Would you know how to report a counterfeit medical device?

The MHRA has updated information on their enforcement duties with medical devices.

The guidance includes:

  • The email address for which non-compliant medical devices can be reported to
  • The MHRAs responsibilities and actions once a complaint has been received
  • Details on enforcement notices issued by the MHRA and a manufacturer’s rights if they are issued one.

If you suspect a non-compliant medical device for sale in the UK (including potential counterfeit devices), you can email devices.compliance@mhra.gsi.gov.uk. Your email should include the name and address of the manufacturer/seller of the device and any details of the suspected breach of regulation.

Click here to view the complete updated guidance.