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MHRA Highlights Intention to Extend UKCA Date by 12 Months (1)

Topic : Type : Briefing

The MHRA has published its intention to set out UK legislation that will extend the standstill period during which CE marking is accepted in the UK for one more year to July 2024. According to MHRA, the planned transitions will then start from when the new regulations come into force, alongside new post-market surveillance requirements. 

It must be stressed that this is not in legislation yet. However, this is an important step by MHRA, and provides a degree of reassurance that we will now progress in-line with the government proposals published in June.

Though of course welcome, and we are glad to hear that our calls are being listened to, major concerns do still remain. One cliff edge may be averted, but progress over the coming months must be rapid and decisive if we are to avert a similar cliff edge scenario one year from now. There is also limited Approved Body capacity to service the sector, and this must be addressed as a matter of urgency. 

ABHI continues to advocate for a clearer roadmap for the future requirements for legislation and supporting infrastructure. The Life Sciences Vision rightly calls out the need to ensure the development of a best in class regulatory regime, and it is absolutely critical that we meet this ambition in order to position the UK as an attractive market to develop, manufacture and supply health technologies.