A major reform in the regulation of medical devices in Great Britain came into force in16 June 2025. The new rules mark a key step in the UK’s wider effort to modernise how medical devices are monitored after they reach the market. The changes are being implemented by the Medicines and Healthcare products Regulatory Agency (MHRA) as part of its broader strategy to enhance safety and support innovation in healthcare technology.
Under the new Post-Market Surveillance (PMS) regulations, manufacturers are now required to actively track the safety and performance of their devices once in use. This includes collecting real-world data, monitoring for issues, and reporting serious incidents more quickly. The goal is to detect potential risks earlier and respond faster, offering greater protection to patients and the public.
The rules apply to all UKCA- and CE-marked devices placed on the Great Britain market from today onwards. This includes a wide range of technologies used in homes, hospitals, and clinics, such as glucose monitors, prostate-specific antigen (PSA) tests, pacemakers, and hearing implants.
Manufacturers must now have robust systems in place to monitor devices, collect safety data, and report serious incidents to the MHRA within 15 days—down from the previous 30-day requirement. They are also required to submit Field Safety Notices to the MHRA before they are shared with users and provide safety update reports within three days of a formal request. For higher-risk devices, UK-approved bodies will review these reports to ensure a stronger level of oversight.
MHRA Chief Executive Lawrence Tallon said the changes are essential to ensure that regulation keeps pace with advances in medical technology. He stated that the reform is a vital step toward a modern system that puts patient safety first while supporting innovation.
The new framework also includes enhanced requirements for data trend analysis and risk communication. Manufacturers must assess how their devices perform over time and act quickly if safety concerns arise. New trend reporting rules will help both the MHRA and the industry to identify patterns earlier, even in lower-risk devices, allowing earlier intervention when needed.
A revised guidance for manufacturers, first published in January 2025, has been updated based on industry feedback. The MHRA continues to invite further input to ensure the regulations are clear and practical to apply.
This reform is seen as an important milestone in shaping a more responsive and effective regulatory system in the UK. It also sets the stage for further developments, including potential international partnerships, aimed at improving access to safe and effective medical innovations.
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