Early and accelerated access programs for medical devices in the European Union: mapping regulatory derogations and national schemes.

Abstract

Early access programs (EAPs) can provide patients with medical devices before full market access in urgent or high unmet-need situations. Unlike pharmaceuticals, the European Union (EU) has no harmonised early-access framework for medical devices, resulting in fragmented national practices. We use We conducted a qualitative document-based analysis of peer-reviewed literature, grey literature (policy papers, regulatory guidance), and legal sources (EU legislation, national laws) published up to