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.

The 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.

Lawrence Tallon, chief executive of the MHRA, said: ‘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.

‘This represents an important milestone in our work in building a modern, responsive regulatory system – one that puts patient safety first, while also supporting innovation in life sciences and medical technologies across the UK.'

In addition, the new PMS regulation lays the groundwork for future reforms, including potential international recognition routes, designed to support improved access to safe and effective innovations.