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 crucial part of the evidence-generation cycle for medical devices. Conducting these studies in a harmonized manner across Europe will bring significant benefits to patients, innovators, and the entire healthcare system.