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

Background: 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. Research design and methods: A mixed-methods study was conducted via an online survey and virtual workshop involving 23 NCAs. Outcome measures included assessor assignment models, qualifications, training, use of external experts, sponsor dialogue mechanisms, and preparedness for emerging technologies. Data were thematically analyzed to assess systemic readiness and capacity. Results: There is variability in the documentation of clinical investigation phases and assessment practices. Gaps in NCA resources were notable in digital health technology (DHTs) and artificial intelligence-enabled medical devices (AIeMD) and statistics. Dialogue mechanisms were present in 63% of NCAs and associated with improved submission quality. Training was fragmented and use of external experts limited. NCAs emphasized regulatory strain due to rising complexity. Conclusions: There is significant variability in assessor qualifications and practices. These differences limit the consistency of regulatory oversight under the MDR. Establishing structured training programs, and harmonized sponsor dialogue mechanisms will be critical to supporting regulatory preparedness and coherence.