The Medical Device Coordination Group (MDCG) has released MDCG 2025-10 – Guidance on Post-Market Surveillance (PMS) of Medical Devices and In Vitro Diagnostic Medical Devices (Dec 2025). This document supports manufacturers in understanding and implementing robust PMS systems under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
The guidance explains what a PMS system must include, how to plan and operate it throughout the lifecycle of a device, and how PMS interacts with other quality management system (QMS) processes.
🔍 Key points:
Describes the PMS system obligations required under MDR/IVDR — proportional to the device’s risk profile and appropriate for its intended use. Outlines how manufacturers must establish and maintain a PMS plan as part of technical documentation.
Details the main PMS activities: identifying information sources, collecting and analysing data, drawing conclusions and defining corrective actions.
Clarifies how PMS data feeds into risk management, clinical/performance evaluation, and continuous improvement of device safety and performance.
Includes annexes summarising MDR/IVDR PMS obligations and scenarios showing how PMS outputs should update related QMS processes.
📘 Guidance document link:
https://lnkd.in/erp9QfyC