Paragraph 18 F1

In Annex VII—

(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”;

(c)

in Section 2 for—

(i)

“his authorised representative” substitute “the manufacturer’s UK responsible person”;

(ii)

“national authorities” substitute “Secretary of State”;

(d)

in Section 3—

(i)

in the opening paragraph for “the Directive” substitute “the Regulations”;

(ii)

in the fourth indent—

(aa)

for “Article 5” in both places it occurs substitute “regulation 3A of the Regulations”;

(bb)

for “of the Directive” substitute “in Annex I”;

(F2e)

omit Section 4;

(f)

in Section 5, for “the intervention by the notified body” substitute “the intervention by the approved body”;

(g)

in Section 6, in the opening paragraph, for “Article 11(2)” substitute “regulation 13(2) of 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. 18(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(10) (with reg. 6)