reg 33A Obligations which are met by complying with obligations in 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) “ 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) 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 “ ... 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.