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Regulation 33B Conformity assessment procedure obligation which is met by complying with the DirectiveF1

England, Wales and Scotland

(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.

Annotations

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)