Regulation 33B Conformity assessment procedure obligation which is met by complying with the DirectiveF1
England, Wales and Scotland
In this regulation—
any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive;
“Module B” means the conformity assessment procedure set out under the heading “MODULE B: EU-TYPE EXAMINATION” in Annex II;
“EU-type examination certificate” means an EU-type examination certificate issued in accordance with Module B;
“harmonised standard” has the meaning given to it in Article 4(14);
“instrument-specific Annexes” means Annexes III to XII.
Paragraph (3) applies where—
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
before placing a regulated measuring instrument on the market, the manufacturer ensures that—
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
Module B has been complied with in respect of that regulated measuring instrument.
Where this paragraph applies—
any reference in regulation 7(c) to “relevant conformity assessment procedure” includes Module 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
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)