Devices supplied without valid UKCA/CE conformity markings or certification

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a device safety information alert. The MHRA has become aware of a number of medical devices being supplied on the UK market that do not comply with the requirements of the UK Medical Device Regulations 2002 (UK MDR 2002) or with the EU Medical Devices Regulation (EU) 2017/745 (EU MDR).

While the MHRA has not identified a specific defect or safety concern associated with these products, they do not meet the regulatory requirements for supply on the UK market, meaning assurance regarding their safety, sterility and performance cannot be fully guaranteed.

Further information, advice and an explanation of the identified safety issue can be found on the MHRA website.