Regulatory readiness for innovation: a mixed-methods study of national competent authority professional and organizational capacities in the context of pre-market clinical investigations and early feasibility studies.

Abstract

Early Feasibility Studies (EFS) support early-stage evaluation of novel technologies. Under the European Union Medical Device Regulation (EU MDR 2017/745), National Competent Authorities (NCAs) assess these investigations. However, little is known about their organizational readiness and ability to assess complex technologies in a consistent and coordinated manner. A mixed-methods study was conducted via an online survey and virtual workshop involving 23 NCAs. Outcome measures included assessor