EUROPE, 20 DEC 2025 — The Medical Device Coordination Group (MDCG) has officially released MDCG 2025-10: Guidance on post-market surveillance of m edical devices and in vitro diagnostic medical devices. This long-awaited document provides the definitive interpretation of Post-Market Surveillance (PMS) requirements under Article 83 of the MDR and Article 78 of the IVDR. For manufacturers, this guidance signals a critical shift in enforcement expectations. It clarifies that PMS is not merely a regulatory reporting task but a continuous, “life-long” process designed to update technical documentation and confirm device safety in real-time. The guidance underscores that a “wait and see” approach relying primarily on reactive data like customer complaints is no longer sufficient to maintain compliance.
This article breaks down the extensive requirements detailed in the 23-page guidance and outlines the immediate impact on manufacturers placing devices on the EU market.
IMPLEMENTING PROACTIVE POST-MARKET SURVEILLANCE IN MEDICAL DEVICES
The most significant takeaway from MDCG 2025-10 is the rigid definition of “proactive” surveillance. The guidance explicitly states that manufacturers must “actively seek out” information rather than waiting for it to arrive.
Historically, many manufacturers have relied heavily on reactive sources, such as vigilance reports or spontaneous user complaints. The MDCG now clarifies that while these are necessary, they are insufficient on their own. Manufacturers must now demonstrate a systematic process to actively gather data from a wider array of sources.
Required Data Sources: According to the guidance, manufacturers must deliberately plan to gather or generate information from:
- Scientific Literature & Databases: Systematically screening technical literature and databases (like EUDAMED) for reports involving the device or similar devices.
- User Feedback Loops: Implementing tools such as customer surveys, feedback from user training workshops, and input from distributors and importers.
- Registries: Evaluating and utilizing suitable medical device registers where available.
- Similar Products: A key requirement is comparing your device’s performance against “similar products” available on the market. This benchmarking is essential to demonstrate that your device remains “State of the Art” (SOTA).
If your current PMS system does not have a documented method for actively soliciting this data, your system may be considered non-compliant.
KEY HIGHLIGHTS OF MDCG 2025-10 FOR MEDICAL DEVICE COMPLIANCE
MDCG 2025-10 reinforces that every device (or device group) must be covered by a specific PMS Plan. This is not a static document created at launch; it is a dynamic strategy that must be updated throughout the device’s lifecycle.
Key Elements of a Compliant PMS Plan:
- Defined Methods: You cannot simply list data sources; you must define the methods (qualitative or quantitative) used to analyze that data. For higher-risk devices, the guidance expects more rigorous statistical methods.
- Threshold Values: The plan must establish specific indicators and threshold values (e.g., a specific increase in side-effect frequency) that, if breached, will trigger a reassessment of the benefit-risk analysis.
- Custom-Made Devices (CMD): The guidance explicitly closes loopholes regarding Custom-Made Devices. CMD manufacturers must establish a PMS system and plan, documenting all experience gained in the post-production phase, even if they are exempt from some other technical documentation obligations.
INTEGRATING QUALITY MANAGEMENT SYSTEMS WITH POST-MARKET SURVEILLANCE
A major focus of the guidance is the interface between PMS and the broader Quality Management System (QMS). PMS cannot exist in a silo; it must act as the “heartbeat” that feeds data continuously into other processes.
The guidance (specifically Table 3) details exactly how this data flow should work:
- Risk Management: PMS data must be used to continuously reassess the probability and severity of risks. If new hazards are identified, the risk management file must be updated immediately.
- Clinical Evaluation (MDR) / Performance Evaluation (IVDR): Data from Post-Market Clinical Follow-up (PMCF) is considered “clinical data” and must be used to update the Clinical Evaluation Report (CER). This confirms the device’s safety and performance throughout its expected lifetime.
- Design & Labeling: The feedback loop must extend to the device design itself. Manufacturers are expected to use PMS insights to identify options to improve usability, performance, and safety potentially leading to updates in the Instructions For Use (IFU) or manufacturing processes.
MDCG 2025-10 : TIMELINE & LIFECYCLE OBLIGATIONS
The guidance introduces a strict “life-long” monitoring obligation. The PMS cycle begins the moment the device is placed on the market and continues until the end of the intended lifetime of the last device in use.
- Continuous Activity: Surveillance activities cannot stop simply because a marketing campaign has ended. Data collection must be systematic and recorded on a continuous basis.
- Reporting Frequency: The output of this continuous monitoring must be summarized in a PMS Report (for Class I / Class A & B devices) or a Periodic Safety Update Report (PSUR) (for Class IIa, IIb, III / Class C & D devices). These reports then drive the update of the PMS plan for the next cycle, creating a perpetual loop of improvement.
RESOURCES
- MDCG 2025-10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices.