Medical Device CE Marks Will Be Recognized in UK Through June 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said that devices with the CE mark will continue to enjoy UK recognition until June 30, 2023.
However, beginning Jan. 1, 2021, after the transition to the UK’s exit from the EU formally ends, any medical device, in vitro diagnostic or custom-made device “will need to be registered with the MHRA before being placed on the Great Britain market,” MHRA said.
The CE mark signifies that products sold in the European Economic Area (EEA), which largely overlaps with the European Union, have been assessed to meet high safety, health and environmental protection requirements.
Certificates issued by EEA-based Notified Bodies — the independent organizations that award certifications such as the CE mark — will continue to be valid in the UK until June 30, 2023.