Medical devices regulations: compliance and enforcement

Information on MHRA's enforcement duties and how to report a non-compliant medical device.



MHRA has the responsibility to check that medical devices in the UK comply with legal requirements.

This guidance includes:

  • contact details to report a non-compliant medical device
  • information on MHRA’s enforcement duties after receiving a complaint
  • MHRA’s routine monitoring role
  • the manufacturer’s rights if they have received an enforcement notice
Published 18 December 2014
Last updated 17 May 2024 + show all updates
  1. 'Medical devices: the regulations and how we enforce them' updated to reflect changes to the legislation relating to MHRA’s investigatory and enforcement powers.

  2. This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.

  3. Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.

  4. Added a link to new guidance on medical devices regulation in a no deal scenario.

  5. Change in penalty from fine up to £5,00 per offence to an unlimited fine.

  6. Page title changed and new document added to the page to replace 'RAMS'

  7. First published.