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

PMID: 42324971 · 2026-06-25

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ZeitschriftExpert review of medical devices

Jahr2026-06-25

PMID42324971

Zusammenfassung

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. This scoping review examines pre-market regulatory pathways for elements critical for EFS implementation. A literature search was conducted in PubMed,

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