Post-Market Clinical Follow-up in Action: A Practical Approach to EU MDR Compliance

This comprehensive webinar explores the multifaceted aspects of Post-Market Clinical Follow-up (PMCF) under the EU’s Medical Device Regulation (MDR). We’ll delve into the expectations of PMCF, strategy development and evidence gathering. We’ll also provide practical examples, consider the transferability of clinical data between regions, examine country variability within the EU and provide insights into budgetary considerations for PMCF.

Key Learning Objectives:

• Understanding PMCF Background and Strategy
  • Learn about the context of PMCF
  • Develop your strategy
  • Understand options to generate clinical evidence
• Practical Examples and Regional Differences
  • Gain insights from practical examples
    • Developing high-quality vs low-quality surveys
    • Implementation of both EU and rest of world PMCF activities to meet EU MDR requirements
• Data Transferability and Budgetary Considerations
  • Understand the considerations for transferring clinical data between regions
  • Variability of PMCF requirements within the EU
  • Get a sense of the time and cost implications of completing a PMCF study

Whether you’re a medical device manufacturer, a regulatory affairs professional, or a quality assurance specialist, this webinar will equip you with the knowledge and tools to gather the right evidence for PMCF under EU MDR.

Don’t miss this opportunity to learn from industry experts and network with peers facing similar challenges.