Regulation 30 Manufacturers etc. and conformity assessment procedures for active implantable medical devicesE1

England, Wales and Scotland

(1)

A manufacturer of a relevant device or, where applicable, F1their UK responsible person who is required to follow, or follows or has followed a conformity assessment procedure F2in the Annexes referred to in regulation 27(a) shall observe the manufacturer’s obligations set out in that procedure that apply to him.

(2)

A manufacturer of a relevant device or, where applicable, F3their UK responsible person shall, when following a conformity assessment procedure F4in the Annexes referred to in regulation 27(a), take account of the results of any assessment or verification operations which have been carried out F5... at an intermediate stage of manufacture of the device.

F6(3)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F7(4)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations

Textual amendments

F1: Words in reg. 30(1) 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(6)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 32); 2020 c. 1, Sch. 5 para. 1(1)
F2: Words in reg. 30(1) substituted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 14(a)
F3: Words in reg. 30(2) 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(6)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 32); 2020 c. 1, Sch. 5 para. 1(1)
F4: Words in reg. 30(2) inserted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 14(b)(i)
F5: Words in reg. 30(2) omitted (E.W.S.) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 14(b)(ii)
F6: Reg. 30(3) revoked (E.W.S.) (30.4.2021) by S.I. 2002/618, reg. 4D(6) (as inserted (E.W.S.) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1))
F7: Reg. 30(4)(5) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(6)(c) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 32); 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