Manufacturers etc. and conformity assessment procedures for active implantable medical devicesE+W+S
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 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, [F2their UK responsible person] 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.
F3(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F4(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F4(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(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)
F3Reg. 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))
F4Reg. 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)
Manufacturers etc. and conformity assessment procedures for active implantable medical devicesN.I.
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.
[F5(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 [F6a 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 [F6a relevant state].
(5) The authorised representative referred to in paragraph (4) shall provide the competent authority of [F7the 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
F5Reg. 30(3)-(5) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 14
F6Words 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)
F7Words 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)