Session (CTI)

ISSUE The MDR is currently being reviewed, creating a timely opportunity to address gaps in the EU regulatory framework that are preventing the uptake of EFS in Europe, which are a critical step in the clinical evidence pathway for certain devices. This session will explore the harmonized framework for EFS developed by the HEU-EFS project, highlighting both areas of alignment with current regulatory landscape and recommendations for future improvements. Attention will be given to how the framework could bring a more structured, predictable, and harmonized approach to EFS across EU. The panel will also discuss the pilot phase currently underway to test the framework in real-world settings, with the aim of generating practical recommendations and support future policy and regulatory developments. OVERVIEW An overview of the harmonised HEU-EFS framework will be provided by Prof. Giuditta Callea (SDA Bocconi, HEU-EFS Coordinator) (10 minutes). Dr. Alexandra Poulsson (NIPH) will describe the opportunities offered by the HEU-EFS framework to address key challenges within the current EU regulatory landscape for MDs (10 minutes). Mr. Andrea Rappagliosi (Edwards Lifesciences) will then present the objectives and expected outcomes of the HEU-EFS pilot phase, focusing on the results of the open call for pilots launched by the project and the work conducted by the HEU-EFS Screening Committee in selecting candidate pilots (10 minutes). Ms. Marta Bragagnolo (GHH) will present key elements of the HEU-EFS Roadmap for structured patient involvement in EFS. The final 20 minutes will be dedicated to an interactive discussion with the audience, moderated by Prof. Callea. Questions and comments from participants will be discussed in a roundtable format with panellists. This session will be of particular interest to regulators, HTA bodies, notified bodies, patient organizations, decision-makers, ethics experts, clinical investigators, and medical device manufacturers seeking to contribute to the future development of EFS in EU.