EU - Guidance on Post-Market Surveillance of Medical Devices and In Vitro Diagnostic Medical Devices

The Medical Device Coordination Group (MDCG) has published the MDCG 2025-10 Guidance on Post-Market Surveillance (PMS) of Medical Devices and In Vitro Diagnostic Medical Devices (IVDs) in December 2025.

This guidance outlines the requirements for manufacturers to establish and maintain a Post-Market Surveillance (PMS) system as part of their Quality Management System (QMS), in compliance with Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). 

The PMS system must actively and systematically collect, analyze, and act upon data regarding the safety, performance, and quality of devices throughout their entire lifecycle, ensuring compliance with EU regulations and supporting continuous improvement and patient safety.​