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The Uk Government's official website has announced that from 1 January 2021, the UK Medicines and Healthcare Products Regulatory Authority (MHRA) will assume responsibility for the UK medical device market currently operating through the EU system.
, the first day of Brexit, medical devices will begin their own independent MHRA certification, which will continue until 30 June 2023.
other major changes are as follows: from 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered in the MHRA before they can be placed on the UK market.
MHRA will only be registered on devices where the manufacturer has a place of business in the UK and registration will have a grace period: Class III and IIb implants and all active implantable medical devices for 4 months, other IIb and all IIa devices for 8 months, Class I devices for 12 months or more, and the grace period of more than 12 months does not apply to Class I devices and generic IVD manufacturers currently required to register with MHRA.
if you are a manufacturer outside the UK and want to bring your equipment to the UK market, you need to have a UK head responsible for the products in the UK.
addition, as of 1 January 2021, the EU Medical Device Regulation (MDR) and the EU In vitro Diagnostic Medical Device Regulation (IVDR) will be fully applied in EU member states on 26 May 2021 and 26 May 2022, respectively.