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.
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A public consultation on the UKCA marking for medtech products is anticipated later in the year. Medtech industry representatives are part of the UK regulator’s advisory team.
The UK responsible person is the UK equivalent of the Authorized Representative in the EU. MedTech Europe’s Jesús Rueda gives an update on the early experiences of medtech manufacturers seeking to comply with the UK’s new standalone regulations.
The MHRA has published more guidance on UKRPs and UK product registrations to help medtech companies navigate the new system and continue to reach the market.