Guidance note on the regulation of medicines,medical devices and clinical trials if there is no deal

Released: Friday 4th January 2019

Following the consultation on how medicines, medical devices and clinical trials would be regulated in a no-deal scenario, The UK Government has issued updated guidance setting out the UK’s proposed arrangements for regulation if we leave the EU on 29 March 2019 with no deal.

For medical devices, the key arrangements include:

● for a time-limited period, devices that have a CE mark from a notified body based in the UK or an EU country will continue to be recognised by UK law and allowed to be placed on the UK market
● the expansion of the MHRA’s registration system to all classes of medical device.

Further detailed guidance is available here.

Please note that these proposals are still subject to parliamentary approval of the relevant statutory instruments that are required to bring these proposals into law.


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