On 16 June 2025, the UK’s new Post-Market Surveillance (PMS) Statutory Instrument (SI) for medical devices took effect, establishing a standalone device framework in Great Britain. This overhaul aims to strengthen how devices are monitored once on the market, ensuring patient safety and supporting future rules for approvals and standards.
Enhanced Surveillance Requirements
Under the PMS Regulation, all UK-marketed devices—whether bearing a UKCA or CE mark—must undergo continuous surveillance. Key examples of the new requirements are that manufacturers are required to:
- Monitor real-world safety data and conduct trend analysis across every risk class.
- Report serious incidents within 15 days (half the previous deadline) or shorter depending on the nature of the event.
- Submit Periodic Safety Update Reports (PSURs) within three days of request.
Manufacturer Responsibilities
Device makers must manage risks proactively, investigate user complaints, and notify both regulators and end-users about safety issues. Manufacturers of self-test devices must monitor their devices’ real-world use, investigate complaints, and report serious issues to the MHRA, as required by the PMS SI.
Public and Professional Guidance
Healthcare professionals and the public can verify a device’s registration through the MHRA’s Public Access Registrations Database. To report non-compliant products, contact devices.compliance@mhra.gov.uk.
Source: Medtech Insight (an Informa product)
