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Medtech Industry’s Wishlist For MHRA’s New UK Regulatory Structure

Convergence with EU regulation, enhanced patient safety and speedy delivery of innovation preoccupy UK medtechs going into 2022

 
• By Ashley Yeo

The UK's medtech regulatory consultation has closed and the MHRA must now assess the views of stakeholders on the 465 questions designed to help shape the foundations of a future-proofed regulatory system. But time is tight, as speakers at the ABHI’s annual regulatory conference were at pains to stress.

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The 10-week consultation on the UK’s standalone medtech regulatory system closed on 25 November. The clock then immediately restarted for the Medicines and Healthcare products Regulatory Agency (MHRA) in its task of encapsulating and consolidating into draft legislation the key views and findings submitted by stakeholders.

That, in turn, must be signed into law before 30 June 2023 – the current date that the UKCA marking will have sole validity in Great Britain, the grace period...

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