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

Abstract

Introduction: 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. Areas covered: 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. Expert opinion: 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.