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. Electronic instructions for use of medical devices: guidance on regulations
   • 14 March 2013
   • Guidance
4. Exceptional use of non-CE marked medical devices
   • 18 December 2014
   • Guidance
5. In vitro diagnostic medical devices: guidance on legislation
   • 19 August 2013
   • Guidance
6. Medical devices: how to comply with the legal requirements
   • 16 August 2013
   • Guidance
7. Medical devices: off-label use
   • 18 December 2014
   • Guidance
8. Medical devices: software applications (apps)
   • 20 June 2018
   • Guidance
9. Medical devices: UK notified bodies
   • 6 August 2018
   • Regulation
10. Medical devices regulations: compliance and enforcement
    • 24 March 2017
    • Guidance
11. Medical devices: Virtual Manufacturing replaces Own Brand Labelling
    • 29 March 2017
    • Guidance
12. Notified bodies for medical devices
    • 22 June 2017
    • Guidance
13. Notify MHRA about a clinical investigation for a medical device
    • 9 October 2018
    • Guidance
14. 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.