MHRA - First major overhaul of medical device regulation comes into force across Great Britain

16th June 2025

MHRA - First major overhaul of medical device regulation comes into force across Great Britain

From today (16 June 2025), a landmark reform of how medical devices are regulated in Great Britain takes effect, as part of the Medicines and Healthcare products Regulatory Agency’s (MHRA) broader transformation of the UK’s medical device regulatory framework.

The new Post-Market Surveillance (PMS) regulations require device manufacturers to actively track the safety and performance of products already in use. This will help identify potential safety issues earlier and strengthen protection for patients and the public through faster responses to incidents and emerging risks.

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