PART 2U.K.Obligations of economic operators

Authorised representativesU.K.

[F1Obligations which are met by complying with obligations in the DirectiveE+W+S

38A.—(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 3(25);

(c)“harmonised standard” has the meaning given to it in Article 3(17).

(2) Paragraph (3) applies where, before placing apparatus on the market, the manufacturer—

(a)ensures that the apparatus has been designed and manufactured in accordance with the essential requirements set out in Annex I;

(b)draws up the technical documentation relating to such apparatus referred to in Annex III;

(c)ensures that the relevant conformity assessment procedure relating to such apparatus referred to in Article 14 has been carried out;

(d)ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedure are prepared in or translated into English;

(e)affixes a CE marking, in accordance with Articles 16 and 17(1) to (2);

(f)draws up an EU declaration of conformity, in accordance with Article 15; 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 8, 9, 10(1)(a) and (b) and (3) and 42(1) are to be treated as being satisfied;

(b)regulations 2(2)(a), 10(2), 11, 12, 38(2) and 35 apply subject to the modifications in paragraph (8);

(c)[F2Part 3] does not apply; and

(d)regulation 59 does not apply.

(4) Paragraph (5) applies where, before placing a category apparatus on the market, the importer ensures that—

(a)the relevant conformity assessment procedure referred to in Article 14 has been carried out;

(b)the manufacturer has drawn up the technical documentation referred to in Annex III; and

(c)the apparatus bears the CE marking.

(5) Where this paragraph applies—

(a)the requirements of regulation 18(a) to (c) are to be treated as being satisfied; and

(b)regulations 2(2)(a), 17, 19(1), 22 and 24 apply subject to the modifications in paragraph (8).

(6) Paragraph (7) applies where, before making apparatus available on the market, a distributor ensures that the apparatus bears the CE marking.

(7) Where this paragraph applies—

(a)regulation 27(1)(a) is to be treated as being satisfied; and

(b)regulations 2(2)(a), 28(1) and 29 apply subject to the modifications in paragraph (10).

(8) The modifications referred to in sub-paragraphs (3)(b), (5)(b) and (9)(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)any reference to “essential requirements” is to be read as a reference to the essential F3... requirements referred to in Annex I;

(d)any reference to “designated standard” is to be read as a reference to a harmonised standard;

(e)any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedures referred to in Article 14;

(f)any reference to “technical documentation” is a reference to the technical documentation referred to in Annex III.]

Textual Amendments