Background
The Medical Device Coordination Group (MDCG) published MDCG 2025-10, Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices. The document consolidates practical guidance on implementing the post-market surveillance (PMS) system required by the medical devices and IVD medical devices regulations, MDR and IVDR, (art. 10, art. 83 MDR / art. 78 IVDR). It reiterates that PMS is a continuous, risk-proportionate process embedded in the QMS and intended to feed clinical/performance evaluation, risk management and technical documentation throughout a device’s lifetime.
Past discussions showed that there is much uncertainty as to which level of detail and attention associated documents like the PMS plan need to provide. Under the MDR and IVDR, the PMS plan along with the PMS report or Periodic Safety Update Report (PSUR) is part of the technical documentation. It is hoped that MDCG 2025-10 will provide more clarity and consistency.
Main points
• PMS plan: The PMS plan is part of the technical documentation and must set objectives, data sources, methods, responsibilities, timelines and resources proportionate to device risk. Table 1 of the guidance provides an explanation and examples for the requires elements as per annex III of the MDR and IVDR.
• Data sources & collection: Guidance lists primary sources (vigilance, registry data, published literature, complaints, user feedback, EUDAMED, device registries) and describes active vs passive collection methods and sample-size/period considerations. Table 2 again provides examples and the use of the corresponding information.
• Assessment & analysis: Manufacturers must define statistical approaches, baselines and thresholds for signals and “statistical significance”, and document how data are analysed to identify trends and emerging risks. It is also essential to determine if the device still performs in accordance to similar devices and the state of the art and to confirm the acceptability of the benefit-risk ratio.
• Actions & reporting: PMS conclusions must trigger updates to technical documentation, clinical/performance evaluations, risk management, corrective and preventive actions, vigilance actions where needed, and feed into PMS reports / PSURs as applicable.
• Integration with QMS: The document details interfaces between PMS and other sections of the QMS, e.g. clinical evaluation and risk management. The guidance includes a details Table 3 to outline the interconnections.
Key takeaways
- Manufacturers must be proactive and evidence-driven: PMS is continuous — not a periodic checkbox — and must demonstrably inform benefit–risk decisions.
- Document methods up front: Pre-specified statistical methods, baselines and rationale reduce regulatory friction when trends arise.
- Link PMS to the whole QMS: Ensure traceability from data → analysis → decision → technical-documentation update.
- Use the Tables and Annexes: Tables 1 to 3 as well as Annex 1 and Annex 2 are actionable aids for preparing submissions and demonstrating compliance.
MDCG 2025-10 is an essential practical reference to tighten post-market evidence loops and demonstrate that real-world data meaningfully underpin device safety and performance.
Source: MDCG
