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

PMID: 41032887 · 2025-10-01

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학술지Journal of medical Internet research

연도2025-10-01

PMID41032887

초록

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

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