Regulation 38B Further use of the UK markingF1F2
England, Wales and Scotland
In this regulation—
any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive;
“harmonised standard” has the meaning given to it in Article 3(17).
Paragraph (3) applies where, before placing apparatus on the market, the manufacturer—
ensures that the apparatus has been designed and manufactured in accordance with the essential requirements set out in Annex I;
draws up the technical documentation relating to such apparatus referred to in Annex III;
ensures that the relevant conformity assessment procedure relating to such apparatus referred to in Article 14 has been carried out; and
ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedure are prepared in or translated into English.
Where this paragraph applies—
the requirements of regulations 8 and 9 are to be treated as being satisfied;
except for regulations 41 and 42, Part 3 does not apply;
regulations 2(2)(a), 7, 11, 12, 17 to 19, 22, 24, 28, 29, 35(1), 41 and 59 apply subject to the modifications in paragraph (4);
regulation 10 and Schedule 4 apply subject to the modifications in paragraphs (4) and (5);
regulations 36 and 37 apply subject to the modifications in paragraph (6).
The modifications referred to in paragraph (3)(c) and (d) are that—
any reference to “essential requirements” is to be read as a reference to the essential requirements set out in Annex 1;
any reference to “designated standard” is to be read as a reference to “harmonised standard”;
any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedure referred to in Article 14;
any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Annex III.
The modifications referred to in paragraph (3)(d) are that—
in regulation 10, the reference to “enactment” is to be read as including the Directive;
in Schedule 4—
in paragraph 5, the reference to “statutory requirements” is to be read as including the Directive;
in paragraph 7, the reference to “approved body” is to be read as a reference to the conformity assessment body that undertook any conformity assessment procedure in accordance with Article 14.
The modifications referred to in paragraph (3)(e) are that—
in regulation 36 any reference to “paragraph 1 of Schedule 1” is to be read as a reference to paragraph 1 of Annex I;
in regulation 37 any reference to “paragraph 2 of Schedule 1” is to be read as a reference to paragraph 2 of Annex I.
Annotations
Textual amendments
- F1
Regs. 38A-38C inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 20 para. 24 (with Sch. 20 para. 33) (as amended by S.I. 2020/676, regs. 1(1), 2 and S.I. 2020/1460, reg. 1(4), Sch. 3 para. 12(3)); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Reg. 38B substituted (1.10.2024) by The Product Safety and Metrology etc. (Amendment) Regulations 2024 (S.I. 2024/696), regs. 1(2), 11(4) (with reg. 23)