- Latest available (Revised)
- Original (As made)
This is the original version (as it was originally made).
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.”.
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: