Études de faisabilité précoce en Europe : enjeux, perspectives et impacts attendus pour l’évaluation clinique des dispositifs médicaux (Early feasibility studies in Europe: Challenges, perspectives, and expected impacts on the clinical evaluation of medical devices)

The European Regulation (EU) 2017/745 on medical devices (MDs) strengthened clinical evaluation requirements and made clinical investigations mandatory for high-risk devices. Among these, Early Feasibility Studies (EFS), as defined by ISO 14155:2020, are pre-market clinical investigations designed to collect preliminary data on a device's safety and performance before its final version. These studies are characterized by their iterative nature, allowing device modifications based on findings gathered during the study. The United States was the first to establish a specific regulatory framework for EFS, promoting structured dialogue between manufacturers and health authorities. This clarity has increased the country's attractiveness for research and development in the medical device field. In the European Union, although some EFS are conducted, their implementation remains limited due to the absence of a harmonized framework. This raises concerns about study safety and the potential migration of innovations toward the U.S. market. To address this, the European Commission supported the launch in 2023 of the project “Harmonised approach to Early feasibility Studies for medical devices in the European Union (HEU-EFS)”, which aims to establish a common European methodology for EFS. This work, conducted as part of the HEU-EFS initiative, seeks to raise awareness among French pharmacists about the ongoing developments and future perspectives for early clinical investigations in Europe.