Medicines, medical devices and blood regulation and safety – 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.

Contents

  1. Documents

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

    • Detailed guide

  6. In vitro diagnostic medical devices: guidance on legislation

    • Guidance

  7. Medical devices: off-label use

    • Guidance

  8. Medical devices: software applications (apps)

    • Guidance

  9. Medical devices: UK notified bodies

    • Regulation

  10. Notified bodies for medical devices

    • Guidance

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

    • Detailed guide

  12. Regulation of IVDs for self-testing

    • Guidance

  13. Report a non-compliant medical device: enforcement process

    • Guidance
Published:
Updated:

+ full page history

Added new document on devices which incorporate an ancillary medicinal substance
First published.
From:
Medicines and Healthcare products Regulatory Agency