Paragraph 26 F1

In Annex III—

(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”;

(F2e)

omit Section 5;

(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”.

Annotations

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)
F2: Sch. 2A para. 26(e) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(12) (with reg. 6)