npj Digital Medicine (Oct 2024)

Towards harmonizing assessment and reimbursement of digital medical devices in the EU through mutual learning

  • Rosanna Tarricone,
  • Francesco Petracca,
  • Hannah-Marie Weller

DOI
https://doi.org/10.1038/s41746-024-01263-w
Journal volume & issue
Vol. 7, no. 1
pp. 1 – 12

Abstract

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Abstract Digital medical devices (DMDs) present unique opportunities in their regulation and reimbursement. A dynamic landscape of DMD assessment frameworks is emerging within the European Union, with five clusters of prevailing approaches identified. Despite notable gaps in maturity levels, cross-country learning effects are becoming prevalent. We expect more countries, both within the EU and beyond, to follow the steps of current frontrunners, hence expediting the harmonization process.