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The Medical Devices Regulations 2002, Section 17 is up to date with all changes known to be in force on or before 26 August 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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17.—(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 [F2this Part] 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, [F1their 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 [F2this Part] 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. 17 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(8)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 21); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in reg. 17 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(8)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 21); 2020 c. 1, Sch. 5 para. 1(1)
F3Reg. 17(3) omitted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(8)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 21); 2020 c. 1, Sch. 5 para. 1(1)
F4Reg. 17(4)(5) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 7
17.—(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 93/42 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 93/42 at an intermediate stage of manufacture of the device.
F5(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F6(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F6(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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. 17(3) omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 5
F6Reg. 17(4)(5) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 7
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