United Kingdom: UK Enacts New Post-Market Surveillance Rules for Medical Devices (w.e.f. 16 June 2025)

As of 16 June 2025, a significant new chapter begins for medical device regulation in Great Britain, marking the first major overhaul of post-market safety rules under the Medicines and Healthcare products Regulatory Agency’s (MHRA) ongoing regulatory transformation.

The newly implemented Post-Market Surveillance (PMS) regulations introduce enhanced responsibilities for medical device manufacturers to actively monitor, assess, and respond to how their devices perform after they have been placed on the market.

A Proactive Approach to Patient Safety

The central aim of these reforms is to strengthen the real-world safety and performance oversight of medical devices, allowing for earlier detection of risks, faster regulatory intervention, and ultimately, stronger protection for patients and healthcare systems.

Applicable to all UKCA- and CE-marked devices introduced into the GB market, from 16 June 2025 onward, the regulation covers a wide range of technologies, including in-vitro diagnostic (IVD) tools like glucose monitors and PSA tests, active implantable medical devices such as pacemakers and cochlear implants, and a variety of clinical and home-use devices.

Key Features of the New PMS Framework

Manufacturers are now required to go beyond passive compliance and implement systematic and proactive monitoring procedures. Here are the most impactful changes introduced:

• Enhanced Real-World Data Collection

Manufacturers must adopt a harmonized approach to collect and assess post-market data from clinical use environments. This improves their ability to detect emerging safety or performance issues before they escalate

• Broader Incident Reporting

The scope of reportable incidents has been expanded to include serious adverse effects, giving the MHRA a more accurate and complete picture of device performance

• Shorter Reporting Timelines

Serious incidents must now be reported to the MHRA within 15 days – down from the previous 30 days and this enables quicker risk mitigation and patient protection.

• Trend and Summary Reporting

Manufacturers must submit trend reports and Period Safety Update Reports (PSURs) on request, within just 3 days. These allow earlier identification of device-related patterns, particularly for lower-risk devices that previously received less regulatory scrutiny

• Stricter Risk Communication

Manufacturers are required to submit Field Safety Notices (communications regarding device safety) for MHRA review before distributing them to users. They must also demonstrate strong internal systems to mitigate risks and promptly alert stakeholders

Supporting Innovation While Ensuring Safety

This new PMS regulation does more than enhance safety, but it also lays a foundation for future reforms aimed at improving international recognition, streamlining market access, and supporting innovation in the UK’s life sciences sector.

Notably, UK Approved Bodies will play a bigger role in overseeing PMS reports for higher-risk devices, ensuring these products receive rigorous and ongoing evaluation.

The MHRA also recognizes the importance of clear guidance for implementation. An updated set of PMS guidance documents – initially published in January 2025 and revised with industry input – continues to support manufacturers as they adapt to the new requirements.

Future Vision

The introduction of the new PMS framework represents a turning point in how the UK balances regulatory agility with patient safety. As manufacturers adjust to these enhanced responsibilities, the MHRA encourages continued collaboration and feedback to ensure successful, practical implementation across the industry.

For device developers, regulatory professionals, and clinical stakeholders, these reforms signal a stronger, more responsive system – one built on transparency, accountability, and a shared commitment to patient well-being.

Source: Medicines and Healthcare products Regulatory Agency (MHRA)