MDCG 2025–10 is the first comprehensive EU guidance that frames PMS as a structured, continuous system applicable to both MD and IVD. The document strengthens the role of PMS as a key data source for clinical/performance evaluation, risk management, and the design of post-market clinical and performance follow-up activities (PMCF/PMPF) as well as post-market studies.

MDCG 2025–10 – “Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices” published on 19 December 2025, provides a practical framework for manufacturers on how to design and operate a PMS system in line with MDR (2017/745) and IVDR (2017/746), in a structured, proactive and risk-proportionate manner. It should be noted that this is a guidance document developed by the Medical Device Coordination Group (MDCG), not legally binding act of the European Commission (EC). Nevertheless, it represents a key reference point for the expectations across competent authorities and notified bodies.

Was there similar guidance previously available on the Commission website?

The “MDCG endorsed documents…” page already contained a Post-Market Surveillance and Vigilance (PMSV) section, but it mainly included topic-specific guidance (e.g. Periodic Safety Update Report – PSUR guidance, MDCG 2022-21, vigilance Q&As and Device-Specific Vigilance Guidance (DSVG) templates. MDCG 2025–10 is the first comprehensive, system-level PMS guidance, covering both MDs and IVDs.

Scope of MDCG 2025–10 and key principles

The guidance defines four core elements: it describes (1) the PMS system, (2) the PMS plan, (3) the main PMS activities, and (4) how PMS interacts with other key quality management system (QMS) processes. It is generally applicable to all MDs and IVDs, with explicit exclusions (e.g., it does not provide detailed instructions on PSUR drafting and does not further elaborate requirements for in-house devices).

The key message is clear: PMS is a continuous process that involves the systematic collection and analysis of post-market data, and its outputs should form the basis for: updates to technical documentation, risk management activities, implementation of corrective and preventive actions (CAPA).

 Impact on clinical investigations (PMCF/PMPF and post-market studies)

MDCG 2025–10 positions PMS as an integral part of the QMS that directly feeds clinical/performance evaluation and risk management. In practice, this has clear implications for clinical teams and CROs:

  • PMS data will more often initiate, justify, or reshape PMCF/PMPF activities and post-market clinical investigations,
  • PMS plans will increasingly need to align with predefined PMS data sources (registries, literature surveillance, user feedback, observational data, trend analysis),
  • documentation consistency becomes critical – study protocols/plans, PMS plans, risk analyses and reporting must be logically aligned.

The guidance also addresses custom-made devices (CMD). PMS obligations apply to CMDs, and the document indicates that a PMCF plan is generally required, as post-market review focuses on confirming expected performance and/or clinical benefit.

 Key highlights

  • PMS plan as the backbone of the system – a clear description of scope, methods, data sources, analysis frequency, and decision criteria is expected.
  • Proactive data sources – beyond complaints and incidents, PMS should also include literature, registries, servicing data, user training feedback and stakeholder input.
  • Distinction between PMS Report and PSUR – depending on device class under MDR/IVDR and update cycles defined in the PMS plan.
  • Management oversight – PMS effectiveness should be escalated to top management (e.g., as part of management review).
  • Implementation-oriented annexes – Annex 1 (overview of PMS obligations under MDR/IVDR) and Annex 2 (scenarios illustrating how PMS updates other processes).

Conclusion

MDCG 2025–10 clarifies expectations for PMS, shifting the focus from a reactive “complaint-driven” approach to a system that actively generates and uses data throughout the entire device lifecycle, including through PMCF/PMPF activities and post-market studies. For clinical teams, this translates into more projects where clinical investigations are embedded within a closed loop of PMS ↔ clinical/performance evaluation ↔ risk management ↔ CAPA, rather than functioning as standalone documentation artefacts.

 

Link to the MDCG 2025-10 document:https://health.ec.europa.eu/document/download/a9ad86b7-1b8e-4bae-beb4-48b2b3ed2f05_en?filename=mdcg_2025-10_en.pdf