The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019

New regulation 36A

27.  After regulation 36 insert—

“Obligations which are met by complying with obligations in the Directive

36A.— (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 2(26);

(c) “harmonised standard” has the meaning given to it in Article 2(18).

(2) Subject to paragraphs (6) and (7), paragraph (3) applies where, before placing radio equipment on the market, the manufacturer—

(a) ensures that the radio equipment has been designed and manufactured in accordance with the essential safety requirements set out in Article 3;

(b) ensures that the conformity assessment procedure that applies to that radio equipment in accordance with Article 17 of the Directive has been carried out;

(c) affixes a CE marking and where the conformity assessment procedure set out in Annex IV is applied, the notified body identification number, in accordance with Articles 19 and 20(1) to (3);

(d) draws up the technical documentation in accordance with Article 21;

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

(d) draws up an EU declaration of conformity, in accordance with Article 18; and

(e) 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, 9, 10(1) and (3) are to be treated as being satisfied;

(b) regulations 2(2)(a), 10(2), 11, 19(3) and 39 apply subject to the modifications in paragraph (8);

(c) Part 3 does not apply; and

(d) regulation 63 does not apply.

(4) Subject to paragraphs (6) and (7) paragraph (5) applies where, before placing radio equipment on the market, the importer ensures that—

(a) the conformity assessment procedure that applies to that radio equipment in accordance with Article 17 has been carried out;

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

(c) the radio equipment bears the CE marking referred to Article 19.

(5) Where this paragraph applies—

(a) the requirements of regulation 21(a) to (d) are to be treated as being satisfied; and

(b) regulations 2(2)(a), 22(1), 25 and 28 apply subject to the modifications in paragraph (10).

(6) This paragraph applies where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard as referred to in Article 16.

(7) Where paragraph (6) applies paragraphs (2)(b) and (4)(a) are to be treated as requiring the manufacturer to have carried out—

(a) one of the conformity assessment procedures in Article 17(1) with respect to the essential requirements set out in Article 3(1); and

(b) the conformity assessment procedure in Article 17(4) with respect to the essential requirements set out in Article 3(2) and (3).

(8) Paragraph (9) applies where, before making radio equipment available on the market, a distributor ensures that the radio equipment bears the CE marking referred to in Article 19.

(9) Where this paragraph applies—

(a) regulation 31(a)(i) is satisfied; and

(b) regulations 32(1) and 33 apply subject to the modifications in paragraph (10).

(10) The modifications referred to in sub-paragraphs (3)(b), (5)(b) and (8)(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 safety requirements” is to be read as a reference to the essential safety requirements set out in Article 3;

(d) any reference to “designated standard” is to be read as a reference to a harmonised standard within the meaning of Article 2(18);

(e) any reference to “relevant conformity assessment procedure” is to be read as a reference to the conformity assessment procedure that applies to the radio equipment in accordance with Article 17;

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