Session (CTI)

ISSUE: The Medical Device Regulation (MDR) has raised evidence standards for regulatory approval in the EU, likely increasing the need for clinical trials to support CE marking. Traditional feasibility or pivotal trials often fail due to unforeseen issues in device design or implantation, leading to patient harm and higher development costs. Early Feasibility Studies (EFS), conducted at an early development stage, help assess initial safety and performance—especially when further non-clinical testing is limited—and support device refinement before larger trials. In the U.S., the FDA launched its EFS Program to streamline development, accelerate market access, and strengthen early-stage innovation. Whether Europe should implement a similar programme remains under discussion. This session will explore the potential value of a European EFS programme, aligned with MDR, and how it could improve regulatory and HTA processes. Key topics include the potential of EFS to enhance device safety, inform pivotal trial design, and support a life-cycle approach to evaluation. OVERVIEW: An overview will be provided by Mr. Andrea Rappagliosi (Edwards Lifesciences, HEU-EFS private consortium coordinator) during the first 5 minutes. Each panelist will then share their perspective on the challenges of current clinical investigations in Europe and present recommendations from the HEU-EFS project in 15 minutes. In the last 10 minutes, Prof. Carlo Federici (SDA Bocconi School of Management, HEU-EFS leader) will collect questions from the audience to be discussed with panelists in a roundtable. Regulators, HTA agencies, notified bodies, patients associations, ethical and legal experts, the industry will particularly benefit from attending.