First major overhaul of medical device regulation comes into force across Great Britain
Source: gov.uk (2025-06-16)

New Post-Market Surveillance (PMS) regulations have taken effect across Great Britain, requiring medical device manufacturers to proactively monitor the safety and performance of their products once on the market.

From today (16 June 2025), a landmark reform of how medical devices are regulated in Great Britain takes effect, as 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. This will help identify potential safety issues earlier and strengthen protection for patients and the public through faster responses to incidents and emerging risks.

Today’s reform applies to all UKCA- and CE-marked devices placed on the GB market after 16 June 2025. This includes in vitro diagnostic devices (IVD), such as glucose monitors and prostate specific antigen (PSA) tests; active implantable medical devices, including pacemakers and hearing implants; and range of technologies used across hospitals, clinics, and at home.

The regulations will ensure 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.

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 new PMS regulation lays the groundwork for future reforms, including potential international recognition routes, designed to support improved access to safe and effective innovations. This is part of the UK’s broader commitment to a regulatory framework that supports both patient safety and innovation in life sciences.

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 3 days of request. For higher risk devices, UK approved bodies will monitor these reports ensuring these products receive a higher level of scrutiny.

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

Comprehensive guidance for manufacturers was published in January 2025, and has been updated following valuable industry feedback. The MHRA welcomes feedback to ensure ongoing clarity and alignment with practical implementation needs.

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.
Notes to editors

For a summary of the key changes to the regulation, see the Implementation of Future Regulations document (https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations#post-marketsurveillance-requirements).

These new measures build on recommendations from the Independent Medicines and Medical Devices Safety (IMMDS) Review (https://www.immdsreview.org.uk/) and respond to strong support for clearer and more robust PMS requirements to improve patient and public safety.

The MHRA’s PMS implementation guidance (https://www.gov.uk/government/collections/medical-devices-guidance-for-manufacturers-on-vigilance) sets out how the new requirements apply across different types of devices and offers information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.

The new implementation guide for Manufacturers Online Reporting Environment (MORE) (https://www.linkedin.com/posts/medicines-and-healthcare-products-regulatory-agency_we-have-published-new-guidance-to-help-activity-7329101074089291777-VV-9?utm_source=share&utm_medium=member_desktop&rcm=ACoAAA_ZGjUBJWZKApyj_pN0w-ap_kqSHeKDwSI) clarifies the changing data requirements and timelines for compliance, before the new post-market surveillance regulations for medical devices come into effect on 16 June 2025.

The Medical Devices (Post-Market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (https://www.legislation.gov.uk/uksi/2024/1368/contents/made) became law on 16 December 2024 and take effect from 16 June 2025, following a six-month implementation period.

In October 2024, we announced that a Statutory Instrument had been laid in Parliament, setting out the first steps in delivering medical device regulatory reform and strengthening patient safety (https://www.gov.uk/government/news/statutory-instrument-laid-in-parliament-sets-out-first-steps-in-delivering-medical-device-regulatory-reform-and-strengthening-patient-safety).

The Medical Devices (Post-Market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (https://www.legislation.gov.uk/uksi/2024/1368/contents/made) became law on 16 December 2024 and take effect from 16 June 2025, following a six-month implementation period.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
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