EU Publishes MDCG Guidance on Post-Market Surveillance

As of December 2025, The Medical Device Coordination Group (MDCG) has published MDCG 2025-10, providing comprehensive guidance on post-market surveillance (PMS) systems for medical devices regulated under Regulation (EU) 2017/745 (MDR) and in vitro diagnostic medical devices regulated under Regulation (EU) 2017/746 (IVDR). 

MDCG Post-Market Surveillance Guidance and Plan Requirements

This guidance addresses the manufacturer’s obligations under MDR Article 83 / IVDR Article 78 (post-market surveillance system) and MDR Article 84 / IVDR Article 79 (PMS plan). It applies to all device risk classes and covers the complete device lifecycle from initial market placement through to discontinuation. 

Document Structure 

The new guidance outlines: 

• Objectives and underlying principles of PMS under MDR/IVDR 

• Expected content and operational requirements for PMS systems and plans 

• Interfaces between PMS and related regulatory processes 

• Practical implementation support through annexes and worked examples 

Key Provisions 

1. PMS as a Continuous, Proactive Process 

The guidance reinforces that PMS under the EU MDR/IVDR represents a fundamental shift from the reactive approach under the Medical Device Directives. Under the regulations, manufacturers must now: 

• Actively and systematically collect post-market data throughout the device lifecycle, not merely in response to complaints or incidents; 

• Use PMS data to continuously confirm safety, performance, and benefit-risk acceptability against evolving state of the art; and 

• Implement early detection mechanisms for emerging risks, changes in known risk profiles, trends in misuse, or off-label use patterns. 

Importantly, the guidance emphasizes that complaint handling and vigilance reporting alone do not constitute an adequate PMS system. Activities must be risk-proportionate, device-specific, and appropriately documented. 

2. Integration with Quality Management System 

MDCG 2025-10 clarifies that the PMS system cannot operate in isolation. It must be: 

• Fully embedded within the manufacturer’s ISO 13485-compliant quality management system 

• Linked bidirectionally to core processes including:  

• Risk management (ISO 14971) 

• Clinical evaluation (MDR) / performance evaluation (IVDR) 

• Vigilance reporting and FSCA decision-making 

• Corrective and preventive action (CAPA) 

• Technical documentation maintenance and updates 

• Design and development processes 

The guidance stresses that PMS outputs should feed multiple regulatory and quality activities simultaneously rather than existing as isolated deliverables. 

3. PMS Plan: Required Content and Specificity 

The document provides detailed clarification on PMS plan content, including: 

Data sources to be identified and justified: 

• Complaints and user feedback (including structured surveys) 

• Vigilance reports and trend reporting data 

• Post-market clinical follow-up (PMCF) or post-market performance follow-up (PMPF) activities 

• Scientific and medical literature 

• Registries, real-world data, and electronic health records where applicable 

• Competent authority databases and publicly available safety information 

Methodological Requirements: 

• Documented methods and defined frequency for data collection 

• Analytical approaches for data evaluation 

• Clear criteria for signal detection and trend identification 

• Escalation thresholds triggering vigilance reporting or FSCA consideration 

• Assigned roles, responsibilities, and competency requirements 

The guidance reinforces that PMS plans must be device-specific, and that generic, template-driven approaches are insufficient. Where certain data sources or activities are not applicable, manufacturers must provide documented justification. 

4. Data Analysis and Application of PMS Outputs 

MDCG 2025-10 places substantial emphasis on the analytical phase, clarifying that manufacturers should: 

• Apply systematic, documented, and reproducible methods to analyze collected data 

• Assess data both individually (for signal detection) and cumulatively (for trend identification) 

• Use PMS findings to inform:  

• Risk management file updates, including residual risk re-evaluation 

• Clinical/performance evaluation updates and conclusions 

• Revisions to instructions for use, labelling, or device design 

• CAPA initiation or FSCA implementation, where warranted 

• State of the art assessments and benefit-risk determinations 

The guidance clarifies that trend analysis, rather than focus on isolated events, should drive decision-making—aligning with MDR Article 88 / IVDR Article 83 trending obligations. 

5. Interface with Vigilance and FSCA 

The document addresses the relationship between PMS and vigilance, noting that: 

• PMS is broader in scope than vigilance and encompasses non-reportable incidents, near-misses, performance feedback, and use-related concerns. 

• Vigilance reporting obligations remain subject to MDR/IVDR-defined timelines, thresholds, and reporting criteria (as further clarified in MDCG 2023-3). 

• PMS analysis should enable proactive identification of situations requiring vigilance notification or FSCA implementation, supporting timely regulatory action. 

This clarification aims to support consistent, evidence-based decision-making and help manufacturers avoid both under-reporting and over-reporting. 

6. Annexes and Practical Implementation Support 

The annexes to MDCG 2025-10 include: 

• A consolidated overview of PMS-related obligations across MDR and IVDR 

• Illustrative examples demonstrating how PMS activities feed into risk management updates, clinical/performance evaluation reports, and technical documentation revisions 

• Flowcharts or decision trees for common PMS scenarios (if included) 

These practical resources are intended to support manufacturers, particularly those transitioning legacy devices in aligning existing PMS systems with MDR/IVDR expectations. 

Practical Implications for Manufacturers:

• Gap analysis: Manufacturers should assess current PMS systems against this guidance to identify compliance gaps. 

• Documentation review: PMS plans may require updates to reflect the enhanced specificity and justification requirements. 

• Process integration: Consider whether PMS outputs are appropriately feeding risk management, clinical evaluation, and CAPA processes. 

• Resource planning: The emphasis on proactive, continuous surveillance may require additional resources or competencies. 

• Notified body expectations: This guidance will likely inform Notified Body assessments of PMS system adequacy during conformity assessment. 

Related MDCG Post-Market Surveillance Guidance 

This document should be read in conjunction with: 

• MDCG 2020-7: PMCF Plan Template 

• MDCG 2020-8: PMCF Evaluation Report Template 

• MDCG 2022-21: Guidance on Periodic Safety Update Report (PSUR) 

• MDCG 2023-3 Rev.2: Q&A on Vigilance Terms and Concepts 

• ISO/TR 20416:2020: Post-market surveillance for manufacturers 

How MedEnvoy Can Support 

MedEnvoy can support manufacturers and other economic operators with practical implementation of their PMS system and PMS plan reviews, gap assessments, updates to PMS documentation and QMS procedures, and audit readiness support for Notified Body assessments and competent authority inspections. To learn more about our EU Authorized Representative services, click here.

If you have any questions regarding this summary or the accompanying guidance document, we encourage you to contact our team for tailored support.