On December 2025, DG SANTE published MDCG 2025-10, a guidance document on post-market surveillance (PMS) under the MDR/IVDR.
The guidance describes:
- The expected PMS system within the manufacturer’s QMS (risk-based and appropriate to device type);
- What a PMS plan should cover (including proactive data collection and defined methods);
- Core PMS steps: sources → collection → analysis → conclusions/actions;
- How PMS information should continuously inform risk management, design and manufacturing, clinical/performance evaluation, labelling/IFU updates, summary of safety and (clinical) performance, CAPA/ field safety corrective actions, usability, performance and safety of the device, PMS of other devices and trend reporting.
More info, here.