Collection

Regulatory guidance for medical devices

Check the legal requirements you need to meet before you can place a medical device on the market and see how MHRA monitors compliance.

Published 18 December 2014
Last updated 29 March 2017 — see all updates

• From: Medicines and Healthcare products Regulatory Agency

Documents

1. Custom-made medical devices

   • 16 August 2013
   • Guidance

2. Devices which incorporate an ancillary medicinal substance

   • 6 October 2017
   • Guidance

3. Directives bulletin 3: European vigilance system in the UK

   • 1 September 2008
   • Guidance

4. Electronic instructions for use of medical devices: guidance on regulations

   • 14 March 2013
   • Guidance

5. Exceptional use of non-CE marked medical devices

   • 18 December 2014
   • Guidance

6. In vitro diagnostic medical devices: guidance on legislation

   • 19 August 2013
   • Guidance

7. Medical devices: how to comply with the legal requirements

   • 16 August 2013
   • Guidance

8. Medical devices: off-label use

   • 18 December 2014
   • Guidance

9. Medical devices: software applications (apps)

   • 20 June 2018
   • Guidance

10. Medical devices: UK notified bodies

    • 21 February 2018
    • Regulation

11. Medical devices regulations: compliance and enforcement

    • 24 March 2017
    • Guidance

12. Medical devices: Virtual Manufacturing replaces Own Brand Labelling

    • 29 March 2017
    • Guidance

13. Notified bodies for medical devices

    • 22 June 2017
    • Guidance

14. Notify MHRA about a clinical investigation for a medical device

    • 18 June 2018
    • Guidance

15. Regulation of IVDs for self-testing

    • 3 July 2012
    • Guidance

Published 18 December 2014
Last updated 29 March 2017 + show all updates

1. 29 March 2017 Added a link to guidance for manufacturers who don’t design or manufacture devices but place their names on the product.
2. 11 January 2017 Added a link to Medical devices: how to comply with the legal requirements guidance.
3. 16 May 2016 Added new document on devices which incorporate an ancillary medicinal substance
4. 18 December 2014 First published.