Overhaul of medical device regulations in UK takes effect

The Medicines and Healthcare products Regulatory Agency’s (MHRA) has announced a major overhaul of how medical devices are regulated in Great Britain as part of a wider transformation of the UK’s medical device regulatory framework.

Under the new Post-Market Surveillance (PMS) regulations device manufacturers are required to actively track the safety and performance of products already in use to help identify potential safety issues earlier.

The regulatory reform applies to all UKCA- and CE-marked devices placed on the GB market after 16 June 2025, including vitro diagnostic devices (IVD), such as glucose monitors, active implantable medical devices including pacemakers, and technologies used across hospitals, clinics and at home.

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.”

The regulations will ensure that 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.

Key changes introduced by the new PMS device regulation include:

• Enhanced collection of real-world data – manufacturers must take a harmonised approach to gather and assess data on how their devices perform in everyday use, improving the ability to detect safety and performance issues.
• Expanded scope for incident reporting – serious incidents relating to side effects are now reportable, providing a more comprehensive picture of device performance.
• Shorter timelines for reporting serious incidents – serious incidents must be reported to the MHRA more quickly, allowing for faster regulatory action to protect patients.
• Trend reporting and summary reporting – new data analysis reporting options will support earlier detection of trends without overburdening manufacturers or the regulator.
• Clearer duties for risk mitigation and communication – manufacturers face stronger requirements to assess and manage risks, and to notify users promptly when safety issues arise.

Guidance to help medical device manufacturers prepare for the regulatory changes was published in January 2025 by the MHRA, and has been updated following industry feedback and the new regulations coming into force.

In June 2024, the MHRA published guidance to support better transparency around AI and machine learning-driven medical devices, with a focus on how data is used and acted on.

This followed the publication of the agency’s strategic approach to AI policy paper in April 2024.