The Guidance Notes are intended for manufacturers and users of medical devices.
For guidance about individual publications, please contact:
European & Regulatory Affairs
Medicines and Healthcare products Regulatory Agency
5 Magenta
151 Buckingham Palace Road
Victoria
London
SW1W 9SZ
Telephone: 020 3080 7300
Email: era@mhra.gsi.gov.uk
A 24 hour message service for obtaining copies of guidance notes is also available, please ring and leave a message on 020 7084 3203.
Latest guidance on EC Medical Devices Directives
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04 Aug 2010 | Guidance Note 1 - Guidance Notes for Manufacturers on Clinical Investigations to be carried out in the UK
(741Kb)
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18 Sep 2009 | Guidance note 20 – Borderlines with medical devices
(108Kb)
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27 Jul 2009 | Guidance Note 3 - Information for clinical investigators
(67Kb)
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03 Jun 2008 | Guidance Note 6 - Requirements for UK Notified Bodies
(181Kb)
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12 Mar 2008 | Guidance Note 10 - Guidance Notes for Manufacturers of Dental Appliances (Custom Made Devices)
(113Kb)
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30 Jan 2008 | Guidance Note 8 - Guidance Notes for the Registration of Persons Responsible for Placing Devices on the Market Appendix A and B
(65Kb)
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27 Feb 2007 | Registration Form RG2 - for the Registration of Persons Responsible for Placing Devices on the Market
(275Kb)
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24 Oct 2006 | Guidance Note 17 - Guidance Notes for Manufacturers on Statistical Considerations for Clinical Investigations of Medical Devices
(115Kb)
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06 Jun 2006 | Guidance Note 7 - Guidance Notes for Manufacturers of Class 1 Medical Devices
(118Kb)
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02 May 2006 | Registration Form RG3 - for the registration of Persons Responsible for Placing In Vitro Diagnostic Medical Devices on the Market
(256Kb)
