30.—(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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F7(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F1Words 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)
F2Words 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)
F3Words 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)
F4Words 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)
F5Words 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)
F6Reg. 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))
F7Reg. 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)
30.—(1) A manufacturer of a relevant device or, where applicable, his authorised representative who is required to follow, or follows or has followed a conformity assessment procedure set out in Directive 90/385 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, his authorised representative shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with Directive 90/385 at an intermediate stage of manufacture of the device.
[F8(3) Except as provided in paragraphs (4) and (5), the manufacturer of a relevant device, who under their own name places devices on the market, in accordance with the procedure referred to in Article 9(2) of Directive 90/385, shall provide the Secretary of State with—
(a)the address of their registered place of business;
(b)a description of the devices concerned; and
(c)details of the label and instructions for use that accompany each device.
(4) Where the manufacturer of a relevant device places a device on the market under their own name, but does not have a registered place of business in [F9a relevant state], the manufacturer shall—
(a)designate a single authorised representative; and
(b)ensure that the authorised representative has a registered place of business in [F9a relevant state].
(5) The authorised representative referred to in paragraph (4) shall provide the competent authority of [F10the relevant state] in which they have their registered place of business with the information referred to in paragraph (3) above.]
Extent Information
E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F8Reg. 30(3)-(5) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 14
F9Words in reg. 30(4) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 11(a)
F10Words in reg. 30(5) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 11(b)