MDCG 2025-10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices

The Medical Device Coordination Group (MDCG) has released its new guidance: “Post-Market Surveillance of Medical Devices and In Vitro Diagnostic Medical Devices”.

This document provides manufacturers with a clear roadmap to strengthen compliance under Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) by:

• Defining a robust PMS system integrated into the Quality Management System (QMS), proportionate to device risk;
• Detailing PMS plan requirements: proactive data collection, trend reporting, indicators for benefit-risk reassessment, and PMCF/PMPF integration;
• Clarifying interactions with other QMS processes, including risk management, clinical/performance evaluation, and SS(C)P updates;
• Driving continuous compliance through systematic analysis of real-world data and timely corrective or preventive actions.

Bottom line: PMS is not just a regulatory obligation, it’s a strategic tool to ensure safety, performance, and innovation throughout the device lifecycle.

DOWNLOAD THE GUIDANCE MDCG 2025-10