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Orphan medical devices: addressing the regulatory and access gaps in the EU and US

BackgroundOrphan medical devices remain the blind spot of rare disease policy. While the United States has recognized them since 1990 through the Humanitarian Use Device (HUD) and Humanitarian Device Exemption (HDE) framework, the European Union only introduced a non-binding definition in 2024 (MDCG...

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Principais autores: Sanae Akodad, Baptiste Haon, Lise Rochaix, Hilde Stevens
Format: Artigo
Sprog:Inglês
Udgivet: Frontiers Media S.A. 2026-01-01
Serier:Frontiers in Public Health
Fag:
access pathways
adaptive evidentiary pathways
argus ii
Berlin heart EXCOR
economic incentives
evidentiary standards
Online adgang:https://www.frontiersin.org/articles/10.3389/fpubh.2025.1729821/full
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