Early Feasibility Studies in Europe: A Multisite Qualitative Study of Operational Challenges and Site Selection...

Early feasibility studies (EFS) are critical to high-risk medical devices development, providing initial insights into safety, performance, and usability. However, the lack of a harmonized European Union regulatory framework creates significant barriers to their consistent and efficient conduct. This study examined current EFS practices in European university hospitals to identify key regulatory and operational challenges and inform future harmonization efforts.

A qualitative, multisite study was conducted involving 6 European university hospitals in November 2024 and July 2025. Experts involved in EFS or comparable early-phase clinical investigations participated in semistructured interviews. Participants were eligible if they were currently involved in, or had prior experience with, early-phase medical device or methodologically comparable clinical research; no role-based exclusion criteria were applied. A standardized questionnaire covering 6 thematic areas including a weighted scoring system to assess site selection criteria was developed to guide the interviews, and data collection and analysis followed the Consolidated Criteria for Reporting Qualitative Research (COREQ) 32-item checklist. Site-level findings were analyzed through qualitative and descriptive content analysis validated by a multidisciplinary review team. Quantitative data from the site‑selection exercise were summarized using nonparametric descriptive statistics. As this was an organizational and process‑focused qualitative study, no clinical outcomes or adverse events were assessed.

Twenty-one participants representing clinical, regulatory, operational, and ethics roles were included. Investigator expertise and engagement emerged as the most influential determinants of EFS success and site selection, followed by institutional readiness and operational infrastructure. Participants consistently reported challenges related to regulatory fragmentation, variable interactions with ethics committees and competent authorities, contract and budget negotiation processes, and uneven clinical research organization experience in early-phase device research. Six overarching themes were identified: investigator capacity and engagement; clinical site readiness and feasibility; regulatory environment and governance; operational infrastructure and clinical research organization capacity; financial and organizational constraints; and structural and ecosystem-level factors. Several challenges paralleled those reported in the United States despite different regulatory contexts.

The findings indicate that EFS implementation in Europe is constrained by interdependent regulatory, operational, and organizational barriers linked to the absence of a harmonized European Union EFS framework. Although the limited number of sites and qualitative design restrict generalizability, the results provide empirically grounded insight into current European EFS practices. These findings support the need for coordinated guidance, standardized processes, and structured stakeholder interaction to improve the feasibility, consistency, and efficiency of early-phase medical device investigations in Europe.