HARMONISED APPROACH TO EARLY FEASIBILITY STUDIES FOR MEDICAL DEVICES IN THE EUROPEAN UNION

Welcome

HEU-EFS is a European Public-Private Partnership with the aim to develop an EU harmonized framework to improve the uptake of Early Feasibility Studies (EFS) for medical devices in the European Union.

EFS are a critical step in evidence generation cycle for medical devices. Ensuring that they can be conducted in a harmonised manner in Europe will carry significant benefits for patients, innovators, and the entire healthcare system.