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UK MHRA Gives CE-Marked Devices More Breathing Space In GB

Core Aspects Of Future Regime For Medical Devices To Apply From July 2025

 
• By Ashley Yeo

The long-awaited extension of the UK MHRA’s standstill period for CE-marked devices circulating on the Great Britain market was announced in late April, offering new transition deadlines that go beyond the one extra year promised by the agency in fall 2022. Industry is studying the implications.

Parliament

Pragmatism has won the day in the issue of the time allowed by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for companies to comply with the future system of medical device regulation in Great Britain (GB).

The originally-stated deadline of July 1 2023 was arriving too fast for compliance – a fact acknowledged by the MHRA in fall 2022 when it promised to prolong the “standstill"...

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