Recommendations for the design and implementation of an Early Feasibility Studies program for medical devices in the European Union

• Published in: Expert review of medical devices Vol. 19; no. 4; pp. 315 - 325
• Main Authors: Callea, Giuditta, Federici, Carlo, Freddi, Rachele, Tarricone, Rosanna
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 03.04.2022
• Subjects: Clinical evidence; early feasibility study; European Union; Health Technology Assessment regulation; medical devices; medical devices regulation; pre-market clinical investigation; early feasibility study; medical devices; European Union; Medical Devices Regulation; Clinical evidence; pre-market clinical investigation; Health Technology Assessment Regulation
• ISSN: 1743-4440; 1745-2422
• DOI: 10.1080/17434440.2022.2075729

Early Feasibility Studies (EFS) are among the pre-market clinical investigations allowed by the International Standard for Clinical investigation of medical devices (MD) for human subjects. The Food and Drug Administration (FDA) introduced an EFS program in the US in 2013. The European Union (EU) MD Regulation, that entered into force in May 2021, opened the possibility of EFS in the EU. However, European countries at present have no standardized procedural framework for EFS. In this paper, we address the desirability of a European EFS program. Characteristics of EFS conducted so far are reviewed, and perceptions of an expert, multidisciplinary panel of key stakeholders are explored regarding desirability and feasibility of a European EFS program and critical factors favoring or hampering its implementation. Implementing an EFS program in the EU would contribute to creating a favorable environment for early-stage clinical investigations, with positive effects on the quality and timeliness of clinical evidence for novel MDs, and attractiveness of the European system for pre- and post-market clinical research. Based on discussion with experts, also leveraging on the US experience, three dimensions should be considered for effective design and implementation: process, resources, and ethical issues.