Breakout #1: International: Experience and Challenges With MDR/IVDR and EUDAMED

This session will provide insight into the latest developments in implementing The European MDR and IVDR, 8 years after publication. A lot is clear, and many are fully in compliance or making progress. Despite the progress and further clarity on expectations, still over 50% of all products need to be evaluated under the current regulatory regime. The session will analyze the current situation, with emphasis on new elements such as the notified bodies structured dialogue, the European Medicines Agency’s expert panel advice and initial attempts on new supporting initiatives in scientific advice, the renewed interest of the EU on innovation, as well as support to SME’s and to orphan devices. It will also focus on the state of play of EUDAMED, finally getting into a central registration instead of a country-by-country system that is very scattered in approach. And lastly, the panel will address the ongoing discussions on further reform of the governance system, as well as some of the more immediate actions ongoing to improve the functioning of the EU legislative system. Some practical cases will feature in the discussions.