Paragraph 19 F1

In Annex VIII—

(a)

in Section 1, for “authorized representative” substitute “UK responsible person”;

(b)

in Section 2.2 in the seventh indent for “Directive 2003/32/EC” substitute “Regulation 722/2012”;

(c)

in Section 3, for “competent national authorities” substitute “Secretary of State”;

(d)

in Sections 3.1 and 3.2, for “this Directive” each time it occurs substitute “the Regulations”;

(e)

in Section 3.2—

(i)

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

(ii)

in the sixth indent, for “Directive 2003/32/EC” substitute “Regulation 722/2012”;

(F2f)

omit Section 5.

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. 19(f) 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(11) (with reg. 6)