- Latest available (Revised)
- Original (As made)
The Medical Devices (Amendment) Regulations 2003
You are here:
- UK Statutory Instruments
- 2003 No. 1697
- Regulation 7
What Version
Opening Options
Status:
This is the original version (as it was originally made).
Amendment of regulation 17 of the principal Regulations
7. In regulation 17 of the principal Regulations (manufacturers etc. and conformity assessment procedures for general medical devices), after paragraph (3) there is added the following paragraphs—
“(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.”.
Options/Help
Print Options
PrintThe Whole Instrument
PrintThis Section only
Legislation is available in different versions:
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.
Opening Options
Different options to open legislation in order to view more content on screen at once
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as enacted version that was used for the print copy
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as made version that was used for the print copy
- correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.