The Measuring Instruments Regulations 2016

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);

• (c) the European Telecommunications Standards Institute (ETSI);

• (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;

• (c) draws up the technical documentation referred to in Article 18;

• (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

• (c) regulations 36 to 39 do not apply.

• (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

• (c) the measuring instrument bears the CE marking, and the supplementary metrology marking referred to in Article 21(2).

• (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;

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

• (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

• (c) any reference to “designated standard” in regulation 45(1)(f) is to be read as a reference to “harmonised standard.

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);

• (c) “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 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;

• (c) draws up the technical documentation referred to in Article 18; and

• (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;

• (c) regulation 52(10) is to be read as if the words beginning with “and” and ending with “body” were omitted;

• (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

• (c) an importer has complied with the obligations set out in paragraph (3).

• (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;

• (c) critical change values; and

• (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

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

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

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

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:

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

• (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;

• (c) the upper and lower temperature limit, whether condensation is possible or not, open or closed location;

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

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