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Regulation 27 Procedures for affixing a UK marking to active implantable medical devicesF7E1

England, Wales and Scotland

A relevant device may bear a F1UK marking only if its manufacturer or F2their UK responsible person—

(a)

fulfils the applicable obligations imposed by—

(i)

Annex 2, or

(ii)

Annex 3, together with Annex 4 or 5;

(b)

declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of F3this Part that apply to it; F4...

(c)

ensures that the device meets the provisions of this Part which apply to it; F5and

F6(d)

fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).

Annotations

Textual amendments

F1

Words in reg. 27 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(5A)(b)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 29); 2020 c. 1, Sch. 5 para. 1(1)

F2

Words in reg. 27 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(5A)(b)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 29); 2020 c. 1, Sch. 5 para. 1(1)

F3

Words in reg. 27(b)(c) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(5A)(c) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 29); 2020 c. 1, Sch. 5 para. 1(1)

F4

Word in reg. 27(b) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 11(a)

F5

Word in reg. 27(c) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 11(b)

F6

Reg. 27(d) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 11(c)

F7

Words in reg. 27 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(5A)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 29); 2020 c. 1, Sch. 5 para. 1(1)

Extent

E1

This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only