[F1 SCHEDULE 2A E+W+SModification of Annexes to Directives 90/385, 93/42, 98/79

Textual Amendments

F1 Sch. 2A inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 12 (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 56, 57); 2020 c. 1, Sch. 5 para. 1(1)

PART 3 E+W+SModification of Annexes to Directive 98/79

26.   In Annex III— E+W+S

(a) in the title and in Section 1, omit “EC”;

(b) in Section 1—

(i) for “authorised representative” substitute “UK responsible person”;

(ii) for “this Directive” substitute “the Regulations”;

(iii) for “CE marking in accordance with Article 16” substitute “UK marking in accordance with regulation 36 of the Regulations”;

(c) in Section 3, for “the Directive” in both places substitute “the Regulations”;

(d) in Section 3, in the sixth indent, for “Article 5” in both places substitute “regulation 3A of the Regulations”;

(e) in Section 5, for “competent authorities” substitute “Secretary of State”;

(f) in Section 6, for “a notified body” substitute “an approved body”;

(g) in Section 6.2—

(i) for “notified body”, both times those words occur, substitute “approved body”;

(ii) in the first sentence, for “this Directive” substitute “the Regulations”;

(iii) in the second sentence omit “of the Directive”;

(iv) for “an EC” substitute “a” ;

(h) in Section 6.3—

(i) for “notified body” in both places substitute “approved body”;

(ii) omit each reference to “EC”;

(iii) for “the Directive” substitute “the Regulations”.]