return to its initial value and shall not be able to be reset during use.

5

In the event of loss of electricity in the circuit, the amounts of electrical energy measured shall remain available for reading during a period of at least 4 months.

Running with no load

5

When the voltage is applied with no current flowing in the current circuit (current circuit shall be open circuit), the meter shall not register energy at any voltage between 0.8 ∙ Uₙ and 1.1 Uₙ.

Starting

5

The meter shall start and continue to register at Uₙ, PF = 1 (polyphase meter with balanced loads) and a current which is equal to Ist.

Units

6

The electrical energy measured shall be displayed in kilowatt-hours or in megawatt-hours.

Putting into use

7

(a) Subject to sub-paragraph (b), measurement may be performed by means of any active electrical energy meter provided that the temperature range to which an active electrical energy meter is exposed is not wider than the range specified by the manufacturer in relation to that active electrical energy meter in accordance with paragraph 1.3.1 and Table 1 in Schedule 1A to these Regulations.

(b) Class A active electrical energy meters may not be used when operating outside the temperature range of an upper temperature limit of 30°C to a lower temperature limit of 5°C.

(c) The person responsible for installing the active electrical energy meter must determine the correct current range and assess the climatic environment.

SCHEDULE 1F — MEASURING SYSTEMS FOR THE CONTINUOUS AND DYNAMIC MEASUREMENT OF QUANTITIES OF LIQUIDS OTHER THAN WATER (MI-005) (Annex VII to the Directive)

The relevant essential requirements of Schedule 1A, the specific requirements of this Schedule and the conformity assessment procedures listed in this Schedule, apply to measuring systems intended for the continuous and dynamic measurement of quantities (volumes or masses) of liquids other than water. If appropriate, the terms ‘volume, and L’ in this Schedule can be read as: ‘mass and kg’.

Rated operating conditions

1

The manufacturer shall specify the rated operating conditions for the instrument, in particular;

The flowrate range

1

The flowrate ran ge is subject to the following conditions:

(i) the flowrate range of a measuring system shall be within the flowrate range of each of its elements, in particular the meter.

(ii) meter and measuring system:

Specific measuring system	Characteristic of liquid	Minimum ratio of Qmax: Qmin
Fuel dispensers	Not Liquefied gases	10: 1
Fuel dispensers	Liquefied gases	5: 1
Measuring system	Cryogenic liquids	5: 1
Measuring systems on pipeline and systems for loading ships	All liquids	Suitable for use
All other measuring systems	All liquids	4: 1

1

The properties of the liquid to be measured by the instrument by specifying the name or type of the liquid or its relevant characteristics, for example:

— Temperature range;

— Pressure range;

— Density range;

— Viscosity range.

1

The nominal value of the AC voltage supply and/or limits of the DC voltage supply.

1

The base conditions for converted values.

Accuracy classification and maximum permissible errors (MPEs)

2

For quantities equal to or greater than 2 litres the MPE on indications is:

2

For quantities less than two litres the MPE on indications is:

2

However, no matter what the measured quantity may be, the magnitude of the MPE is given by the greater of the following two values:

— the absolute value of the MPE given in Table 2 or Table 3,

— the absolute value of the MPE for the minimum measured quantity (Emin).

2

For minimum measured quantities greater than or equal to 2 litres the following conditions apply:

2

For minimum measured quantities of less than two litres, the above mentioned condition 1 applies and Emin is twice the value specified in Table 3, and related to line A of Table 2.

Converted indication

2

In the case of a converted indication the MPEs are as in line A of Table 2.

Conversion devices

2

MPEs on converted indications due to a conversion device are equal to ± (A — B), A and B being the values specified in Table 2.

2

The requirement (a) in paragraph 2.6 applies to any calculation, not only conversion.

2

The measuring system shall not exploit the MPEs or systematically favour any party.

Maximum permissible effect of disturbances

3

The effect of an electromagnetic disturbance on a measuring system shall be one of the following:

— the change in the measurement result is not greater than the critical change value as defined in paragraph 3.2, or

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