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MHRA Offers Medtechs Extra Transition Time For UK Regulatory System Compliance

UK regulator to allow three- and five-year transitions for CE-marked devices and diagnostics

 
• By Ashley Yeo

26 June saw the release finally of the UK government’s official response to the MHRA’s 2021 consultation on its post-Brexit medical devices regulatory framework. The considered response, held up by political and internal timing issues, represents an implementation plan for reform of the system. Crucially it allows industry extra compliance time.

Closeup of mobile phone screen with logo lettering of UK MHRA agency, serum vials and syringe background.
• Source: Alamy

Section 15 – Transitional Arrangements – was the part of the UK government’s plan for future medtech regulation that most readers rushed to when this long-awaited response to the Medicines and Healthcare products Regulatory Agency’s (MHRA) consultation was published on 26 June.

The MHRA will have a lot on its mind this week, including the release of its it “One Agency” brand identity, as flagged last week by agency chief executive June...

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