The Measuring Instruments Regulations 2016

CHAPTER 4 U.K. IDENTIFICATION OF ECONOMIC OPERATORS

33.—(1) Economic operators must, on request, identify to the market surveillance authorities—

(a) any economic operator who has supplied them with a regulated measuring instrument; and

(b) any economic operator to whom they have supplied a regulated measuring instrument.

(2) Economic operators must be able to present the information referred to in paragraph (1) for 10 years beginning with the day after the day on which they have been supplied with the regulated measuring instrument and for 10 years day beginning with the day after the day they have supplied the instrument.

(3) The Secretary of State may impose a monetary penalty on an economic operator who fails to comply with an obligation imposed on it under this regulation.

(4) Schedule 7 has effect in relation to a monetary penalty imposed under paragraph (3).

[F1 Obligations which are met by complying with obligations in the Directive E+W+S

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) [F2 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 “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.

Textual Amendments

F1 Regs. 33A-33D inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 27 para. 18 (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2 and The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 (S.I. 2020/1460), reg. 1(4), Sch. 3 para. 19(4)(b)); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in reg. 33A(8)(c) inserted (E.W.S) (9.12.2021) by The Product Safety and Metrology etc. (Amendment) Regulations 2021 (S.I. 2021/1273), regs. 1, 12(2)

Conformity assessment procedure obligation which is met by complying with the Directive E+W+S

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.

Textual Amendments

F1 Regs. 33A-33D inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 27 para. 18 (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2 and The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 (S.I. 2020/1460), reg. 1(4), Sch. 3 para. 19(4)(b)); 2020 c. 1, Sch. 5 para. 1(1)

Expiry of regulations 33A and 33B E+W+S

33C.— (1) Subject to [F3 paragraphs (2) and (6)], regulation 33A ceases to have effect at the end of the period of [F4 four years] beginning with IP completion day.

(2) Notwithstanding the expiry of regulation 33A—

(a) any regulated measuring instrument which was placed on the market pursuant to regulation 33A may continue to be made available on the market on or after the expiry of regulation 33A;

(b) any obligation to which a person was subject under regulation 33A in respect of any regulated measuring instrument placed on the market pursuant to regulation 33A continues to have effect after the expiry of regulation 33A, in respect of that instrument.

(3) Subject to [F5 paragraphs (4) and (6)], regulation 33B ceases to have effect at the end of the period of [F6 four years] beginning with IP completion day.

(4) Where a conformity assessment procedure has been completed pursuant to regulation 33B in relation to a regulated measuring instrument prior to the expiry of regulation 33B, regulation 33B continues to apply in respect of that instrument where—

(a) the manufacturer arranges for the EU-Type examination certificate and any annexes to be transferred to an approved body;

(b) the approved body referred to in sub-paragraph (a) accepts responsibility for the EU-Type examination certificate; and

(c) the approved body issues a Type-examination certificate relying, or relying in part, on any examinations or tests undertaken prior to the issue of the EU-Type examination certificate.

(5) In paragraph (4) “EU-Type examination certificate” has the meaning given to it in regulation 33B(1)(c).

[F7 (6) Regulations 72 and 73 continue to have effect in relation to any regulated measuring instrument—

(a) placed on the market pursuant to 33A; or

(b) in relation to which a manufacturer has undertaken a conformity assessment procedure in accordance with regulation 33B,

as if regulations 32A or 33B had not expired.]

Textual Amendments

F1 Regs. 33A-33D inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 27 para. 18 (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2 and The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 (S.I. 2020/1460), reg. 1(4), Sch. 3 para. 19(4)(b)); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in reg. 33C(1) substituted (E.W.S) (9.12.2021) by The Product Safety and Metrology etc. (Amendment) Regulations 2021 (S.I. 2021/1273), regs. 1, 12(3)(a)

F4 Words in reg. 33C(1) substituted (E.W.S.) (31.12.2022) by The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (S.I. 2022/1393), regs. 1(1), 2, Sch. 1 para. (q)

F5 Words in reg. 33C(3) substituted (E.W.S) (9.12.2021) by The Product Safety and Metrology etc. (Amendment) Regulations 2021 (S.I. 2021/1273), regs. 1, 12(3)(b)

F6 Words in reg. 33C(3) substituted (E.W.S.) (31.12.2022) by The Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022 (S.I. 2022/1393), regs. 1(1), 2, Sch. 1 para. (q)

F7 Reg. 33C(6) inserted (E.W.S) (9.12.2021) by The Product Safety and Metrology etc. (Amendment) Regulations 2021 (S.I. 2021/1273), regs. 1, 12(3)(c)

Qualifying Northern Ireland Goods E+W+S

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.

[F8 (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.]

Textual Amendments

F1 Regs. 33A-33D inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 27 para. 18 (with Sch. 27 para. 50(a)) (as amended by S.I. 2020/676, regs. 1(1), 2 and The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 (S.I. 2020/1460), reg. 1(4), Sch. 3 para. 19(4)(b)); 2020 c. 1, Sch. 5 para. 1(1)

F8 Reg. 33D(3A) inserted (E.W.S) (9.12.2021) by The Product Safety and Metrology etc. (Amendment) Regulations 2021 (S.I. 2021/1273), regs. 1, 12(4)