Medical devices regulations: compliance and enforcement

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

From:
Medicines and Healthcare products Regulatory Agency
Published
18 December 2014
Last updated
17 May 2024 — See all updates
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Medical devices: the regulations and how we enforce them

Report a non-compliant or suspected counterfeit medical device

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Exemptions from devices regulations during the coronavirus (COVID-19) outbreak Regulatory status of equipment being used to help prevent coronavirus (COVID-19)

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