AGENAS
Agenzia Nazionale per i Servizi Sanitari Regionali

Overview

The Harmonized Approach to Early Feasibility Studies for Medical Devices in the European Union (HEU-EFS) project was initiated with the aim of developing an innovative and shared program dedicated to conducting Early Feasibility Studies (EFS) in the European Union. 

EFSs are medical device clinical studies that provide relevant information on the concrete potential of the device to be introduced into clinical practice, at an early stage of device development.

EFSs promote patient access to beneficial technologies for diseases with limited or no treatment options. At the same time, medical device innovators benefit from an early view of product development, contributing to a more efficient design process.

Currently, there is no common EFS program across EU member states, which is a gap that the HEU-EFS project ambitiously attempts to fill, promoting excellence in innovation in the health system and helping to make innovations more attractive in the EU.

Funding for the project was provided by the European Commission under Call HORIZON-JU-IHI-2022-02 (Research and Innovation Actions), with a total duration of 48 months starting on the 1st October, 2023. Involving 22 public and private partners from different EU countries, the entire project has significant international relevance.

Public Partners:

Private partners: