Novel Approaches for PMPF Surveys Under IVDR – Industry and Notified Body Perspectives

Description: With new regulation comes new requirements, and three years into enforcement of the IVDR, there are still questions around Post-Market Performance Follow-up (PMPF). While not all IVDs placed on the market require specific PMPF activities, there are cases when additional evidence is needed to support continued safety and performance even after an IVD has its CE-mark. The conservative path would be to undertake a robust Clinical Performance Study, which can require significant resources to execute. However, the cost and time burden of that effort may not be needed.

Post-market clinical follow-up (PMCF) surveys have been a valuable and widely used method for collecting post-market clinical data under MDR, but the use of equivalent PMPF surveys for IVDs has not been as widely adopted. This is likely due to challenges in finding a simple use case for PMPF under IVDR, and limited understanding of how to create a survey that will provide clear, actionable clinical performance information for an IVD.

In this session, we will explain the principles of PMPF survey design and execution while exploring specific use cases for PMPF surveys under IVDR. The types of products and clinical performance gaps that are most amenable to a survey-based PMPF activity will be addressed. Case studies will be presented with industry perspective on strategic considerations. The notified body will provide insight and feedback on regulatory considerations and concerns for PMPF survey design.