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| 1 minute read

Will the UK MDR June 2023 deadline be abandoned?

Some of you are likely aware that the Medicines and Healthcare products Regulatory Agency's (MHRA) website claims that the CE Mark will cease to be recognised in the UK from 30 June 2023, following a planned update to the UK's medical devices regulatory framework.

It has become increasingly clear that this 30 June 2023 deadline must be fictitious, at least in the way it is presented on the MHRA website. That date is just over 8 months away, and we don't even have any draft legislation or accompanying guidance for the updated regulatory framework yet. Industry could not reasonably be expected to replace all of its CE Marks with UKCA Marks in such a short period of time.       

It seems that the MHRA agrees with us, as we are now hearing rumours that the 30 June 2023 deadline will be abandoned imminently. It is unclear to us whether these rumours mean that the MHRA simply intends to update its website to remove references to the obviously unviable deadline, or whether the MHRA is actually planning to delay the introduction of the UK's new medical devices regulatory framework .

Nothing is confirmed yet, but one thing is clear: none of this is going to happen until the country gets a Secretary of State for Health...

Manufacturers of medical devices can use either the UKCA marking or the CE marking on devices they place on the GB market until 30 June 2023. From 1 July 2023, a UKCA marking will be required in order to place a device on the Great Britain market.


health tech, life sciences, life sciences regulatory, technology