The Medical Devices Regulations 2002 No. 618

[F1 SCHEDULE 2A E+W+S Modification 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 1 E+W+S Modification of Annexes to Directive 90/385

[F2 8.   In Annex 7— E+W+S

(a) in Section 1.1 for “harmonised” substitute “designated”;

(b) in Section 2.3.5 for “all competent authorities of the Member States in which the clinical investigation is being performed” substitute “the Secretary of State”;]]

Textual Amendments

F2 Sch. 2A para. 8 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(d)