"Towards harmonizing assessment and reimbursement of digital medical devices in the EU through mutual learning".
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 39354125.
- Also identified by DOI 10.1038/s41746-024-01263-w and PMC identifier 11445240.
- Licence recorded as CC BY-NC-ND.
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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.