Guidance

Medical devices regulations: compliance and enforcement

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

Documents

Details

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 24 March 2017 + show all updates
  1. Change in penalty from fine up to £5,00 per offence to an unlimited fine.
  2. Page title changed and new document added to the page to replace 'RAMS'
  3. First published.