Dear members, please see new Guidance Document on post-market surveillance of medical devices and in vitro diagnostic medical devices MDCG 2025-10. The guidance was developed in co-operation with the MedTech Europe PMS and Vigilance Working group.
The European Commission has recently published a new Guidance Document on post-market surveillance of medical devices and in vitro diagnostic medical devices (MDCG 2025–10).
This guidance explains how MD and IVD manufacturers must design and run proactive, continuous post-market surveillance systems as part of their quality management, requiring them to systematically collect, analyse and use real-world data throughout a device’s lifetime to confirm safety and performance, update technical documentation, and trigger corrective actions. It clarifies the scope of obligations, how to establish a PMS plan tailored to risk class, how to integrate surveillance with other quality processes, and what data sources and activities are expected to meet the regulatory requirements of MDR and IVDR.
