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The Medical Devices (Amendment) Regulations 2003
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Changes over time for: Section 6
No versions valid at: 01/09/2003
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- 01/04/2004- Amendment
- 01/09/2003
Point in time - 21/10/2013- Amendment
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Yn ddilys o 01/04/2004
Amendment of regulation 13 of the principal RegulationsU.K.
6. In regulation 13 of the principal Regulations (procedures for affixing a CE marking to general medical devices), after paragraph (4) there is added the following paragraphs—
“(5) Notwithstanding that the requirement in paragraph (1) to (4) is satisfied, subject to paragraph (6), where a relevant device is manufactured utilising either animal tissue which is rendered non-viable or non-viable products derived from animal tissue its manufacturer or his authorised representative must—
(a)carry out the risk analysis and risk management procedures set out in the Annex to Directive 2003/32; and
(b)fulfil his obligations under those procedures
before the device may bear a CE marking.
(6) Paragraph (5) 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.”.
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