Great Britain issued Post-market Surveillance (PMS) regulation for medical devices

The new Post-Market Surveillance (PMS) regulation will take effect on June 16, 2025, marking a significant step in enhancing medical device safety.

Key updates include:

Comprehensive Data Collection: Manufacturers are required to gather more detailed data on device performance to ensure better safety monitoring.

Shortened Reporting Timelines: Serious incidents must now be reported more swiftly, enabling faster responses to potential risks.

Summary Reporting: Manufacturers must submit regular summary reports, helping to identify safety concerns at an earlier stage.

Risk Mitigation and Communication: Manufacturers will face clearer responsibilities to mitigate risks and communicate effectively, ensuring better protection for both patients and users.

This regulation is part of broader regulatory reforms designed to elevate the safety of medical devices while providing greater certainty for manufacturers. It builds on feedback from the 2021 consultation and aligns with recommendations from the Independent Medicines and Medical Devices Safety (IMMDS) review, underscoring the commitment to continuous improvement in patient safety.