Report a non-compliant medical device: enforcement process
- 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
Information on MHRA's enforcement duties and how to report a non-compliant medical device.
PDF, 103KB, 11 pages
This file may not be suitable for users of assistive technology. Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email firstname.lastname@example.org. Please tell us what format you need. It will help us if you say what assistive technology you use.
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