Guidance

Medical devices: compliance and enforcement of the regulations

Information about the MHRA's duties and how you can report a non-compliant medical device.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 18 December 2014
• Last updated: 17 May 2024
  Show all updates

  1. 17 May 2024

     '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. 1 July 2023

     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. 17 May 2023

     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. 26 February 2019

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

  5. 24 March 2017

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

  6. 1 March 2017

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

  7. 18 December 2014

     First published.

Documents

How we enforce medical device regulations

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Report a non-compliant or suspected counterfeit medical device

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Details

The MHRA is responsible for ensuring that medical devices in the UK comply with legal requirements.

This guidance includes:

• contact details to report a non-compliant medical device
• information on what we do after receiving a complaint
• our routine monitoring role
• the manufacturer’s rights if they have received an enforcement notice