GOV.UK
Guidance
Report a non-compliant or suspected counterfeit medical device
Updated 26 February 2019
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Report a non-compliant or suspected counterfeit medical device
If you believe that a non-compliant medical device is available for purchase in the UK, please email us on devices.compliance@mhra.gov.uk with the following information:
- the name and address of the manufacturer or seller
- details of the product involved
- the breach of the alleged regulations
- any evidence you might have that supports the allegation
If you have reason to believe that a counterfeit (fake) medical device is available for purchase then please report this via our yellow card scheme or email us on devices.compliance@mhra.gov.uk.
We will assess the evidence to see if a breach of the regulations has occurred and then perform a risk assessment to determine what level of investigation is required.
If you report to us, we will not disclose your identity as we are subject to the confidentiality provisions contained within the Enterprise Act 2002. However, these provisions also mean that we cannot give you any details of any assessment or investigation we undertake in relation to your report. We will only be able to reveal this information under criminal procedure rules in a court case.
You can find information on how your report will be acted on in our guidance titled “Medical Devices: the regulations and how we enforce them”