What Happens When Evidence Starts Earlier? HEU-EFS to Be Discussed at Upcoming HTAi Webinar
For innovative medical devices, generating evidence early can play an important role in guiding development, understanding initial clinical safety and performance, and supporting better-informed decisions throughout the device lifecycle. Yet across Europe, approaches to Early Feasibility Studies (EFS) remain fragmented, highlighting the need for greater coordination and harmonisation.
On 16 September 2026, the HTAi Medical Devices Interest Group (MDIG) will host a webinar exploring the role of EFS in early evidence generation and their potential implications for Health Technology Assessment (HTA).
Early evidence, better-informed decisions
The webinar, “Early Feasibility Studies for Medical Devices: HEU-EFS Progress and Implications for Early Evidence Generation and HTA,” will provide an opportunity to discuss the latest developments of the HEU-EFS project and consider how EFS can contribute to evidence generation for innovative medical devices.
EFS are limited clinical investigations conducted at an early stage of device development. They can generate important insights into a device’s initial clinical safety and performance and help inform subsequent development and design modifications.
For the HEU-EFS project, strengthening this early stage of the evidence-generation pathway is central to the development of a harmonised EU methodology for EFS. The project brings together 22 public and private partners to develop, test and validate a methodology that can support the uptake of EFS across Europe.
The webinar will explore what earlier evidence generation could mean for HTA, innovation and decision-making, as well as the opportunities and challenges associated with integrating EFS into European innovation and assessment pathways.
Meet the speakers
The session will feature:
- Laura Sampietro-Colom, Hospital Clínic de Barcelona
- Giuditta Callea, SDA Bocconi
- Andrea Rappagliosi, Edwards Lifesciences
- Adrián Valledor Sánchez, IDIBAPS
The discussion will be moderated by Richard Charter, Co-Chair of the HTAi Medical Devices Interest Group. Sasha Poulsson, WP3 Leader, will also contribute to the discussion.
📅 16 September 2026
🕒 3:00–4:00 PM GMT
Join the discussion and learn more about how the HEU-EFS project is working towards a more harmonised approach to Early Feasibility Studies in Europe.
Learn more: https://htai.org/resource/htai-webinar/