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
    • Guidance
  2. Devices which incorporate an ancillary medicinal substance
    • Guidance
  3. Directives bulletin 3: European vigilance system in the UK
    • Guidance
  4. Electronic instructions for use of medical devices: guidance on regulations
    • Guidance
  5. Exceptional use of non-CE marked medical devices
    • Guidance
  6. In vitro diagnostic medical devices: guidance on legislation
    • Guidance
  7. Medical devices: how to comply with the legal requirements
    • Guidance
  8. Medical devices: off-label use
    • Guidance
  9. Medical devices: software applications (apps)
    • Guidance
  10. Medical devices: UK notified bodies
    • Regulation
  11. Medical devices regulations: compliance and enforcement
    • Guidance
  12. Medical devices: Virtual Manufacturing replaces Own Brand Labelling
    • Guidance
  13. Notified bodies for medical devices
    • Guidance
  14. Notify MHRA about a clinical investigation for a medical device
    • Guidance
  15. Regulation of IVDs for self-testing
    • Guidance
Published 18 December 2014
Last updated 29 March 2017 + show all updates
  1. Added a link to guidance for manufacturers who don’t design or manufacture devices but place their names on the product.
  2. Added a link to Medical devices: how to comply with the legal requirements guidance.
  3. Added new document on devices which incorporate an ancillary medicinal substance
  4. First published.