As we approach the end of the Brexit transition period on December 31st 2020 it is important to consider the implications on the Medical Device Industry of the UK leaving the EU. UK Medical Device market regulations, currently the responsibility of the EU system, will be taken over by The Medicines and Healthcare products Regulatory Agency (MHRA). The negotiations between the UK and the EU are ongoing and there continues to be much uncertainty facing the Medical Device Industry. That said, the MHRA have published initial guidance which will come into effect on January 1st 2021. The key requirements highlighted are as follows:
• Great Britain will continue to accept certificates issued by EU-recognised bodies until June 30th 2023; however, after January 1st 2021 UK Notified Bodies will no longer be able to issue CE certificates.
• Great Britain will continue to recognise the CE marking until 30th June 2023, after which the UKCA (UK Conformity Assessed) marking will be required.
• Manufacturers launching medical devices in the UK market will be required to register with the MHRA.
Different rules will apply to Northern Ireland who will have special status. The full list of requirements for both Great Britain and Northern Ireland, as outlined by the MHRA, can be found on the UK Government’s site here. We will continue to keep you up to date on our news pages regarding regulatory guidance as new developments emerge.
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