reg 33B Conformity assessment procedure obligation which is met by complying with the Directive
(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.