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

Insertion of regulations 39A and 39B

25.  After regulation 39 (prohibition on improper use of CE marking), insert—

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

39A.— (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(31); and

(c) “pressure equipment and assemblies” means the pressure equipment and assemblies referred to in Article 4(1) and (2).

(2) Paragraph (3) applies where, before placing pressure equipment or an assembly on the market, the manufacturer—

(a) ensures that the pressure equipment or assembly has been manufactured in accordance with the essential safety requirements set out in Annex I;

(b) ensures that the relevant conformity assessment procedures referred to in Article 14 have been carried out;

(c) draws up the technical documentation referred to in Annex III;

(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 identification number of the notified body (where that body is involved in the product control phase) in accordance with Articles 18 and 19(1) to (4);

(f) draws up an EU declaration of conformity, in accordance with Article 17; 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 9(1), 10 and 11(1) are to be treated as being satisfied;

(b) regulations 2(2)(a), 11(3), 12, 15(2), 19(2) and 39 apply subject to the modifications in paragraph (8); and

(c) Part 3 does not apply;

(d) regulation 74 does not apply.

(4) Paragraph (5) applies where, before placing pressure equipment or an assembly 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 pressure equipment or assembly bears the CE marking and any notified body identification number.

(5) Where this paragraph applies—

(a) the requirements of regulation 21(1)(a) to (c) 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 (8).

(6) Paragraph (7) applies where, before making pressure equipment or an assembly available on the market, a distributor ensures that the pressure equipment or assembly bears the CE marking.

(7) Where this paragraph applies—

(a) regulation 31(1)(a)(i) is to be treated as being satisfied; and

(b) regulations 2(2)(a) and 33(1) apply subject to the modifications in paragraph (8).

(8) The modifications referred to in sub-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) any reference to “essential safety requirements” is to be read as a reference to the essential safety requirements referred to in Annex I;

(d) any reference to “designated standard” is to be read as a reference to a harmonised standard within the meaning of Article 2(24); and

(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.

Conformity assessment procedure obligation which is met by complying with the Directive.

38B.— (1) In this regulation any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive.

(2) Paragraph (3) applies where, prior to the manufacture of pressure equipment or an assembly, the manufacturer ensures that the conformity assessment procedure that applies to that pressure equipment or assembly in accordance with Article 14(2), referred to as Module B and set out in Annex III, has been carried out.

(3) Where this paragraph applies—

(a) the requirement in regulation 42 to follow the conformity assessment procedure referred to in that regulation as Module B is to be treated as being satisfied;

(b) any reference to “relevant conformity assessment procedure” in regulations 10(1)(c), 11(1), 21(1)(a), 39(1)(b) and 48(b) is to be read as including the conformity assessment procedure referred to in Article 14(2), referred to as Module B and set out in Annex III; and

(c) any reference to “technical documentation” in regulations 10(1)(d), 21(1)(b) and 28(b) is to be read as including the technical documentation relating to the design of the pressure equipment or assembly referred to as Module B as set out in Annex III.”.