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 email@example.com. 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.