Publications

The Medical Device Coordination Group (MDCG) has published a Guidance MDCG 2025-10 on post-market surveillance (PMS) for medical devices and in vitro diagnostic medical devices, providing comprehensive clarification on expectations under the MDR (EU) 2017/745 and IVDR (EU) 2017/746.

The guidance reinforces PMS as a continuous, proactive, and systematic process, fully embedded within the manufacturer’s Quality Management System. Manufacturers are expected not only to collect post-market data, but also to actively seek information from multiple sources, including complaints, vigilance data, scientific literature, registries, user feedback, and post-market clinical or performance follow-up activities.

A key focus of MDCG 2025-10 is the PMS plan, which must be proportionate to device risk and clearly define data sources, methods of analysis, indicators, thresholds, and escalation criteria. The document also details how PMS outputs must feed into risk management, clinical/performance evaluation, CAPA, labeling updates, and benefit–risk reassessment, ensuring real-world evidence continuously supports device safety and performance throughout its lifetime.

Importantly, the guidance clarifies PMS obligations across all device classes, including custom-made devices, and outlines expectations for PMS reports and Periodic Safety Update Reports (PSURs). Overall, MDCG 2025-10 strengthens regulatory consistency and supports manufacturers in maintaining compliance while enhancing patient and user protection.

RPN will provide any further update and is available to provide full support for post-market surveillance and regulatory compliance activities.