MDCG 2025-10: Strengthened expectations for PMS systems under MDR and IVDR
In December 2025, the Medical Device Coordination Group (MDCG) published a new guidance document — MDCG 2025-10 — clarifying expectations around post-market surveillance (PMS) for both medical devices and IVDs.
The document doesn’t introduce new obligations, but it does sharpen the focus on how PMS must be structured, documented, and integrated into the manufacturer’s quality management system. For many, this will require a rethink of how PMS plans are built and used in practice.
A more operational view of PMS
The guidance reinforces that PMS is not just about vigilance or complaint handling. It must be:
Proactive — relying on planned, structured data gathering, not just reactive inputs.
Continuous — extending across the full intended lifetime of the device.
Integrated — feeding into risk management, clinical evaluation, and other core QMS processes.
It also confirms that every device (or defined group of devices) must be covered by a PMS plan, and that this plan should define how data is collected, analysed, and used to drive action.
What changes for manufacturers?
While the legal framework hasn’t changed, MDCG 2025-10 makes it clear that PMS is a living system, not a document to archive. Manufacturers should expect more detailed scrutiny on:
How they define “proactive” data sources.
The link between PMS data and risk management updates.
Justifications for why certain PMS or PMCF activities are not performed.
The completeness and clarity of PMS plans and related procedures.
For custom-made devices, the guidance also confirms that PMS is still required, even if the PMS plan isn’t part of the technical documentation.
Why this matters
With increased attention from notified bodies and competent authorities on PMS and lifecycle evidence, this guidance serves as a practical benchmark for what compliance should look like in 2026 and beyond.
Read the full guidance below.
