HEU-EFS at RAPS Euro Convergence 2025

The HEU-EFS consortium participated in RAPS Euro Convergence 2025, held from 13–16 May at the SQUARE Brussels Meeting Centre in Brussels, Belgium. This premier event brought together regulatory professionals, industry leaders, and innovators to explore the evolving landscape of healthcare regulations and medical technologies.

As part of the conference, a poster titled “Are Early Feasibility Studies (EFS) an Orphan Approach in the Regulatory Pipeline for Innovative Medical Devices?” was presented by members of the HEU-EFS project team, including Adrián Valledor Sánchez, in collaboration with Daniel Beltran Argudo and Laura Sampietro-Colom.

The poster explored the underutilization of Early Feasibility Studies (EFS) in Europe and their potential to accelerate innovation in the medical device sector. It emphasized the need for a harmonized regulatory framework to support EFS implementation, aligning with the broader goals of the HEU-EFS project—a collaborative initiative under the Innovative Health Initiative (IHI).

Throughout the event, the HEU-EFS team represented by Fundació Clínic per a la Recerca Biomèdica, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), and Hospital Clínic de Barcelona, engaged with stakeholders across the regulatory and MedTech communities, fostering dialogue on how EFS can bridge the gap between early innovation and patient access. The discussions underscored the importance of integrating patient perspectives and real-world evidence into early-stage research and regulatory planning.

RAPS Euro Convergence 2025 served as a vital platform for the HEU-EFS consortium to share insights, gather feedback, and strengthen partnerships aimed at transforming the future of medical device development in Europe 

Tags: RAPS2025, HEUEFS, RegulatoryAffairs, MedicalDevices, EarlyFeasibilityStudies, InnovationForPatients, HealthTech