If you have any concerns about a medical device being placed on the market without complying with the Medical Devices Regulations please let the Devices Compliance Unit know through the following mailbox: devices.compliance@mhra.gsi.gov.uk
The sort of information we would require to pursue allegations of non-compliance would be as follows:
- the manufacturers name and address
- details of the product involved
- the breach of the regulations alleged
- any evidence you might have to provide grounds for investigation.
Once this information has been received the information will be risk assessed to determine whether an investigation is warranted.
Allegations of non-compliance will be treated confidentially. All such referrals are investigated and resolved taking into account the principles of proportionality and risk. Unfortunately the confidentiality requirement works both ways and we can't let complainants have details of any ongoing investigation with a third party.
However, appropriate action will be taken to resolve any breaches identified. This may range from prosecution where there is a serious risk to public health or repeated non-compliance to other forms of less noticeable compliance action while the product remains on the market in less serious cases.
Details of the MHRA's powers and your rights are contained in our enforcement strategy:
Enforcement policy - Compliance inspection and action - Your rights
