HEU-EFS at ISPOR Europe 2026: Join Our Panel on Early Feasibility Studies in Europe
The HEU-EFS project will host a panel session at ISPOR Europe 2026, the leading European conference for health economics and outcomes research (HEOR), taking place from 8 to 11 November at the Austria Center Vienna.
Join our panel session: From Framework to Practice: Piloting a Harmonized EU Approach to Early Feasibility Studies to Shape the Future Medical Device Regulatory Framework
Why Early Feasibility Studies matter now
Early Feasibility Studies (EFS) allow innovators to test certain medical devices in a small number of patients early in development, making them a critical step in the clinical evidence pathway. Yet gaps in the EU regulatory framework make EFS less structured and predictable in Europe than elsewhere. With the Medical Device Regulation (MDR) now under review, there is a timely opportunity to change this.
What the session will cover
The panel will present the harmonised EFS framework developed by HEU-EFS, showing where it aligns with current regulation and where improvements are needed. Speakers will also introduce the pilot phase now testing the framework in real-world settings.
Meet the speakers
- Giuditta Callea, PhD (moderator), SDA Bocconi School of Management
- Alexandra Poulsson, Norwegian Institute of Public Health
- Marta Bragagnolo, Global Heart Hub
- Fanny van der Loo, Edwards Lifesciences
Who should attend
The session is for regulators, notified bodies, HTA bodies, patient organisations, policy-makers, ethics experts, clinical investigators and medical device manufacturers who want to help shape the future of EFS in the EU.