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

Documents

Regulation on accreditation and market surveillance (RAMS)

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Detail

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