On August 1, local time, the British Medicines and Healthcare products Regulatory Agency (MHRA) issued a statement on the CE mark recognition of medical devices and in vitro diagnostic products.

The release of this statement means that the extended recognition of the CE mark does not apply to medical devices or IVDs.

The government has introduced legislation to amend the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (MDR UK) to broaden the acceptance of CE marked medical devices in the UK market. More specifically, the legislation now allows CE-marked medical devices to be placed on the UK market within the following periods:

1. Ordinary medical devices that comply with the EU Medical Devices Directive (EU MDD) or the EU Active Implantable Medical Devices Directive, with a valid declaration and CE marking, can be placed on the UK market until the certificate expires or 30 June 2028 day.

2. In vitro diagnostic medical devices (IVD) that comply with the EU In Vitro Diagnostic Medical Device Directive (EU IVDD) can be placed on the UK market until the certificate expires or before June 30, 2030.

3. General medical devices that comply with the EU Medical Device Regulation (EU MDR), including custom-made devices and IVDs that comply with the EU In Vitro Diagnostic Medical Device Regulation, can be placed on the UK market before June 30, 2030.