Innovative approaches to Med Tech regulatory reform

28th November 2025

Innovative approaches to Med Tech regulatory reform

Summary: The MHRA’s latest MedRegs blog outlines several initiatives to update and strengthen med-tech regulation. These include trialling an AI-powered tool to support staff with technical queries, progressing revised guidance on the Health Institution Exemption following stakeholder feedback, and updating the list of Designated Standards to ensure it keeps pace with technological change. The agency is also finalising a new statutory instrument for pre-market device regulation and preparing a consultation on proposals to allow indefinite recognition of CE-marked devices, aiming to streamline market access while maintaining safety.

Link: Innovative approaches to Med Tech regulatory reform

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