Medical devices regulations: compliance and enforcement
- Medicines and Healthcare products Regulatory Agency
- Part of:
- Regulatory guidance for medical devices, Patient safety, and Medical devices regulation and safety
- First published:
- 18 December 2014
- Last updated:
- 24 March 2017, see all updates
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
Updated: 24 March 2017
- Change in penalty from fine up to £5,00 per offence to an unlimited fine.
- Page title changed and new document added to the page to replace 'RAMS'
- First published.