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The Medical Devices Regulations 2002
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Rhagor o Adnoddau
Changes over time for: Section 17
Version Superseded: 01/04/2004
Alternative versions:
- 13/06/2002- Amendment
- 01/04/2004- Amendment
- 01/04/2009
Point in time - 21/10/2013- Amendment
- 31/12/2020- Amendment
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Point in time view as at 01/04/2009. This version of this provision has been superseded.
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Manufacturers etc. and conformity assessment procedures for general medical devicesU.K.
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.
(3) Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep available the technical documentation referred to in—
(a)Section 6.3 of Annex II or Section 7.4 of Annex III shall fall upon the person responsible for placing on the market the device to which the documentation relates or, where appropriate, upon the importer referred to in Section 13.3(a) of Annex I;
(b)Section 2 of Annex VII shall fall upon the person who places on the market the device to which the documentation relates.
[F1(4) Subject to paragraph (5), where a relevant device is manufactured utilising either animal tissue which is rendered non-viable or non-viable products derived from animal tissue, the manufacturer of that device or, where applicable, his authorised representative who is required to carry out, or carries out or has carried out the risk analysis and risk management procedures set out in the Annex to Directive 2003/32 shall observe the manufacturer’s obligations set out in those procedures.
(5) Paragraph (4) shall not apply to a relevant device which is not intended to come into contact with the human body or which is intended to come into contact with intact skin only.]
Textual Amendments
F1Reg. 17(4)(5) added (1.4.2004) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(b), 7
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