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) [F4The manufacturer of a relevant device, who places devices on the market, in accordance with the procedure referred to in Article 9(2) of Directive 90/385, or, if not the manufacturer, the person placing custom-made devices on the market under that Article, must 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.
F5(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F5(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)-(5) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 14
F4Words in reg. 30(3) 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)(b) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 32); 2020 c. 1, Sch. 5 para. 1(1)
F5Reg. 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)