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MHRA 2024 Roadmap: UK medical devices regime: closer EU alignment, limited departure from 2022 proposals, phased implementation (post-market surveillance 2024; core regulations 2025), CE marking accepted until 2030

Published on: 27 February 2024

Published by a LexisNexis Life Sciences expert
Legal News
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Article summary

In September 2021, the MHRA opened a consultation (see: LNB News 16/09/2021 90) to reform the UK’s medical device regulatory regime. The government issued its detailed reply in June 2022 (see: LNB News 27/06/2022 48), yet no tangible changes have followed. In January 2024, the MHRA set out a comprehensive Roadmap, with timelines, charting the move towards the future regulatory framework for medical devices, alongside updated guidance on putting forthcoming regulations into practice (see: LNB News 09/01/2024 30)...

No indication of substantive changes to the 2022 regulatory proposals

The key message is that there appears to be no major deviation in substance from the government’s detailed 2022 stance. That said, the publications were not accompanied by draft regulations. The ‘Core Regulations’—which will deliver the principal substantive updates, such as changes to the classification of certain device types, clarification of what is required of economic operators, and the setting of applicable cybersecurity requirements for software as a medical device—are to be taken forward through further stakeholder engagement during 2024...

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