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

Abstract

Orphan 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 2024-10), revealing a deeper asymmetry: flexibility is codified in the US but interpreted in the EU. We conducted a document-based policy analysis (1990-2025) and examined legislation, regulatory guidance, and