Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: Qualitative Interview Study.

Abstract

Early feasibility studies (EFSs) are small-scale clinical investigations conducted during the early development of medical devices to assess initial safety and performance, especially when bench or in-silico testing is insufficient. While EFSs are well established for hardware devices, their application to digital health technologies (DHTs) including artificial intelligence (AI)-enabled medical devices remains limited. The rapidly evolving regulatory landscape, including the European Union Medic