Meeting the EU IVDR PMS and PMPF provisions – setting up an effective PMS/PMPF and reporting system

Description: Since May 2022, the requirements of the EU in Vitro Diagnostic Regulation (IVDR) relating to post-market surveillance, market surveillance and vigilance are applicable to all in vitro diagnostic devices, including legacy devices. The IVDR poses much more detailed requirements for Post Market Surveillance than the IVDD, and these new requirements are also partially applicable for legacy devices that still have to make the transition from IVDD to IVDR. In addition the IVDR has introduced new requirements for Post-Market Performance Follow-up (PMPF). For manufacturers it is essential to understand how to meet the new requirements for PMS and PMPF and plan for sufficient time and resources for the associated activities.

The panel will include three speakers representing IVD manufacturers, regulatory experts and notified bodies who will share their experiences with implementation of PMS and PMPF under the IVDR from their unique perspectives. This will be followed by a moderated Q&A with focus on best practices and strategies for implementation including the interfaces of the PMS and PMPF process to other processes like Performance Evaluation, Risk Management to continuously update the Technical Documentation.
Participants will be able to identify solutions to challenges relevant to the products and scenarios with which they work. This knowledge and awareness will help them build efficient strategies for PMS implementation for different types of products.