First major overhaul of medical device regulation comes into force across Great Britain
- kenashman
- Jun 17
- 1 min read
MHRA published 16 June 2025
New Post-Market Surveillance (PMS) regulations have taken effect across Great Britain, requiring medical device manufacturers to proactively monitor the safety and performance of their products once on the market.
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.
Today’s reform applies to all UKCA- and CE-marked devices placed on the GB market after 16 June 2025. This includes in vitro diagnostic devices (IVD), such as glucose monitors and prostate specific antigen (PSA) tests; active implantable medical devices, including pacemakers and hearing implants; and range of technologies used across hospitals, clinics, and at home.
The regulations will ensure all manufacturers have an effective system in place to monitor devices once they are in use, collect comprehensive safety data, report serious incidents, and take swifter action when issues arise. New trend reporting requirements will help the MHRA and industry spot patterns and intervene earlier to protect patients.
