How to structure Post-Market Process within the Scope of MDR 

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The Medical Device Regulation (MDR) 2017/745 has significantly enhanced requirements for post-market surveillance (PMS) to ensure the continuous safety and performance of medical devices in the European Union. Manufacturers must establish a robust post-market process to comply with these regulations, maintain market access, and improve patient outcomes. 

The post-market surveillance system shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions. (MDR CHAPTER VII Article 83)

Key Elements of the Post-Market Process 

1. Post-Market Surveillance (PMS) Plan (MDR Article 84)

A well-defined PMS plan is the foundation of the post-market process. It must outline how data will be collected, analyzed, and used to maintain compliance and enhance product performance. The plan must include: 

  • Methods and procedures for proactive and reactive data collection 
  • Risk assessment methodologies 
  • Feedback mechanisms from users and stakeholders 
  • Processes for reporting and trend analysis 

Manufacturers of class I devices shall prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in MDR Article 84 together with a rationale and description of any preventive and corrective actions taken. The report shall be updated when necessary and made available to the competent authority upon request.MDR CHAPTER VII Article 85)

2. Post-Market Clinical Follow-up (PMCF) (MDR Part B of Annex XIV)

PMCF is a continuous process to collect real-world clinical data to confirm device performance and safety. PMCF activities must be integrated with the PMS plan and include: 

  • Systematic collection of clinical experience and literature reviews 
  • Post-market clinical studies if needed 
  • Analysis of adverse events and complaints 

3. Vigilance and Incident Reporting (MDR Article 87)

Manufacturers must report serious incidents and field safety corrective actions (FSCAs) to the relevant competent authorities within the required timelines. Key steps include: 

  • Establishing procedures for identifying and investigating incidents 
  • Timely submission of reports via the EUDAMED database 
  • Implementing corrective and preventive actions (CAPA) 

4. Periodic Safety Update Report (PSUR) (MDR Article 86) and Summary of Safety and Clinical Performance (SSCP) (MDR Article 32)

For Class IIa, IIb, and III devices, manufacturers must prepare a PSUR, summarizing PMS data, risk-benefit analysis, and conclusions on the device’s safety and performance. High-risk devices also require an SSCP, which should be made publicly available. 

5. Risk Management and Continuous Improvement  (MDR GSPR Annex I Chapter I)

PMS data must feed into the risk management process to identify new risks or changes in device performance. Manufacturers should: 

  • Regularly update risk management files 
  • Implement CAPA measures 
  • Optimize product design and labeling based on real-world evidence 

By implementing a structured and proactive post-market process, manufacturers can ensure compliance with MDR while improving patient safety and product efficacy. Keeping PMS strategies up to date is crucial for maintaining regulatory approval and fostering trust in the medical device industry. 

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