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

Early access to medical devices in Europe relies on EU regulatory derogations and heterogeneous national schemes. The landscape remains fragmented and unevenly documented. We recommend: (1) a more structured EU-level route for high-risk and combination products, (2) lifecycle-based national schemes integrating regulatory and payer access, (3) measures to reduce inequities and administrative barriers, particularly in Central and Eastern Europe, and (4) improved transparency and standardised data collection on implemented pathways.