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…
