UKCA Mark Will Be The Post-EU Route To The British Medtech Market In January 2021

Brexit transition-end rules decided for UK market access

New MHRA guidance says the EU CE marking will continue to be used for devices and diagnostics in Great Britain until June 2023, and thereafter a standalone regulatory system will come into place.

Broken chain

New guidance from the from the UK Medicines and Healthcare products Regulatory Agency (MHRA) says that Great Britain will continue to use and recognize the CE-marking on devices and in vitro diagnostics until 30 June 2023. After that, companies accessing the home device and diagnostics markets will need to affix a new “UKCA” mark on devices.

The guidance, issued on 1 September, brings clarity regarding future use of the CE marking after the end of the UK’s transition out of the EU on 31 December.

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