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 interpretations of MDR and IVDR PMS requirements and explains how to integrate PMS into the Quality Management System (QMS). This practical guidance helps manufacturers proactively monitor device safety and performance throughout the device lifecycle, creating stronger and more compliant PMS systems.
The European Commission’s Medical Device Coordination Group (MDCG) issued MDCG 2025-10: Guidance on Post-Market Surveillance (PMS) on 19 December 2025. This guidance interprets the PMS requirements under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) and offers manufacturers a roadmap to build compliance-ready and lifecycle-oriented PMS systems.
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 (or device group) must have a PMS Plan that:
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 lower-risk devices)
Periodic Safety Update Reports (PSURs) (for higher-risk devices)
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 risk 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 an essential reference for manufacturers aiming to meet MDR/IVDR post-market obligations comprehensively. 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
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 companies with EU enforcement expectations and regulatory best practice.
External Links
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