EU MDCG Issues Guidance on Post-Market Surveillance Under MDR, IVDR

By Amelia Boldrick and Elizabeth Pugh

This month, the European Union Medical Device Coordination Group (MDCG) issued long-awaited guidance on post-market surveillance (PMS) under the MDR and IVDR, MDCG 2025-10 Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices. 

Background

The MDR and IVDR, respectively, strengthened the requirement for manufacturers of medical devices and IVDs to implement and maintain a PMS system within their Quality Management System (QMS). Although the components of a PMS system are clearly outlined in the regulations, MDCG 2025-10 provides examples to assist manufacturers in meeting competent authority and notified body expectations. 

As we have reported previously, PMS requirements continue to pose challenges for some manufacturers.

Interaction of the PMS system within the QMS

PMS must continue throughout the device's lifetime. The guidance includes an infographic and a more comprehensive table illustrating how the PMS system fits within the QMS. It generates critical inputs for not only the technical documents on PMS, but also other continuous QMS processes. In this respect, MDCG 2025-10 broadly aligns with our own white paper on the topic, though it explicitly excludes periodic safety updates and PMS reports from its scope. 

PMS begins pre-market

In line with the theme of PMS as a proactive and continuous information-gathering process, the guidance emphasizes that PMS planning commences during the device design and development phase. It is never too early to plan the activities for (compliance with IEC 62366) and collecting user experiences, which may later serve as real-world evidence. MDCG 2025-10 provides content examples and usage suggestions for collected data corresponding to each of the requirements under Annex III of the MDR/IVDR. 

Concluding remarks

We have also recently reported on the updated Manufacturer Incident Report (MIR) version 7.3.1. 

PMS is crucial for not only complying with EU medical device regulations, but also for the global development of ever safer and more effective devices. We have a wealth of experience in assisting manufacturers with global QMS, global device design and development, and PMS, among other areas.