Classification grid and evidence matrix for evaluating digital medical devices under the European union landscape

Classification grid and evidence matrix for evaluating digital medical devices under the European union landscape

Abstract A uniform and harmonised taxonomy of Digital Medical Devices (DMDs) and their evidence-based evaluation are essential to ensure their integration into healthcare systems across the European Union (EU). As part of the Taskforce for Harmonised Evaluation of DMDs, a Common European Classificat...

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Main Authors: Magali Boers, Aude Rochereau, Louisa Stuwe, Lorena San Miguel, Jochen Klucken, Fruzsina Mezei, Jérôme Fabiano, Sandrine Boulet, Aymeric Perchant, Rosanna Tarricone, Francesco Petracca, Barbara Hoefgen, Corinne Collignon, Sarah Zohar, On behalf of the European Taskforce for Harmonised Evaluation of Digital Medical Devices (DMDs) (EvalEUDMD)
Format: Article
Language:English
Published: Nature Portfolio 2025-05-01
Series:npj Digital Medicine
Online Access:https://doi.org/10.1038/s41746-025-01697-w
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https://doi.org/10.1038/s41746-025-01697-w

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