New regulations have come into effect in the UK which place a greater emphasis on medical device manufacturers to monitor the safety and performance of their products.

The new Post-Market Surveillance (PMS) regulations came into effect from Monday (16 June) requiring device manufacturers to actively track the safety and performance of products already in use. The reforms, which are a part of a wider effort by the Medicines and Healthcare products Regulatory Agency (MHRA) to overhaul the UK’s medical device regulatory framework, are intended to identify potential safety issues earlier and to 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 market in Great Britain after 16 June. This includes in vitro diagnostic devices, active implantable medical devices as well as other technologies used in a clinical setting and within the home.

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.

“As innovation in health technologies accelerates, regulation must keep pace,” Lawrence Tallon, chief executive of the MHRA said. “Today’s reform is a critical step in ensuring safety standards evolve alongside this progress. By strengthening oversight of device 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.”

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, MHRA adds. These rules will require manufacturers to regularly summarise and assess device performance over time.

As well as the reforms on medical device surveillance, the UK government has this week announced plans to make it easier for individuals to volunteer to participate in clinical trials. Patients will be able to sign up to participate in trials via the National Institute for Health and Care Research (NIHR) Be Part of Research service on the NHS app, where they will be able to browse and select trials best suited to their interests and needs.

Eventually this will automatically match patients with studies based on their own health data and interests, sending them push notifications to their devices about relevant trials that they may wish to sign up to participate in.

NIHR is also launching a recruitment drive to find as many volunteers for trials as possible, including those from underrepresented groups including young people, Black people and people of South Asian heritage.