12 Tips for Effective Post-Market Surveillance Under EU-MDR

In this blog, we have provided tips to perform effective post-market surveillance under EU-MDR.

What is post-market surveillance under EU-MDR?

Post-market surveillance under EU-MDR is the structured process by which manufacturers continuously monitor the safety, performance, and quality of their devices once they are placed in the EU market. It is a proactive, systematic requirement and not just a reactive one. PMS under EU-MDR is a continuous lifecycle oversight. PMS objectives are clearly defined to ensure that medical devices remain safe, effective, and compliant throughout their lifecycle. Manufacturers must actively learn from real-world device use and feed that intelligence back into risk management, clinical evaluation, and regulatory compliance.

7 key objectives of EU-MDR post-market surveillance

1. Ensure ongoing safety and performance: Continuously verify that devices perform as intended and remain safe when used in real-world conditions.
2. Identify and mitigate risks early: Detect new or emerging risks, trends, or adverse events, and implement corrective or preventive actions before they escalate.
3. Maintain regulatory compliance: Demonstrate ongoing conformity with the General Safety and Performance Requirements (GSPRs) outlined in Annex I of EU-MDR.
4. Support clinical evaluation updates: Provide real-world evidence that feeds into the Clinical Evaluation Report (CER), ensuring benefit-risk assessments remain valid.
5. Enable transparency and traceability: Supply data to EU electronic systems (EUDAMED) for vigilance and market surveillance, supporting regulators and stakeholders.
6. Drive continuous improvement: Use PMS findings to refine design, manufacturing, labeling, and instructions for use, ensuring devices evolve with user needs and regulatory expectations.
7. Strengthen patient and user protection: Safeguard public health by ensuring that any serious incidents or field safety corrective actions are detected, reported, and acted upon promptly.

7 Key elements of post-market surveillance under EU-MDR

1. PMS system: Manufacturers must establish, document, implement, and maintain a PMS system. The EU-MDR post-market surveillance system must be proportionate to the risk class and type of device. It should actively and systematically gather, record, and analyze data on device performance and safety. The PMS system must be integrated into the manufacturer’s Quality Management System (QMS).
2. PMS plan: Each device requires a PMS plan that defines data sources (complaints, user feedback, registries, literature, vigilance reports), methods for data collection and analysis, criteria for risk reassessment and corrective actions. Additionally, it should detail how PMS findings will update the risk management file, clinical evaluation, and benefit-risk assessment. The plan must be device-specific and proportionate to its risk class.
3. PMS report: Post-market surveillance under EU-MDR requires PMS report for Class I devices. A summary report containing results and conclusions from PMS data and description of corrective and preventive actions taken must be prepared. This report must be made available to competent authorities upon request.
4. Periodic safety update report (PSUR): Post-market surveillance under EU-MDR requires periodic safety update report for Class IIa, IIb, and III devices. It must be updated at least every 2 years for Class IIa and annually for Class IIb and III. The PSUR should include conclusions from PMS data, description of corrective/preventive actions, updated benefit-risk determination, volume of sales, population exposed, and usage frequency. The PSUR must be submitted to the Notified Body and uploaded to EUDAMED.
5. Integration with vigilance: PMS is closely linked to vigilance requirements. Serious incidents and field safety corrective actions (FSCA) have to be reported. Trend should be reported for non-serious incidents if they show significant increase. PMS data feeds into vigilance systems to ensure timely regulatory oversight.
6. Market surveillance: Competent authorities use PMS and vigilance data for market surveillance. This ensures manufacturers comply with EU-MDR and that unsafe devices are withdrawn or corrected.
7. Lifecycle feedback loop: PMS findings must feed back into risk management (ISO 14971 alignment), clinical evaluation (Annex XIV), design and manufacturing improvements, and labeling and instructions for use (IFU) updates. This creates a continuous improvement cycle ensuring devices remain safe and effective throughout their lifecycle.

Therefore, post-market surveillance under EU-MDR is a proactive, structured, and mandatory system. It ensures continuous monitoring, reporting, and improvement of medical devices after they reach the market.

PMS data collection under EU MDR

EU MDR post market surveillance data collection is a structured and proactive process. The regulation requires manufacturers to actively and systematically gather information from multiple sources to monitor device performance and safety once the product is launched in the market.

Key sources of post market surveillance data

• Complaints and customer feedback: Direct reports from users, healthcare professionals, patients, service records, and distributor feedback.
• Vigilance system: Serious incident reports, Field Safety Corrective Actions (FSCA), and trend reports for non-serious incidents showing significant increases.
• Registries and databases: National or EU-level patient/device registries, EUDAMED entries, and vigilance reports.
• Scientific literature and clinical data: Published studies, case reports, reviews, and ongoing or post-market clinical follow-up (PMCF) studies.
• Internal data: Manufacturing and quality control records, supplier audits, and nonconformance reports.
• Market feedback: Sales volume, geographic distribution, user demographics, training, and usability feedback from healthcare providers.

Methods of EU MDR post market surveillance data collection

• Active collection: Surveys, questionnaires, PMCF studies, and targeted follow-ups with users are active data collection methods for post-market surveillance under EU-MDR.
• Passive collection: Complaints, spontaneous feedback, and literature monitoring are passive collection method
• Systematic analysis: Trend analysis, statistical evaluation, and signal detection are part of systematic analysis.

Integration of PMS data

• Technical documentation: PMS findings must be documented and retained.
• Regulatory reporting: PMS data is recorded in PMS Reports (Class I) or PSURs (Class IIa, IIb, III) as applicable.

EU-MDR emphasizes that post market surveillance data collection must be continuous, proactive, and proportionate to device risk class. It is not enough to wait for complaints. Manufacturers must actively seek and record data to ensure ongoing compliance and patient safety.

Tips for post-market surveillance under EU-MDR

We have provided some pro tips to help perform effective post-market surveillance under EU-MDR.

Strategic tips

• Embed PMS into your QMS: Treat PMS as a living system within your Quality Management System (QMS) and not a standalone activity. This ensures consistency and traceability.
• Risk-based approach: Scale your PMS activities according to device risk class. Higher-risk devices (Class IIb/III) require more intensive monitoring and reporting.
• Proactive data collection: Do not rely only on complaints. Actively gather data from registries, literature, user surveys, and Post-Market Clinical Follow-up (PMCF).

Operational tips

• Define clear PMS plans: Document sources, methods, and thresholds for corrective actions. Regulators expect structured, device-specific plans.
• Maintain strong vigilance links: Ensure PMS data flows seamlessly into vigilance reporting (serious incidents and trend reports). This integration is critical for compliance.
• Regular reporting: Class I medical device requires PMS report (to be made available upon request). Class IIa medical device requires PSUR every 2 years. Class IIb/III medical device requires PSUR annually. Have templates ready for consistency in reporting.

Integration tips

• Feed PMS findings into risk management: Update hazard analyses and benefit-risk assessments continuously.
• Update clinical evaluation reports (CER): Use PMS data as real-world evidence to strengthen or adjust clinical claims.
• Close the feedback loop: Ensure PMS findings lead to design improvements, labeling updates, or IFU refinements.

Documentation tips

• Keep records audit-ready: Retain PMS documentation for 10–15 years depending on device type. Ensure accessibility for regulators and Notified Bodies.
• Use dashboards and trend analysis: Visualize PMS data for easier interpretation and faster decision-making during audits.
• Standardize templates Develop SOPs and checklists for PMS Plans, PMS Reports, and PSURs to streamline compliance.

Therefore, post-market surveillance under EU-MDR is all about continuous vigilance and improvement. We at Pharmadocx Consultants will help you easily comply with all EU MDR requirements. Additionally, we provide comprehensive CE marking service. Email at [email protected] or call/Whatsapp on 9996859227 to hire our experts.