Device manufacturers must now track the safety and performance of products already in use to help identify potential safety issues earlier.

A landmark reform of how medical devices are regulated in Great Britain has taken 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 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.

The reform applies to all UKCA- and CE-marked devices placed on the British market after 16 June. 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 a range of technologies used across hospitals, clinics, and at home. 

Robust framework

Manufacturers are now required to collect and assess real-world safety and performance data; report serious incidents to the MHRA within 15 days (previously 30); submit essential communications on patient safety (Field Safety Notices) to the MHRA for review before sharing with users; and provide PMS Reports or Periodic Safety Update Reports (PSUR) within three days of request. For higher-risk devices, UK-approved bodies will monitor these reports ensuring these products receive a higher level of scrutiny.

The introduction of new data analysis reporting requirements will apply to all medical devices but are particularly valuable for improving oversight of lower-risk devices. These rules will require manufacturers to summarise and assess device performance regularly

“By strengthening oversight of devices once they’re in use and setting clearer expectations for manufacturers, these new regulations provide a robust framework for identifying risks earlier and responding to protect patients,” said Lawrence Tallon, chief executive of the MHRA.