New UK Medical Device Surveillance Rules Now in Force

Major regulatory changes for medical device manufacturers have come into effect across the UK, marking a significant step forward in patient safety and post-market monitoring.

From 16 June 2025, new Post-Market Surveillance (PMS) regulations require all manufacturers placing UKCA- and CE-marked devices on the market in Great Britain to actively monitor the safety and performance of their devices already in use. This includes in vitro diagnostics, active implantables, and other medical technologies used in both clinical and home environments.

The updated framework—part of an ongoing overhaul by the Medicines and Healthcare products Regulatory Agency (MHRA)—is designed to detect potential safety issues earlier and ensure faster, more effective responses to emerging risks.

Key Changes at a Glance:

• Real-world data collection on safety and performance is now mandatory.
• Serious incidents must be reported to MHRA within 15 days, halving the previous 30-day timeframe.
• Field Safety Notices must now be submitted to MHRA for approval prior to dissemination.
• PMS Reports and Periodic Safety Update Reports (PSURs) must be made available to MHRA within three days upon request.
• Approved Bodies will monitor reports for higher-risk devices, ensuring enhanced scrutiny.

MHRA Chief Executive Lawrence Tallon described the reforms as a “critical step” in building a modern and responsive system:

“As innovation in health technologies accelerates, regulation must keep pace. These new regulations strengthen oversight of devices in real-world use and support a safer environment for patients across the UK.”

The reforms are also expected to improve long-term performance monitoring, particularly for lower-risk devices, where trends may emerge more gradually.

In parallel, the UK government has also launched an initiative to boost clinical trial participation. Patients can now sign up via the NHS App through the NIHR’s Be Part of Research platform. Over time, the service will begin matching users to relevant trials based on their health profile and interests.

What This Means for the Healthcare Technology Community

These new surveillance regulations carry significant implications for everyone involved in the medical technology lifecycle—from design and distribution through to daily use and ongoing maintenance.

• Biomedical engineers and clinical technology managers will need to incorporate real-world performance data and updated reporting procedures into their risk management and servicing workflows.
• Procurement professionals must now consider compliance with PMS regulations as a core component of their sourcing and supplier evaluation processes.
• Clinical teams and operating theatre staff will benefit from improved transparency and safety data, ensuring they can continue to rely on trusted devices in high-pressure environments.
• Healthcare IT and connectivity specialists may be required to support system integrations that allow for the seamless reporting and tracking of device data in clinical settings.
• Importers and distributors will need to navigate stricter reporting timelines and documentation expectations to ensure continued access to the UK market.

To support all professionals impacted by these changes, EBME Expo 2026 will feature targeted conference sessions across all five CPD-accredited conference stages - including the EBME Conference, Operating Theatre Conference, Procurement Conference, Medical Devices Connectivity Conference, and Training Conference. These sessions will explore regulatory compliance, incident reporting, and the evolving role of real-world data in medical device safety.