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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[^key-7f98f464c4376fe6c29aa80171d401e7]: Word in Sch. 3 para. 2A(7)(c) substituted (1.10.2024) by The Product Safety and Metrology etc. (Amendment) Regulations 2024 (S.I. 2024/696), regs. 1(2), 18(5)(b) (with reg. 23)

[^key-d2674808fb47196b801b4bd86818b0bd]: Word in reg. 2(1A) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 6 para. 12

Designated standard

2A

(1) Subject to paragraphs (6) and (7), in these Regulations a “designated standard” means a technical specification which is—

(a) adopted by a recognised standardisation body or an international standardising body, for repeated or continuous application, with which compliance is not compulsory; and

(b) designated by the Secretary of State by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate.

(2) For the purposes of paragraph (1), a “technical specification” means a document that prescribes technical requirements to be fulfilled by a regulated measuring instrument, process, service or system and which lays down one or more of the following—

(a) the characteristics required of a regulated measuring instrument, including—

(i) levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, and

(ii) the requirements applicable to the regulated measuring instrument as regards the name under which the regulated measuring instrument is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; and

(b) production methods and processes relating to the regulated measuring instrument, where these have an effect on the characteristics of the regulated measuring instrument.

(3) For the purposes of this regulation a “recognised standardisation body” means any one of the following organisations—

(a) the European Committee for Standardisation (CEN);

(b) the European Committee for Electrotechnical Standardisation (Cenelec);

(d) the British Standards Institution (BSI).

(3A) In this regulation “international standardising body” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time).

(4) When considering whether the manner of publication of a reference is appropriate in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.

(5) Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with such technical specifications adopted by the other recognised standardisation bodies or by international standardising bodies as the Secretary of State considers to be relevant.

(6) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b).

(7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.

(8) The Secretary of State may by regulations amend paragraph (3) to reflect any changes in the name or structure of the recognised standardisation bodies.

(9) Regulations made under paragraph (8) are to be made by statutory instrument.

(10) A statutory instrument containing regulations made under paragraph (9) is subject to annulment in pursuance of a resolution of either House of Parliament.

Meaning of “regulated measuring instrument” ... and application of these Regulations

Revocations and transitional and consequential provisions

Exception for trade fairs, exhibitions and demonstration

Obligations which are met by complying with obligations in the Directive

33A

(1) In this regulation—

(a) any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive;

(b) “CE marking” has the meaning given to it in Article 4(22);

(c) “Module B” means the conformity assessment procedure set out under the heading “MODULE B: EU-TYPE EXAMINATION” in Annex II;

(d) “Module H1” means the conformity assessment procedure set out under the heading “MODULE H1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION” in Annex II;

(e) “EU-design examination certificate” means an EU design certificate issued in accordance with Module H1;

(f) “EU-type examination certificate” means an EU-type examination certificate issued in accordance with Module B;

(g) “harmonised standard” has the meaning given to it in Article 4(14);

(h) “instrument-specific Annexes” means Annexes III to XII.

(2) Paragraph (3) applies where, before placing a regulated measuring instrument on the market, the manufacturer—

(a) ensures that the regulated measuring instrument has been designed and manufactured in accordance with the essential requirements set out in Annex I and in the relevant instrument-specific Annex which applies to the regulated measuring instrument;

(b) ensures that the one of the relevant conformity assessment procedures listed in the relevant instrument-specific Annex that apply to that regulated measuring instrument in accordance with Article 17 have been carried out;

(d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English;

(e) affixes a CE marking and the supplementary metrology marking, in accordance with Articles 21 and 22(1) to (6);

(f) draws up an EU declaration of conformity, in accordance with Article 19; and

(g) ensures that the EU declaration of conformity is prepared in or translated into English.

(3) Where this paragraph applies—

(a) the requirements of regulations 7(a) to (e), 48 and 52(2) are to be treated as being satisfied;

(b) regulations 8, 9(2), 51, 68(1)(a) to (e), 72, 73 and 75 apply subject to the modifications in paragraph (8); and

(4) Paragraph (5) applies where, before placing a regulated measuring instrument on the market, the importer ensures that—

(a) the relevant conformity assessment procedures that apply to that measuring instrument in accordance with Article 17 have been carried out;

(b) the manufacturer has drawn up the technical documentation referred to in Article 18; and

(5) Where this paragraph applies—

(a) the requirements of regulation 17(2)(a) to (c) are to be treated as being satisfied; and

(b) regulations 18, 21, 23, 51, 68(1)(a) to (e), 72, 73 and 75 apply subject to the modifications in paragraph (8).

(6) Paragraph (7) applies where, before making a regulated measuring instrument available on the market, a distributor ensures that the regulated measuring instrument bears the CE marking, and the supplementary metrology marking referred to in Article 21(2).

(7) Where this paragraph applies—

(a) regulation 28(1) is to be treated as being satisfied; and

(b) regulations 29(1),30, 68(1)(a), 68(1)(b), 72 and 73 apply subject to the modifications in paragraph (8).

(8) The modifications referred to in paragraphs (3)(b), (5)(b) and (7)(b) are that—

(a) any reference to “declaration of conformity” is to be read as a reference to the EU declaration of conformity;

(b) any reference to “UK marking” is to be read as a reference to the CE marking;

(c) except in relation to regulations 72 and 73, any reference to “essential requirements” is to be read as a reference to the essential requirements referred to in Annex I and in the relevant instrument-specific Annex which applies to the regulated measuring instrument;

(d) any reference to “designated standard” is to be read as a reference to a harmonised standard;

(e) any reference to “... conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedures that apply to the regulated measuring instrument in accordance with Article 17;

(f) any reference to “technical documentation” is a reference to the technical documentation referred to in Article 18;

(g) any reference to “type examination certificate” is to be read as a reference to an EU-type examination certificate; and

(h) any reference to “design examination certificate” is to be read as a reference to an EU-design examination certificate;

(i) any reference to “M marking” is to be read as a reference to the supplementary metrology marking; and

(j) any reference to “approved body” is to be read as a reference to the body that undertook any conformity assessment procedure in accordance with Article 13;

(k) any reference to “authorised mark” includes the CE marking and the supplementary metrology marking.

Conformity assessment procedure obligation which is met by complying with the Directive

33B

(1) In this regulation—

(a) any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive;

(b) “Module B” means the conformity assessment procedure set out under the heading “MODULE B: EU-TYPE EXAMINATION” in Annex II;

(d) “harmonised standard” has the meaning given to it in Article 4(14);

(e) “instrument-specific Annexes” means Annexes III to XII.

(2) Paragraph (3) applies where—

(a) in accordance with Article 17, one of the conformity assessment procedures listed in the instrument-specific Annex that applies to the regulated measuring instrument is Module B; and

(b) before placing a regulated measuring instrument on the market, the manufacturer ensures that—

(i) the regulated measuring instrument has been designed in accordance with the essential requirements set out in Annex I and in the relevant instrument-specific Annex which applies to the regulated measuring instrument; and

(ii) Module B has been complied with in respect of that regulated measuring instrument.

(3) Where this paragraph applies—

(a) any reference in regulation 7(c) to “relevant conformity assessment procedure” includes Module B;

(b) any reference to “type examination certificate” in regulations 45(1)(j), 72(3)(b) and 73(3)(b) is to be read as a reference to “EU-type examination certificate”; and

Expiry of regulations 33A and 33B

33C

(1) In this regulation—

(a) any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive;

(b) “harmonised standard” has the meaning given to it in Article 4(14);

(2) Paragraph (3) applies where, before placing a regulated measuring instrument on the market, the manufacturer—

(a) ensures that the regulated measuring instrument has been designed and manufactured in accordance with the essential requirements set out in Annex I and in the relevant instrument-specific Annex which applies to the regulated measuring instrument;

(b) ensures that one of the relevant conformity assessment procedures listed in the relevant instrument-specific Annex that apply to that regulated instrument in accordance with Article 17 has been carried out;

(d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English.

(3) Where this paragraph applies—

(a) the requirements of regulations 7(1)(a) to (c), 44 and 45 are to be treated as being satisfied;

(b) except for regulations 47 to 52(1) to (7), Part 4 does not apply;

(c) regulations 8, 9, 15, 17(2)(a) and (b), 18, 21, 24, 29, 30, 51, 63, 68 and 76 apply subject to the modifications in paragraph (4);

(d) regulation 47 and Schedule 1K apply subject to the modifications in paragraphs (4) and (5);

(e) regulations 48, 52, 72 and 73 apply subject to the modifications in paragraph (5).

(4) The modifications referred to in paragraph (3)(c) and (d) are that—

(a) any reference to “essential requirements” is to be read as a reference to the essential requirements referred to in Annex I and in the relevant instrument-specific Annex which applies to the regulated measuring instrument;

(b) any reference to “designated standard” is to be read as a reference to a harmonised standard;

(c) any reference to “conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedure that applies to the regulated measuring instrument in accordance with Article 17;

(d) any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Article 18.

(5) The modifications referred to in paragraph (3)(d) and (e) are that—

(a) in regulations 47(1)(b) and 52 any reference to “Schedule 1B” is to be read as a reference to Annex II;

(b) in regulation 48 any reference to “enactment” is to be read as including the Directive;

(d) in regulations 72(3)(b) and 73(3)(b)—

(i) any reference to “type examination certificate” is to be read as a reference to an EU-type examination certificate issued under the conformity assessment procedure set out under the heading “MODULE B: EU TYPE EXAMINATION” in Annex II;

(ii) any reference to “design examination certificate” is to be read as a reference to an EU-design examination certificate issued in accordance with the conformity assessment procedure set out under the heading “MODULE H1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION” in Annex II.

(e) in Schedule 1K—

(i) in paragraph 5 the reference to “relevant statutory requirements” is to be read as including the Directive;

(ii) in paragraph 7 the reference to “approved body” is to be read as a reference to any conformity assessment body that undertook a conformity assessment procedure in respect of the regulated measuring instrument in accordance with Article 17.

Qualifying Northern Ireland Goods

33D

(1) Where paragraph (2) applies—

(a) a regulated measuring instrument is to be treated as being in conformity with the essential requirements; and

(b) each relevant economic operator is to be treated as having complied or as complying with the obligations imposed on them under Part 2.

(2) This paragraph applies where—

(a) a regulated measuring instrument is—

(i) in conformity with the essential requirements, within the meaning of that term in regulation 2, as it applies in Northern Ireland; and

(ii) qualifying Northern Ireland goods; and

(b) each relevant economic operator has complied or is complying with the obligations imposed on them under Part 2, as that Part applies in Northern Ireland; and

(3) The obligations referred to in paragraph (2)(c) are that, before placing the non-automatic weighing instrument on the market, the importer—

(a) complies with regulation 19;

(b) ensures that—

(i) the relevant conformity assessment procedure has been carried out.

(ii) the manufacturer has drawn up the technical documentation; and

(iii) the regulated measuring instrument bears the CE marking.

(3A) After a regulated measuring instrument has been placed on the market pursuant to this regulation, regulations 72 and 73 are to be read in relation to that instrument subject to the following modifications—

(a) the reference in regulation 72(2)(a) to “UK marking” is to be read as a reference to the CE marking, within the meaning of regulation 2(1) as it applies in Northern Ireland;

(b) the reference in regulation 72(2)(b) to “M marking”, is to be read as a reference to the M Marking as defined in regulation 2(1) as it applies in Northern Ireland;

(c) the reference in regulation 72(2)(c) to “approved body” is to be read as a reference to a “notified body” as defined in regulation 2(1) as it applies in Northern Ireland;

(d) the references in regulations 72(3)(a) and 73(3)(a) to “essential requirements” are to be read as the essential requirements within the meaning of that term in regulation 2(1) as it applies in Northern Ireland; and

(e) the references in regulations 72(3)(b) and 73(3)(b) to “type examination certificate” is to be read as a reference to an EU-type examination certificate as defined in regulation 2(1) as it applies in Northern Ireland.

(4) In this regulation—

“CE marking” has the meaning given it in in regulation 2(1), as it applies in Northern Ireland;

“qualifying Northern Ireland goods” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;

“relevant conformity assessment procedure” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland;

“technical documentation” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland.

Presumptions of conformity of regulated measuring instruments

Power to amend Schedules 1C to 1J

39A

(1) Where the one or more of the conditions in paragraph (2) are met, the Secretary of State may by regulations make provision to amend Schedules 1C to 1J in relation to any of the following matters—

(a) maximum permissible errors (MPEs) and accuracy classes;

(b) rated operating conditions;

(d) disturbances.

(2) The conditions referred to in paragraph (1) are that the Secretary of State considers that the purpose of the provision is to—

(a) take into account scientific or technical progress; or

(b) provide adequate protection of consumers or other end users.

(3) The power to make regulations under this regulation includes the power—

(a) to make different provision for different cases; and

(b) to make such supplemental, consequential and transitional provision as the Secretary of State considers appropriate

(4) Regulations made under paragraph (1) are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.

Capacity serving measures - accredited in house bodies

Subsidiaries and contractors

Fees

Form and contents of ... declaration of conformity etc.

Regulated measuring instruments that require more than one declaration of conformity

Conformity with ... requirements to be indicated by the UK marking

Prohibition on improper use of the UK marking and the M marking

Rules and conditions for affixing the UK marking and the M marking

UK(NI) indication

52A

(1) Where the CE marking is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the regulated measuring instrument, in accordance with this regulation.

(2) The UK(NI) indication must be affixed—

(a) visibly, legibly and indelibly; and

(b) before the regulated measuring instrument is placed on the market in Northern Ireland.

(3) The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with regulation 52.

(4) The UK(NI) indication must be affixed by—

(a) the manufacturer; or

(b) the manufacturer's authorised representative.

(5) When placing a regulated measuring instrument on the market in Northern Ireland, an importer must ensure that the manufacturer has complied with their obligations under this regulation.

Register of notified bodies established in the United Kingdom

52B

(1) The Secretary of State must ensure that—

(a) each notified body established in the United Kingdom is assigned an identification number; and

(b) there is a register of—

(i) notified bodies established in the United Kingdom;

(ii) their notified body identification number;

(iii) the activities for which they have been notified;

(iv) any restrictions on those activities.

(2) The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available.

(3) The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b).

Approved bodies

Approval of conformity assessment bodies

Presumption of conformity of approved bodies

Monitoring

Restriction, suspension or withdrawal of approval

Register of approved bodies

UK national accreditation body

SCHEDULE 1A — ESSENTIAL REQUIREMENTS (Annex I to the Directive)

A regulated measuring instrument shall provide a high level of metrological protection in order that any party affected can have confidence in the result of measurement, and shall be designed and manufactured to a high level of quality in respect of the measurement technology and security of the measurement data.

Allowable Errors

1

Under rated operating conditions and in the absence of a disturbance, the error of measurement shall not exceed the maximum permissible error (MPE) value as laid down in the appropriate instrument-specific requirements.

1

Under rated operating conditions and in the presence of a disturbance, the performance requirement shall be as laid down in the appropriate instrument-specific requirements.

1

The manufacturer shall specify the climatic, mechanical and electromagnetic environments in which the instrument is intended to be used, power supply and other influence quantities likely to affect its accuracy, taking account of the requirements laid down in the appropriate instrument-specific Schedules.

1

Climatic environments

1

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

1

(a) Electromagnetic environments are classified into classes E1, E2 or E3 as described below, unless otherwise laid down in the appropriate instrument-specific Schedules.

1

Other influence quantities to be considered, where appropriate, are:

— voltage variation;

— mains frequency variation;

— power frequency magnetic fields;

— any other quantity likely to influence in a significant way the accuracy of the instrument.

1

When carrying out the tests as envisaged in these Regulations, the following points shall apply:

1

Basic rules for testing and the determination of errors

1

Ambient humidity

(a) According to the climatic operating environment in which the instrument is intended to be used either the damp heat-steady state (non-condensing) or damp heat cyclic (condensing) test may be appropriate.

(b) The damp heat cyclic test is appropriate where condensation is important or when penetration of vapour will be accelerated by the effect of breathing. In conditions where non-condensing humidity is a factor the damp-heat steady state is appropriate.

Reproducibility

2

The application of the same measurand in a different location or by a different user, all other conditions being the same, shall result in the close agreement of successive measurements. The difference between the measurement results shall be small when compared with the MPE.

Repeatability

3

The application of the same measurand under the same conditions of measurement shall result in the close agreement of successive measurements. The difference between the measurement results shall be small when compared with the MPE.

Discrimination and Sensitivity

4

A regulated measuring instrument shall be sufficiently sensitive and the discrimination threshold shall be sufficiently low for the intended measurement task.

Durability

5

A regulated measuring instrument shall be designed to maintain an adequate stability of its metrological characteristics over a period of time estimated by the manufacturer, provided that it is properly installed, maintained and used according to the manufacturer's instruction when in the environmental conditions for which it is intended.

Reliability

6

A regulated measuring instrument shall be designed to reduce as far as possible the effect of a defect that would lead to an inaccurate measurement result, unless the presence of such a defect is obvious.

Suitability

7

A regulated measuring instrument shall have no feature likely to facilitate fraudulent use, whereas possibilities for unintentional misuse shall be minimal.

7

A regulated measuring instrument shall be suitable for its intended use taking account of the practical working conditions and shall not require unreasonable demands of the user in order to obtain a correct measurement result.

7

The errors of a utility measuring instrument at flows or currents outside the controlled range shall not be unduly biased.

7

Where a regulated measuring instrument is designed for the measurement of values of the measurand that are constant over time, the regulated measuring instrument shall be insensitive to small fluctuations of the value of the measurand, or shall take appropriate action.

7

A regulated measuring instrument shall be robust and its materials of construction shall be suitable for the conditions in which it is intended to be used.

7

A regulated measuring instrument shall be designed so as to allow the control of the measuring tasks after the instrument has been placed on the market and put into use. If necessary, special equipment or software for this control shall be part of the instrument. The test procedure shall be described in the operation manual.

Protection against corruption

8

The metrological characteristics of a regulated measuring instrument shall not be influenced in any inadmissible way by the connection to it of another device, by any feature of the connected device itself or by any remote device that communicates with the regulated measuring instrument.

8

A hardware component that is critical for metrological characteristics shall be designed so that it can be secured. Security measures foreseen shall provide for evidence of an intervention.

8

Software that is critical for metrological characteristics shall be identified as such and shall be secured.

8

Measurement data, software that is critical for measurement characteristics and metrologically important parameters stored or transmitted shall be adequately protected against accidental or intentional corruption.

8

For utility measuring instruments the display of the total quantity supplied or the displays from which the total quantity supplied can be derived, whole or partial reference to which is the basis for payment, shall not be able to be reset during use.

Information to be borne by and to accompany the instrument

9

A regulated measuring instrument shall bear the following inscriptions:

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

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

(d) measuring capacity;

(e) measuring range;

(f) identity marking;

(g) number of the type examination certificate or the design examination certificate;

(h) information whether or not additional devices providing metrological results comply with the provisions of these Regulations on legal metrological control.

9

An instrument of dimensions too small or of too sensitive a composition to allow it to bear the relevant information shall have its packaging, if any, and the accompanying documents required by the provisions of these Regulations suitably marked.

9

The instrument shall be accompanied by information on its operation, unless the simplicity of the regulated measuring instrument makes this unnecessary. Information shall be easily understandable and shall include where relevant:

(a) rated operating conditions;

(b) mechanical and electromagnetic environment classes;

(d) instructions for installation, maintenance, repairs, permissible adjustments;

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

(f) conditions for compatibility with interfaces 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

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