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IVDs

PMS and PMPF Under IVDR: From Compliance Obligation to Continuous Performance Strategy

Thursday, May 7, 2026
16:45 - 17:45 WEST
Location: Auditorium 4
Learning Level: Advanced
Description: Under the IVDR, Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF) are no longer standalone compliance activities, they are integral to a continuous performance evaluation process that sustains CE marking and supports long-term device lifecycle management. This is particularly critical for manufacturers navigating the transition of legacy IVDs from the IVDD, as well as for those bringing novel devices to market with limited historical data.
This session will provide a practical and forward-looking exploration of how PMS and PMPF can be effectively designed, implemented, and leveraged to continuously strengthen performance evidence across the device lifecycle. The first part of the session will offer an informative overview of IVDR requirements (Annex III and Annex XIII), highlighting how PMS and PMPF feed into performance evaluation and serve as a feedback loop to update the Performance Evaluation Report. Real-world data, vigilance outcomes, and user feedback will be discussed as critical inputs for maintaining compliance and addressing evidence gaps proactively.
The second part of the session will be interactive, focusing on open discussion around the most urgent PMS and PMPF questions currently faced by the IVD industry. Drawing on perspectives from consultancy, manufacturing, and Notified Body experience, this discussion will explore common challenges observed during conformity assessments, such as weak linkages between PMS outputs and performance updates, insufficient justification of legacy data, and inconsistent PMPF strategies. Participants will be encouraged to share experiences and challenges, making this a highly practical, collaborative learning opportunity focused on real-world implementation.

Learning Objectives:

  • Understand the IVDR requirements on PMS and PMPF and learn how these tools function as core elements of continuous performance evaluation.
  • Learn how to design and operationalize PMS and PMPF processes that are compliant, efficient, and audit ready, while effectively integrating real world data, vigilance findings, and user feedback into performance evaluation and lifecycle management.
  • Identify common Notified Body findings and industry challenges related to PMS and PMPF, and gain practical insights through interactive discussion on how to strengthen performance evidence, avoid duplication of effort, and sustain market access.