EU MDCG 2025-10 Guidance on Post-Market Surveillance (2025)
The EU MDCG 2025-10 Guidance on Post-Market Surveillance of Medical Devices and In Vitro Diagnostic Medical Devices (Dec 2025) provides manufacturers with detailed, non-binding guidance on applying MDR and IVDR PMS requirements and integrating PMS into the Quality Management System (QMS). It supports proactive monitoring of device safety and performance throughout the device lifecycle.
The European Commission’s Medical Device Coordination Group (MDCG) issued MDCG 2025-10: Guidance on Post-Market Surveillance (PMS) on 19 December 2025. This non-binding guidance explains the MDCG’s recommended approach to the PMS requirements under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). It does not replace the Regulations or a binding interpretation of Union law.
Rather than treating PMS as a series of regulatory checkboxes, the guidance emphasizes a proactive, continuous monitoring approach that ties directly into key quality and risk processes.
Key Components of the MDCG 2025-10 PMS Guidance
PMS System Requirements
MDCG 2025-10 clarifies that a PMS system must systematically and continuously collect, analyze, and act on real-world experience with a device or device group. This includes:
Pre-planned methods for gathering data (not just reactive sources)
Defined qualitative and quantitative analysis approaches
Integration with vigilance and risk management processes.
PMS Plan Expectations
Each device must be covered by a PMS Plan. One plan may cover a justified, clearly identified group of devices. The plan:
Describes methods and data sources
Defines threshold values for performance indicators
Sets out actions if trends or risks change
Is regularly updated throughout the device lifecycle
PMS Reporting and Lifecycle Monitoring
The guidance supports established regulatory outputs such as:
Post-Market Surveillance Reports (for MDR Class I and IVDR Class A and B devices)
Periodic Safety Update Reports (PSURs) (for the other MDR and IVDR classes)
These reports must feed back into the PMS cycle, driving continuous improvement and updates to technical documentation and risk files.
Integrating PMS Into the Quality Management System
A significant focus of MDCG 2025-10 is the integration of PMS with the manufacturer’s QMS, confirming that PMS should not be isolated but embedded in existing processes:
Risk Management: PMS data must inform the ISO 14971 risk-management process, including probability and severity assessments
Clinical/Performance Evaluation: Ongoing data must update clinical or performance evaluations
Design & Labeling: Insights from PMS should inform design improvements and IFU updates where needed.
This close linkage ensures PMS drives proactive improvements rather than delayed corrective actions.
Why Manufacturers Should Care
MDCG 2025-10 is a practical, non-binding reference for manufacturers building MDR/IVDR post-market systems. It:
Expands on Articles 83 (MDR) and 78 (IVDR) for PMS interpretation
Encourages proactive data collection beyond complaint logs
Reduces regulatory risk through stronger, lifecycle-focused surveillance
Manufacturers should also connect reportable field action to the FSCA definition and responsibilities. Adapting PMS processes early can enhance safety, reduce non-conformance findings, and support smoother audits and regulatory reviews.
Immediate Compliance Actions
Manufacturers and QMS leads should:
Review current PMS systems against MDCG 2025-10 expectations
Update PMS Plans to include proactive data sources
Ensure linkage between PMS, risk management, and clinical/performance evaluation
Document thresholds and decision criteria for risk changes
These actions help align PMS processes with MDR/IVDR requirements and current MDCG best practice.
External Links
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