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18.—(1) The Measuring Instruments Regulations 2016(1) are amended as follows.
(2) In regulation 2(1), in the definition of “the Directive” omit the words from “and references to” to the end.
(3) In regulation 33A(8)(e) omit “relevant” in the first place in which it occurs.
(4) For regulation 33C substitute—
33C.—(1) In this regulation—
(a)any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive;
(b)“harmonised standard” has the meaning given to it in Article 4(14);
(c)“instrument-specific Annexes” means Annexes III to XII.
(2) Paragraph (3) applies where, before placing a regulated measuring instrument on the market, the manufacturer—
(a)ensures that the regulated measuring instrument has been designed and manufactured in accordance with the essential requirements set out in Annex I and in the relevant instrument-specific Annex which applies to the regulated measuring instrument;
(b)ensures that one of the relevant conformity assessment procedures listed in the relevant instrument-specific Annex that apply to that regulated instrument in accordance with Article 17 has been carried out;
(c)draws up the technical documentation referred to in Article 18; and
(d)ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English.
(3) Where this paragraph applies—
(a)the requirements of regulations 7(1)(a) to (c), 44 and 45 are to be treated as being satisfied;
(b)except for regulations 47 to 52(1) to (7), Part 4 does not apply;
(c)regulations 8, 9, 15, 17(2)(a) and (b), 18, 21, 24, 29, 30, 51, 63, 68 and 76 apply subject to the modifications in paragraph (4);
(d)regulation 47 and Schedule 1K apply subject to the modifications in paragraphs (4) and (5);
(e)regulations 48, 52, 72 and 73 apply subject to the modifications in paragraph (5).
(4) The modifications referred to in paragraph (3)(c) and (d) are that—
(a)any reference to “essential requirements” is to be read as a reference to the essential requirements referred to in Annex I and in the relevant instrument-specific Annex which applies to the regulated measuring instrument;
(b)any reference to “designated standard” is to be read as a reference to a harmonised standard;
(c)any reference to “conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedure that applies to the regulated measuring instrument in accordance with Article 17;
(d)any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Article 18.
(5) The modifications referred to in paragraph (3)(d) and (e) are that—
(a)in regulations 47(1)(b) and 52 any reference to “Schedule 1B” is to be read as a reference to Annex II;
(b)in regulation 48 any reference to “enactment” is to be read as including the Directive;
(c)regulation 52(10) is to be read as if the words beginning with “and” and ending with “body” were omitted;
(d)in regulations 72(3)(b) and 73(3)(b)—
(i)any reference to “type examination certificate” is to be read as a reference to an EU-type examination certificate issued under the conformity assessment procedure set out under the heading “MODULE B: EU TYPE EXAMINATION” in Annex II;
(ii)any reference to “design examination certificate” is to be read as a reference to an EU-design examination certificate issued in accordance with the conformity assessment procedure set out under the heading “MODULE H1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION” in Annex II.
(e)in Schedule 1K—
(i)in paragraph 5 the reference to “relevant statutory requirements” is to be read as including the Directive;
(ii)in paragraph 7 the reference to “approved body” is to be read as a reference to any conformity assessment body that undertook a conformity assessment procedure in respect of the regulated measuring instrument in accordance with Article 17.”.
(5) In Schedule 3, in paragraph 2A—
(a)omit sub-paragraphs (4), (8) and (9);
(b)in sub-paragraph (7)(c) for “13” substitute “17”.
S.I. 2016/1153; they were made in part under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393; there are other amending instruments but none is relevant.
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