Pre-market clinical investigation approval pathways and the role of Early Feasibility Studies for medical devices: a scoping review to guide EU policy

INTRODUCTION: Early Feasibility Studies (EFS) enable limited early-stage clinical evaluation of novel medical devices when non-clinical testing is insufficient to inform design, safety, or performance. While the US Food and Drug Administration has an established EFS program, the EU lacks a dedicated framework, creating uncertainty for innovators and regulators. AREAS COVERED: This scoping review examines pre-market regulatory pathways for elements critical for EFS implementation. A literature search was conducted in PubMed, Scopus, and Web of Science without time or geographic restrictions. Eight key dimensions were identified, primarily across EU and US systems: regulatory frameworks; eligibility criteria and preclinical evidence; iterative innovation mechanisms; early dialogue; structural and medico-legal challenges; clinical site capacity; risk management; and patient communication, involvement, and safety. The FDA model supports EFS through clear guidance, flexible testing, early dialogue, and support for protocol and device iteration. In contrast, EU regulation acknowledges early investigations but lacks a dedicated framework, resulting in fragmented implementation. EXPERT OPINION: A coherent EU EFS framework could strengthen patient protection by improving regulatory clarity, oversight, and the quality and timeliness of early-stage evidence, accelerating innovation and strengthening European competitiveness. Priority actions include formal guidance, structured early dialogue, capacity building, harmonized liability, and enhanced patient involvement.