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

ABSTRACT:

Background

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 Medical Device Regulation (EU MDR 2017/745) and the phased introduction of the European Union Artificial Intelligence (EU AI) Act, creates additional complexity for DHT developers. Despite the recognized potential of EFSs to support iterative, user-centered innovation, little is known

SUBMITTER: Peseke M 

PROVIDER: S-EPMC12500223 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature