MDCG publishes guidance on post-market surveillance for medical devices and IVDs
The European Commission’s Medical Device Coordination Group (MDCG) has published new guidance (MDCG 2025-10) clarifying post-market surveillance (PMS) requirements under Regulation (EU) 2017/745 (Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation (IVDR)). The guidance emphasises that PMS should operate as a continuous and proactive process throughout a device’s lifecycle and be fully integrated into manufacturers’ quality management systems. It calls for the active collection and analysis of data, including from scientific literature, registries and the European Database on Medical Devices (EUDAMED), with findings feeding into risk management, clinical evaluation, labelling and corrective actions. Manufacturers must also maintain a device-specific or device-group PMS plan, setting out data collection methods, analysis approaches and predefined thresholds for action.