Mastering Post-market Surveillance Under IVDR: From PMPF to PSUR

Description: Although the IVDR was already published eight years ago, it still provides challenges for understanding what is expected from a manufacturer. One of these challenges is the post-market surveillance process, which will be the focus of this lecture.

With the implementation of the IVDR, new requirements for post-market surveillance have come into play, including the introduction of new terms and a new process. This lecture will explain these terms and will aid in understanding which process and related requirements need to be followed per specific device risk class. In addition, typical methods that can be used for post-market performance follow-up (PMPF) are shared, and it is explained what is expected to be present in a PMS plan and PMPF plan. The expectations of a Notified Body will be discussed for both the PMS process and PMS-related

Technical documentation, including common lessons that were learned. Finally, the interplay between the Performance Evaluation Report, the PMPF report, the Periodic Safety Update Report and the Summary of Safety and Performance will be shown, to understand this maze of reports and how they connect with each other.