New Post-Market Surveillance (PMS) regulations have taken effect across Great Britain.

Medical device manufacturers will be required to proactively monitor the safety and performance of their products once on the market.

The changes are 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.

The changes are intended to help identify potential safety issues earlier and strengthen protection for patients and the public through faster responses to incidents and emerging risks.

The reforms apply to all UKCA- and CE-marked devices placed on the GB market after 16 June 2025.

The changes include enhanced collection of real-world data; expanded scope for incident reporting; shorter timelines for reporting serious incidents; trend reporting and summary reporting; and clearer duties for risk mitigation and communication.

Lawrence Tallon, Chief Executive of the MHRA, said: "As innovation in health technologies accelerates, regulation must keep pace. Today’s reform is a critical step in ensuring safety standards evolve alongside this progress.

"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."