Documentation for Post-market surveillance activities

Post-Market surveillance as per EU Regulations

An effective PMS system should be proportionate to the risk classification and complexity of the device and typically includes:

• A documented Post-Market Surveillance Plan
• Established PMS procedures for data collection, review, and analysis
• Periodic reporting activities, such as PMS Reports (PMSRs) or Periodic Safety Update Reports (PSURs), as applicable

Post-Market Surveillance System – MDCG 2025-10

A well-designed Post-Market Surveillance (PMS) system enables manufacturers to continuously monitor the safety, performance, and quality of medical devices throughout their lifecycle. The primary objective of the system is to gather, assess, and act upon post-market information to ensure that devices remain safe and effective under real-world conditions. While PMS systems may vary depending on the device and regulatory requirements, several key elements are essential for an effective program.

• Planning and Responsibility

The foundation of a successful PMS system is a documented PMS plan that defines the scope, objectives, methods, and responsibilities for surveillance activities. Organizations should assign qualified personnel, such as a quality manager or designated quality team members, to oversee the implementation and maintenance of PMS activities.

• Data Collection

Manufacturers should establish reliable mechanisms for gathering post-market information from multiple sources. These may include customer feedback, product complaints, adverse event reports, service records, literature reviews, and post-market clinical follow-up or surveillance studies. Effective data collection ensures that relevant information is captured and evaluated in a timely manner.

• Data Evaluation and Analysis

Collected data should be systematically reviewed and analysed to identify trends, emerging risks, or opportunities for improvement. Based on the findings, manufacturers may implement corrective or preventive actions, update product labeling or instructions for use, conduct additional investigations, or, when necessary, initiate field actions such as product recalls.

• Training and Awareness

Personnel involved in PMS activities should receive appropriate training on surveillance procedures, complaint handling, data analysis, and reporting requirements. Adequate training helps ensure that valuable feedback is properly captured, communicated, and addressed.

• Risk Management Integration

PMS should be closely linked to the risk management process. Information obtained through post-market activities should be used to reassess existing risks, identify new hazards, and implement measures to maintain an acceptable benefit-risk profile. Actions may include risk control updates, process improvements, or Field Safety Corrective Actions (FSCAs) when required.

PMS Data Collection Activities

• Serious Incident Monitoring
• Non-Serious Incident Monitoring
• Undesirable Side Effects Monitoring
• Trend Reporting
• Customer and User Feedback
• Complaint Handling
• Returned Product Analysis
• Literature Review
• Corrective and Preventive Action (CAPA) Review
• Real-World Evidence (RWE) / Post-Market Clinical Follow-Up (PMCF)
• Post-Market Surveillance Plan (PMS Plan): The PMS Plan specifies the methods and procedures for systematically collecting and evaluating post-market information from relevant sources, including:
• Serious incidents and Field Safety Corrective Actions (FSCAs).
• Customer complaints and user feedback.
• Relevant databases, registries, and published literature.
• Device performance data and other relevant post-market information.

The plan should define data collection procedures, analytical methods, risk assessment approaches, complaint investigation and trend reporting processes, communication with Competent Authorities and Notified Bodies, and device traceability mechanisms.

• Post-Market Surveillance Report (PMS Report): Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), manufacturers of Class I medical devices and Class A and B IVDs are required to prepare a Post Market Surveillance Report (PMSR). Report summarizes the findings and conclusions derived from the post-market surveillance activities conducted in accordance with the established PMS Plan. PMSR must be maintained and periodically updated. The report provides a comprehensive analysis of the collected PMS data, including an evaluation of device safety and performance throughout its lifecycle. It also documents customer complaints, identified trends, and any corrective or preventive actions implemented. In addition, the PMSR include information on the number of devices placed on the market, sales data where applicable, and details of any observed nonconformities. The PMSR must be reviewed and updated at regular intervals, as well as whenever significant changes are made to the device or its intended use. By continuously monitoring real-world performance and safety, the PMSR serves as an important tool for demonstrating regulatory compliance and supporting the ongoing benefit-risk evaluation of medical devices and IVDs throughout their lifecycle.
• Periodic Safety Update Report (PSUR): MDCG 2022-21

Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), manufacturers are required to establish post-market surveillance documentation appropriate to the device classification. Manufacturers of higher-risk devices must prepare a Periodic Safety Update Report (PSUR).

The PSUR is mandatory for Class IIa, Class IIb, and Class III medical devices, as well as Class C and Class D IVDs.

The report provides a comprehensive summary of the results and conclusions obtained from post-market surveillance activities conducted in accordance with the PMS Plan. It also includes an assessment of the device's benefit-risk profile, sales and usage data (where available), and a detailed description of any corrective or preventive actions implemented in response to identified issues. The PSUR forms part of the device’s technical documentation and is required for all applicable device classes, except custom-made devices.

The PSUR must be maintained and regularly updated throughout the device lifecycle to ensure continued monitoring of safety and performance.

• Class IIb and Class III medical devices, as well as Class C and Class D IVDs, must have their PSUR updated at least once every year.
• Class IIa medical devices must update the PSUR whenever necessary and at a minimum every two years.