The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 No. 696

Regulation 30

SCHEDULE 27Amendment of the Measuring Instruments Regulations 2016

Introduction

1. The Measuring Instruments Regulations 2016 are amended in accordance with paragraphs 2 to 53.

Amendment to regulation 2

2.—(1) Regulation 2 (interpretation) is amended as follows.

(2) In paragraph (1)—

(a)omit the definition of “accreditation”;

(b)omit the definition of “accreditation certificate”;

(c)after the definition of “active electrical energy meter”, insert—

““approved body” has the meaning given to it in regulation 53 (approved bodies);”;

(d)for the definition of “authorised representative”, substitute—

““authorised representative” means—

(a)

a person who—

(i)

immediately before exit day was established in the United Kingdom or an EEA state and was appointed by written mandate to perform specified tasks for that manufacturer, in accordance with regulation 15, as it had effect immediately before exit day; and

(ii)

on or after exit day continues to be so established and appointed by the manufacturer to perform those tasks; or

(b)

a person who, on or after exit day is appointed in accordance with regulation 15;”;

(e)omit the definition of “CE marking”;

(f)omit the definition of “Commission”;

(g)in the definition of “conformity assessment” before “measuring” insert “regulated”;

(h)after the definition of “conformity assessment body”, insert—

““declaration of conformity” means a declaration of conformity required to be drawn up in accordance with chapter 3 of Part 4;

“designated standard” has the meaning given to it in regulation 2A;

“design examination certificate” means a design certificate issued by an approved body in accordance with Module H1 in Schedule 1B ”;

(i)omit the definition of “dimensional measuring instrument”;

(j)in the definition of “distributor” before “measuring” insert “regulated”;

(k)in the definition of “essential requirements”—

(i)before “measuring” insert “regulated”;

(ii)for “1”, substitute “1A and 1C to 1J”;

(l)omit the definition of “EU declaration of conformity”;

(m)omit the definition of “EU-design examination certificate”;

(n)omit the definition of “EU-type examination certificate”;

(o)in the definition of “exhaust gas analyser” before “measuring” insert “regulated”;

(p)omit the definition of “harmonised standard”;

(q)for the definition of “importer” substitute—

““importer” means a person who—

(a)

is established in the United Kingdom; and

(b)

places a regulated measuring instrument from a country outside of the United Kingdom on the market;”;

(r)in the definition of “M marking”—

(i)before “measuring” insert “regulated”;

(ii)for “CE”, substitute “UK”;

(s)omit the definition of “measuring instrument”;

(t)in the definition of “make available on the market”—

(i)before “measuring” insert “regulated”;

(ii)for “European Economic Area” substitute, “United Kingdom”;

(u)in the definition of “manufacturer” insert “regulated” before “measuring” in each place it occurs;

(v)in the definition of “market surveillance authority”, omit from “and” to “EEA state”;

(w)omit the definition of “national accreditation body”;

(x)omit the definition of “non-prescribed measuring instrument”;

(y)omit the definition of “notified body”;

(z)omit the definition of “notified body requirements”;

(aa)omit the definition of “notifying authority”;

(bb)in the definition of “place on the market”—

(i)before “measuring” insert “regulated”;

(ii)for “European Economic Area”, substitute “United Kingdom”;

(cc)in the definition of “putting into use” insert “regulated” before “measuring”;

(dd)in the definition of “relevant conformity assessment procedure”—

(i)before “measuring” insert “regulated”;

(ii)for “Schedule 1”, substitute “Schedules 1C to 1J”;

(ee)in the definition of “relevant economic operator” insert “regulated” before “measuring” in both places it occurs;

(ff)omit the definition of “sub-assembly”;

(gg)in the definition of “taximeter” insert “regulated” before “measuring”;

(hh)in the definition of “technical specification” insert “regulated” before “measuring”;

(ii)after the definition of “technical specification” insert—

““type examination certificate” means a type examination certificate issued by an approved body in accordance with Module B in Schedule 1B;

“UK marking” means the marking in the form set out in Annex 2 of RAMS;

“UK national accreditation body” means the body appointed by the Secretary of State in accordance with Article 4 of RAMS;”;

(jj)omit the definition of “thermal energy meter”;

(kk)omit the definition of “Union harmonisation legislation”;

(ll)omit the definition of “United Kingdom Accreditation Service”;

(mm)omit the definition of “volume conversion device”;

(nn)in the definition of “withdraw” insert “regulated” before “measuring” in both places it occurs.

(3) After paragraph (1) insert—

“(1A) Schedules 1A to 1J reproduce the provisions of Annexes I to V, VII to X and XII to the Directive (respectively) with amendments to correct deficiencies in retained EU law.

(1B) A reference to a provision of Schedules 1A to 1J is a reference to the equivalent provision of the relevant Annex to the Directive as set out in the relevant Schedule.”.

(4) Omit paragraph (2).

Insertion of regulation 2A

3. After regulation 2 insert—

“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, 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).

(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 technical specifications adopted by the other recognised standardisation bodies.

(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.”.

Amendment to regulation 3

4.—(1) In regulation 3 (meaning of “measuring instrument” and related expressions and application of these Regulations) in the heading—

(a)before “measuring” insert “regulated”;

(b)omit “and related expressions”; and

(2) omit paragraphs (1) and (3).

Amendment to regulation 7

5. In regulation 7 (manufacturers’ responsibilities - design, conformity assessment and marking of regulated measuring instruments)—

(a)in paragraph (d), for “an EU”, substitute “a”; and

(b)in paragraph (e)(i), for “CE”, substitute “UK”.

Amendment to regulation 8

6. In regulation 8 (manufacturers - obligations in respect of records) omit “EU”.

Amendment to regulation 9

7. In regulation 9 (manufacturers’ obligations to ensure continuing conformity with essential requirements), in paragraph (2)(b), for “harmonised”, substitute “designated”.

Amendment to regulation 11

8. In regulation 11 (manufacturers to mark contact details on regulated measuring instruments where possible), for paragraph (4) substitute—

“(4) The contact details required by this regulation must be clear, legible and in easily understandable English.”

Amendment to regulation 12

9. In regulation 12 (documentation to accompany regulated measuring instruments)—

(a)in paragraph (1)(a), omit “EU”;

(b)omit paragraph (3); and

(c)in paragraph (4), for “understandable and intelligible” substitute “legible and in easily understandable English”.

Amendment to regulation 13

10. In regulation 13 (action to be taken where regulated measuring instruments placed on the market are not in conformity with the essential requirements), in paragraph (3), for “national” to “market”, substitute “authority”.

Amendment to regulation 15

11. In regulation 15 (use of authorised representatives by manufacturers)—

(a)in paragraph (1) for “an” substitute “a person established in the United Kingdom as their”;

(b)in paragraph (3)(a), omit “EU”.

Amendment to regulation 16

12. In regulation 16 (introductory), omit “European Economic Area that is imported into the”.

Amendment to regulation 17

13. In regulation 17 (ensuring compliance of regulated measuring instruments), in paragraph (2)—

(a)in sub-paragraph (c), for “CE”, substitute “UK”; and

(b)in sub-paragraph (d), omit “EU”.

Amendment to regulation 19

14. In regulation 19 (requirements to mark importers’ details on regulated measuring instruments)—

(a)for paragraph (2) substitute—

“(2) Paragraph (1) does not apply where—

(a)either—

(i)the regulated measuring instrument it too small or too sensitive a composition to allow it to bear the information required by paragraph (1); or

(ii)the importer has imported the regulated measuring instrument from an EEA state and places it on the market within the period of 18 months beginning with exit day, and

(b)before placing the regulated measuring instrument on the market, the importer sets out the information referred to in paragraph (1)—

(i)where sub-paragraph (a)(i) applies, on any packaging in which the instrument is supplied and in any accompanying documents;

(ii)where sub-paragraph (a)(ii) applies, in a document accompanying the instrument.”;

(b)for paragraph (3) substitute—

“(3) Any contact details required by this regulation must be clear, legible and in easily understandable English.”.

Amendment to regulation 20

15. In regulation 20 (importers’ duty to ensure that regulated measuring instruments are accompanied by relevant documentation)—

(a)in paragraph (1), omit “in a language easily understood by end-users”; and

(b)for paragraph (2), substitute—

“(2) The instructions and information referred to in paragraph (1) must be clear, legible and in easily understandable English.”.

Amendment to regulation 24

16. In regulation 24 (requirement for importer to keep copy of EU declaration of conformity), and in the heading to that regulation, omit “EU”.

Amendment to regulation 28

17. In regulation 28 (distributors - verification obligations)—

(a)in paragraph (1), for “CE”, substitute “UK”;

(b)in paragraph (2)(a), omit “EU”; and

(c)for paragraph (4), substitute—

“(4) Instructions and information supplied in accordance with this regulation must be clear, legible and in easily understandable English.”.

Insertion of regulation 33A and 33B

18. After regulation 33 insert—

“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)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 “relevant 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.”.

Amendment to Part 3

19. Omit Part 3 (non-prescribed measuring instruments).

Amendment to regulation 36

20. For regulation 36 (introductory), substitute—

“36. This chapter applies for the purposes of establishing whether a regulated measuring instrument complies with the essential requirements.”.

Amendment to regulation 37

21. In regulation 37 (methods of establishing conformity with the essential requirements)—

(a)in the opening words insert “regulated” before “measuring”;

(b)in paragraph (a)—

(i)for “harmonised”, the first time it appears, substitute “designated”; and

(ii)omit from “where” to “Union”;

(c)in paragraph (b), for “in the Official Journal of the European Union”, substitute “by the Secretary of State”.

Amendment to regulation 38

22. In regulation 38 (presumptions of conformity of measuring instruments)—

(a)in paragraphs (1) and (2) and in the heading, before “measuring” insert “regulated”;

(b)in paragraphs (1) and (3), for “harmonised”, substitute “designated”.

Amendment to regulation 39

23. In regulation 39 (conformity assessment procedures)—

(a)in paragraph (1)—

(i)before “measuring” insert “regulated” in both places it occurs;

(ii)for “1” substitute “1C to 1J”; and

(b)in paragraph (2), for “A notified” substitute “An approved”.

Insert of regulation 39A

24. After regulation 39, insert—

“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.”.

Amendment to regulation 40

25. In regulation 40 (capacity serving measures – accredited in house bodies)—

(a)in paragraph (2) for “of Annex II to the Directive” substitute “in Schedule 1B”;

(b)in paragraphs (3) and (4)(c), before “measuring” insert “regulated”; and

(c)for paragraph (5) substitute—

(5) An accredited in-house body need not be approved by the Secretary of State, but information concerning its accreditation must be given by the undertaking of which it forms part to the Secretary of State at the request of the Secretary of State.

Amendment to regulation 41

26. For regulation 41 (subsidiaries and contractors) substitute—

“Subsidiaries and contractors

41.—(1) An approved body may subcontract specific conformity assessment activities, or use a subsidiary to carry out such activities provided—

(a)the body is satisfied that the subcontractor or subsidiary meets the approved body requirements;

(b)the body has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meets those requirements; and

(c)the economic operator for whom the activities are to be carried out has consented to the activities being carried out by that person.

(2) The approved body which subcontracts specific conformity assessment activities or uses a subsidiary to carry out such activities remains responsible for the proper performance of those activities (irrespective of where the subcontractor or subsidiary is established).

(3) Where an approved body subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the approved body must, for a period of 10 years beginning on the day on which the activity is first carried out, keep available for inspection by the Secretary of State all relevant documentation concerning—

(a)the assessment of the qualifications of the subcontractor or the subsidiary; and

(b)the conformity assessment activity carried out by the subcontractor or subsidiary.

(4) In this regulation “subsidiary” has the meaning given to it in section 1159 of the Companies Act 2006(2).”.

Amendment to regulation 42

27. In regulation 42 (fees)—

(a)for “a United Kingdom notified” substitute “an approved” in both places in which it occurs;

(b)in paragraph (2)(a) for “United Kingdom notified” substitute “approved”.

Amendment to regulation 44

28. In regulation 44 (general requirements to be met by technical documentation)—

(a)in paragraphs (1)(a), (2)(b) and (2)(c) before “measuring” insert “regulated”;

(b)in paragraph (1)(b) for “the Directive” substitute “these Regulations”.

Amendment to regulation 45

29. In regulation 45 (specific information to be included in technical documentation), in paragraph (1)—

(a)before “measuring” insert “regulated” in each place it occurs;

(b)in sub-paragraph (f)—

(i)for “harmonised”, substitute “designated”; and

(ii)omit “, the references of which have been published in the Official Journal of the European Union”;

(c)in sub-paragraph (g) for “harmonised” substitute “designated”;

(d)in sub-paragraph (i)(i) for “the Directive” substitute “these Regulations”;

(e)in sub-paragraph (i)(ii ) for “, water and thermal-energy” substitute “and water”;

(f)in sub-paragraph (j)—

(i)for “EU-type” substitute “type”;

(ii)omit “EU” in the second place it occurs.

Amendment to the heading of Chapter 3

30. In the heading to Chapter 3 omit “EU”.

Amendment to regulation 46

31. In regulation 46 (application of Chapter)—

(a)omit “EU”; and

(b)before “measuring” insert “regulated”.

Amendment to regulation 47

32. In regulation 47 (form and contents of EU declaration of conformity etc)—

(a)in paragraphs (1) and (2) and in the heading, omit “EU”;

(b)in paragraph (1)(b) for “Annex II to the Directive” substitute “Schedule 1B”; and

(c)in paragraph (1)(c) for “Annex XIII to the Directive” substitute “Schedule 1K”.

Amendment to regulation 48

33. For regulation 48 (measuring instruments that require more than one declaration of conformity) substitute—

“Regulated measuring instruments that require more than one declaration of conformity

48. Where a regulated measuring instrument is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.”.

Amendment to regulation 49

34. In regulation 49 (responsibility of manufacturer that draws up declaration of conformity)—

(a)for “an EU” substitute “a”; and

(b)before “measuring” insert “regulated” in both places it occurs.

Amendment to regulation 50

35. In regulation 50 (conformity with Directive requirements to be indicated by the CE marking)—

(a)in the heading omit “Directive”; and

(b)in the regulation and in the heading, for “CE”, substitute “UK”.

Amendment to regulation 51

36. For regulation 51 (general principles relating to the M marking), substitute—

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

51.—(1) An economic operator must not affix the UK marking or the M marking to a regulated measuring instrument unless—

(a)that economic operator is the manufacturer of the regulated measuring instrument; and

(b)the conformity of the regulated measuring instrument with the essential requirements has been demonstrated by a relevant conformity assessment procedure.

(2) An economic operator must not affix a marking to a regulated measuring instrument which is not the UK marking or the M marking but which purports to attest that the regulated measuring instrument satisfies the essential requirements.

(3) An economic operator must not affix to a regulated measuring instrument a marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the marking.

(4) An economic operator must not affix to a regulated measuring instrument any other marking if the visibility, legibility and meaning of the UK marking or the M marking would be impaired as a result.”.

Amendment to regulation 52

37. In regulation 52 (rules and conditions for affixing the CE marking and the M marking)—

(a)in paragraphs (1) to (6) before “measuring” insert “regulated” in each place it occurs;

(b)in paragraphs (1) and (7) and in the heading, for “CE”, substitute “UK”;

(c)in paragraph (4) omit “, not being sub-assemblies”;

(d)in paragraph (8) for “Annex II to the Directive” substitute “Schedule 1B”; and

(e)in paragraphs (8), (9) and (10) for “notified” substitute “approved”.

Amendment to Part 5

38. For Part 5 substitute—

“PART 5Approval of Conformity Assessment Bodies

Approved bodies

53.—(1) An approved body is a conformity assessment body which—

(a)has been approved by the Secretary of State pursuant to the procedure set out in regulation 54 (approval of conformity assessment bodies); or

(b)immediately before exit day was a notified body in respect of which the Secretary of State had taken no action under regulation 60(1) or (2) as they had effect immediately before exit day to suspend or withdraw the body’s status as a notified body.

(2) Paragraph (1) has effect subject to regulation 57 (restriction, suspension or withdrawal of approval).

(3) In this Part—

“notified body” means a body—

(a)

which the Secretary of State had before exit day notified to the European Commission and the member States of the European Union, in accordance with Article 23 of the Directive; and

(b)

in respect of which no objections had been raised, as referred to in regulation 53(2)(b), as it had effect immediately before exit day;

“approved body requirements” means the requirements set out in Schedule 5.

Approval of conformity assessment bodies

54.—(1) The Secretary of State may approve only those conformity assessment bodies that qualify for approval.

(2) A conformity assessment body qualifies for approval if the first and second conditions below are met.

(3) The first condition is that the conformity assessment body has applied to the Secretary of State to become an approved body and that application is accompanied by—

(a)a description of—

(i)the conformity assessment activities that the conformity assessment body intends to carry out;

(ii)the conformity assessment procedure in respect of which the conformity assessment body claims to be competent; and

(iii)the regulated measuring instrument for which the conformity assessment body claims to be competent; and

(b)either—

(i)an accreditation certificate; or

(ii)the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body’s compliance with the approved body requirements.

(4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements.

(5) For the purposes of paragraph (4), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (3)(b)(i), as sufficient evidence that the conformity assessment body meets the approved body requirements.

(6) When deciding whether to approve a conformity assessment body that qualifies for approval, the Secretary of State may–

(a)have regard to any other matter which appears to the Secretary of State to be relevant; and

(b)set conditions that the conformity assessment body must meet.

(7) For the purposes of this regulation “accreditation certificate” means a certificate, issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements.

Presumption of conformity of approved bodies

55.—(1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a designated standard (or part of such standard), the Secretary of State is to presume that the conformity assessment body meets the approved body requirements covered by that standard (or that part of that standard).

(2) The presumption in paragraph (1) is rebuttable.

Monitoring

56. The Secretary of State must monitor each approved body with a view to verifying that the body—

(a)continues to meet the approved body requirements;

(b)meets any conditions set—

(i)in accordance with regulation 54(6)(b); or

(ii)in the case of an approved body which was a notified body immediately before exit day, in accordance with regulation 54(6)(b) as it applied immediately before exit day; and

(c)carries out its functions in accordance with these Regulations.

Restriction, suspension or withdrawal of approval

57.—(1) Where the Secretary of State determines that an approved body—

(a)no longer meets an approved body requirement, or

(b)is failing to fulfil its obligations under these Regulations, other than a condition referred to in regulation 54(6)(b),

the Secretary of State must restrict, suspend or withdraw the body’s status as an approved body under regulation 54 (approval of conformity assessment bodies).

(2) With the consent of an approved body, or where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 56(b), the Secretary of State may restrict, suspend or withdraw the body’s status as an approved body under regulation 54 (approval of conformity assessment bodies).

(3) In deciding what action is required under paragraph (1) or (2), the Secretary of State must have regard to the seriousness of the non-compliance.

(4) Before taking action under paragraph (1) or (2), the Secretary of State must—

(a)give notice in writing to the approved body of the proposed action and the reasons for it;

(b)give the approved body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and

(c)consider any such representations made by the approved body.

(5) Where the Secretary of State has taken action in respect of an approved body under paragraph (1) or (2), or where an approved body has ceased its activity, the approved body must—

(a)on the request of the Secretary of State, transfer its files relating to the activities it has undertaken as an approved body to another approved body or to the Secretary of State; or

(b)in the absence of a request under sub-paragraph (a), ensure that its files relating to the activities it has undertaken as an approved body are kept available for the Secretary of State and competent authorities for a period of 10 years from the date they were created.

(6) The activities undertaken as an approved body referred to in paragraph (5) include any activities that the body has undertaken as a notified body.

(7) The Secretary of State may impose a monetary penalty on an approved body that fails to comply with any requirement imposed by or under paragraph (5).

(8) Schedule 7 has effect in relation to a monetary penalty imposed under paragraph (7).

Register of approved bodies

58.—(1) The Secretary of State must—

(a)assign an approved body identification number to each approved body; and

(b)compile and maintain a register of—

(i)approved bodies;

(ii)their approved body identification numbers;

(iii)the activities for which they have been approved; and

(iv)any restrictions on those activities.

(2) The register referred to in paragraph (1) must be made publicly available.

UK national accreditation body

59.—(1) The Secretary of State may authorise the UK national accreditation body to carry out the following activities on behalf of the Secretary of State—

(a)assessing whether a conformity assessment body meets the approved body requirements; and

(b)monitoring approved bodies in accordance with regulation 56;

(2) Where the Secretary of State authorises the UK national accreditation body pursuant to paragraph (1), the Secretary of State remains fully responsible for anything done pursuant to that authorisation.”.

Amendment to regulation 63

39. In regulation 63 (regulated measuring instruments presenting a risk)—

(a)in paragraph (5) for “notified”, substitute “approved”;

(b)omit paragraph (6);

(c)in paragraph (7) for “on the market throughout the European Economic Area”, substitute “in the United Kingdom”;

(d)in paragraph (9) for “Commission and the other EEA States”, substitute “Secretary of State”;

(e)in paragraph (10)(f)(ii) for “harmonised” substitute “designated”.

Amendment to regulation 64

40. Omit regulation 64 (EU safeguard procedure).

Amendment to regulation 65

41. In regulation 65 (compliant regulated measuring instruments which present a risk) omit paragraph (3).

Amendment to regulation 68

42. In regulation 68 (compliance notice procedure), in paragraph (1)—

(a)in sub-paragraphs (a) and (b) for “CE” substitute “UK” in each place in which it occurs;

(b)in sub-paragraph (a) for “Article 30 of the RAMS regulation or the requirements of these Regulations” substitute “regulation 51 or regulation 52”;

(c)in sub-paragraph (c) for “notified” substitute “approved” in each place in which it occurs; and

(d)in sub-paragraph (d) omit “EU”.

Amendment to regulation 69

43. In regulation 69 (enforcement notices)—

(a)in paragraph (5)—

(i)for “a United Kingdom notified” substitute “an approved”;

(ii)for “that notified” substitute “that approved”; and

(b)omit paragraph (6).

Amendment to regulation 72

44. In regulation 72 (disqualification)—

(a)in paragraph (2)—

(i)in sub-paragraph (a) for “CE”, substitute “UK”;

(ii)in sub-paragraph (c) for “notified”, substitute “approved”; and

(b)in paragraph 3(b) omit “EU-” in each place it occurs.

Amendment to regulation 73

45. In regulation 73 (requalification) in paragraph 3(b), omit “EU-” in each place it occurs.

Amendment to regulation 75

46. In regulation 75 (unauthorised application of authorised marks), paragraph (5)—

(a)in sub-paragraph (a) for “CE” substitute “UK”; and

(b)in sub-paragraph (c) for “notified” substitute “approved”.

Amendment to regulation 81

47. In regulation 81 (review) omit paragraph (2).

Amendment to Schedule 1

48. Omit Schedule 1 (essential requirements and applicable conformity assessment procedures).

Insertion of Schedules

49. Before Schedule 2 insert—

Regulation 2

“SCHEDULE 1AESSENTIAL 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.

The essential requirements that shall be met by regulated measuring instruments are set out below and are supplemented, where appropriate, by instrument-specific requirements in Schedules 1C to 1J that provide more detail on certain aspects of the general requirements.

The solutions adopted in the pursuit of the essential requirements shall take account of the intended use of the instrument and any foreseeable misuse thereof.

DEFINITIONS

Measurand	The measurand is the particular quantity subject to measurement
Influence quantity	An influence quantity is a quantity that is not the measurand but that affects the result of measurement.
Rated Operating Conditions	The rated operating conditions are the values for the measurand and influence quantities making up the normal working conditions of an instrument.
Disturbance	An influence quantity having a value within the limits specified in the appropriate requirement but outside the specified rated operating conditions of the regulated measuring instrument. An influence quantity is a disturbance if for that influence quantity the rated operating conditions are not specified.
Critical change value	The critical change value is the value at which the change in the measurement result is considered undesirable.
Material Measure	A material measure is a device intended to reproduce or supply in a permanent manner during its use one or more known values of a given quantity.
Direct sales	A trading transaction is direct sales if: the measurement result serves as the basis for the price to pay; and at least one of the parties involved in the transaction related to measurement is a consumer or any other party requiring a similar level of protection; and all the parties in the transaction accept the measurement result at that time and place.
Climatic environments	Climatic environments are the conditions in which regulated measuring instruments may be used. To cope with climatic differences, a range of temperature limits has been defined.
Utility	A utility is regarded as a supplier of electricity, gas or water.

ESSENTIAL REQUIREMENTS

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.

Unless stated otherwise in the instrument-specific Schedules, MPE is expressed as a bilateral value of the deviation from the true measurement value.

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

Where the instrument is intended to be used in a specified permanent continuous electromagnetic field the permitted performance during the radiated electromagnetic field-amplitude modulated test shall be within MPE.

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

1.3.1 Climatic environments

The manufacturer shall specify the upper temperature limit and the lower temperature limit from any of the values in Table 1 unless otherwise specified in Schedules 1C to 1J and indicate whether the instrument is designed for condensing or non-condensing humidity as well as the intended location for the instrument, i.e. open or closed.

Table 1

	Temperature Limits
Upper temperature limit	30 ^oC	40 ^oC	55 ^oC	70 ^oC
Lower temperature limit	5 ^oC	-10 ^oC	-25 ^oC	-40 ^oC

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

M1	This class applies to instruments used in locations with vibration and shocks of low significance, e.g. for instruments fastened to light supporting structures subject to negligible vibrations and shocks transmitted from local blasting or pile-driving activities, slamming doors, etc.
M2	This class applies to instruments used in locations with significant or high levels of vibration and shock, e.g. transmitted from machines and passing vehicles in the vicinity or adjacent to heavy machines, conveyor belts, etc.
M3	This class applies to instruments used in locations where the level of vibration and shock is high and very high, e.g. for instruments mounted directly on machines, conveyor belts, etc.

(b)The following influence quantities shall be considered in relation with mechanical environments:

vibration
mechanical shock

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

This class applies to instruments used in locations with electromagnetic disturbances corresponding to those likely to be found in residential, commercial and light industrial buildings.

This class applies to instruments used in locations with electromagnetic disturbances corresponding to those likely to be found in other industrial buildings.

This class applies to instruments supplied by the battery of a vehicle. Such instruments shall comply with the requirements of E2 and the following additional requirements:

voltage reductions caused by energising the starter-motor circuits of internal combustion engines,
load dump transients occurring in the event of a discharged battery being disconnected while the engine is running.

(b)The following influence quantities shall be considered in relation with electromagnetic environments:

voltage interruptions;
short voltage reductions;
voltage transients on supply lines and/or signal lines;
electrostatic discharges;
radio frequency electromagnetic fields;
conducted radio frequency electromagnetic fields on supply lines and/or signal lines;
surges on supply lines and/or signal lines.

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

voltage variation;
mains frequency variation;
power frequency magnetic fields;
any other quantity likely to influence in a significant way the accuracy of the instrument.

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

1.4.1 Basic rules for testing and the determination of errors

Essential requirements specified in paragraphs 1.1 and 1.2 shall be verified for each relevant influence quantity. Unless otherwise specified in the appropriate instrument-specific Schedule, these essential requirements apply when each influence quantity is applied and its effect evaluated separately, all other influence quantities being kept relatively constant at their reference value.

Metrological tests shall be carried out during or after the application of the influence quantity, whichever condition corresponds to the normal operational status of the instrument when that influence quantity is likely to occur.

1.4.2 Ambient humidity

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

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

2. Reproducibility

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

3. Repeatability

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

4. Discrimination and Sensitivity

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

5. Durability

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.

6. Reliability

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.

7. Suitability

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

7.2. 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.

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

7.4. 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.

7.5. 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.

7.6. 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.

When a regulated measuring instrument has associated software which provides other functions besides the measuring function, the software that is critical for the metrological characteristics shall be identifiable and shall not be inadmissibly influenced by the associated software.

8. Protection against corruption

8.1. 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.

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

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

Software identification shall be easily provided by the regulated measuring instrument.

Evidence of an intervention shall be available for a reasonable period of time.

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

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

9. Information to be borne by and to accompany the instrument

9.1. 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.

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

9.3. 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;

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

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

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

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

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

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

10. Indication of result

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

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

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

10.4. 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.

10.5. 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.

11. Further processing of data to conclude the trading transaction

11.1. 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.

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

12. Conformity evaluation

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

Regulations 2, 40(2),47(1)(b) and 52(8)

SCHEDULE 1BCONFORMITY 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.

2. Technical documentation

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.

3. Manufacturing

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

4. Instrument checks

At the choice of the manufacturer, either an accredited in-house body or 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.

In those cases where a relevant number of instruments in the sample do not conform to an acceptable quality level, the accredited in-house body or approved body shall take appropriate measures.

Where the tests are carried out by an approved body, the manufacturer shall, under the responsibility of the approved body, affix the approved body’s identification number during the manufacturing process.

5. Conformity marking and declaration of conformity

5.1. 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.

5.2. 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.

A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request.

A copy of the declaration of conformity shall be supplied with each regulated measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user.

6. Authorised representative

The manufacturer’s obligations set out in 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 BTYPE 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).

The approved body decides on the appropriate manner and the specimens required.

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

The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

(b)a written declaration that the same application has not been lodged with any other approved body;

(c)the technical documentation set out in regulations 44 and 45. The technical documentation shall make it possible to assess the instrument’s conformity with the applicable requirements of these Regulations and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument.

The application shall in addition contain, wherever applicable:

(d)the specimens, representative of the production envisaged. The approved body may request further specimens if needed for carrying out the test programme;

(e)the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant designated standards, and/or normative documents have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

4. The approved body shall:

For the instrument:

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

For the specimen(s):

4.2. verify that the specimen(s) have been manufactured in conformity with the technical documentation and identify the elements which have been designed in accordance with the applicable provisions of the relevant designated standards and/or normative documents, as well as the elements which have been designed in accordance with other relevant technical specifications;

4.3. carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant designated standards and normative documents, these have been applied correctly;

4.4. carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant 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;

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

For the other parts of the regulated measuring instrument:

4.6. 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.

The type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured regulated measuring instruments with the examined type to be evaluated and to allow for in-service control. In particular, to allow the conformity of manufactured instruments to be evaluated with the examined type regarding the reproducibility of their metrological performances, when they are properly adjusted using appropriate means, content shall include:

the metrological characteristics of the type of instrument;
measures required for ensuring the integrity of the instruments (sealing, identification of software, etc.);
information on other elements necessary for the identification of the instruments and to check their visual external conformity to type;
if appropriate, any specific information necessary to verify the characteristics of manufactured instruments.

The type examination certificate shall have a validity of 10 years from the date of its issue, and may be renewed for subsequent periods of 10 years each.

Where the type does not satisfy the applicable requirements of these Regulations, the approved body shall refuse to issue a type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

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.

The other approved bodies and the Secretary of State may, on request, obtain a copy of the type examination certificates and/or additions thereto. On request, the Secretary of State may obtain a copy of the technical documentation and the results of the examinations carried out by the approved body.

The approved body shall keep a copy of the type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the expiry of the validity of that certificate.

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.

2. Manufacturing

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.

3. Quality system

3.1. 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.

The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

(b)a written declaration that the same application has not been lodged with any other approved body,

(c)all relevant information for the instrument category envisaged;

(d)the documentation concerning the quality system;

(e)the technical documentation of the approved type and a copy of the type examination certificate.

3.2. 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.

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;

(b)the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

(c)the examinations and tests that will be carried out before, during, and after manufacture, and the frequency with which they will be carried out;

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

(e)the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

3.3. 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.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of these Regulations. The audit shall include an assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to in paragraph 3.1(e), to verify the manufacturer’s ability to identify the relevant requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

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

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

The approved body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the approved body

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

4.2. The manufacturer shall, for assessment purposes, allow the 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.

4.3. 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.

4.4. 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.

5. Conformity marking and declaration of conformity

5.1. 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.

5.2. 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.

A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request.

6. The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the 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;

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

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.

8. Authorised representative

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.

2. Technical documentation

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.

4. Manufacturing

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.

5. Quality system

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

The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

(b)a written declaration that the same application has not been lodged with any other approved body;

(c)all relevant information for the instrument category envisaged;

(d)the documentation concerning the quality system;

(e)the technical documentation referred to in paragraph 2.

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

It shall, in particular, contain an adequate description of:

(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;

(b)the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

(c)the examinations and tests that will be carried out before, during, and after manufacture, and the frequency with which they will be carried out;

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

(e)the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

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

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard.

The auditing team shall review the technical documentation referred to in paragraph 2 in order to verify the manufacturer’s ability to identify the relevant requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

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

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

The approved body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 5.2 or whether a re-assessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

6. Surveillance under the responsibility of the approved body

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

6.2. The manufacturer shall, for assessment purposes, allow the 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 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.

6.3. 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.

6.4. 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.

7. Conformity marking and declaration of conformity

7.1. 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.

7.2. 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.

A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request.

8. The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the 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;

(c)the decisions and reports of the approved body referred to in paragraphs 5.5, 6.3 and 6.4.

9. 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.

10. Authorised representative

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.

2. Manufacturing

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.

3. Quality system

3.1. 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.

The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

(b)a written declaration that the same application has not been lodged with any other approved body;

(c)all relevant information for the instrument category envisaged;

(d)the documentation concerning the quality system;

(e)the technical documentation of the approved type and a copy of the type examination certificate.

3.2. 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.

It shall, in particular, contain an adequate description of:

(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;

(b)the examinations and tests that will be carried out after manufacture;

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

(d)the means of monitoring the effective operation of the quality system.

3.3. 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.

The auditing team shall review the technical documentation referred to in paragraph 3.1(e), in order to verify the manufacturer’s ability to identify the relevant requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of audit and the reasoned assessment decision.

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

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

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the approved body

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

(a)the quality system documentation;

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

4.3. 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. Conformity marking and declaration of conformity

5.1. 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.

A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request.

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

(a)the documentation referred to in paragraph 3.1;

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

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

8. Authorised representative

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.

2. Technical documentation

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.

4. Manufacturing

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.

5. Quality system

5.1. 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.

The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

(b)a written declaration that the same application has not been lodged with any other approved body;

(c)all relevant information for the instrument category envisaged;

(d)the documentation concerning the quality system;

(e)the technical documentation referred to in paragraph 2.

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

All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.