Classification grid and evidence matrix for evaluating digital medical devices under the European union landscape
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24 mai 2025
- ISIDORE Id: 10670/1.c958ef...
- hal: hal-05084641
- doi: 10.1038/s41746-025-01697-w
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info:eu-repo/semantics/altIdentifier/doi/10.1038/s41746-025-01697-w
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Magali Boers et al., « Classification grid and evidence matrix for evaluating digital medical devices under the European union landscape », HAL SHS (Sciences de l’Homme et de la Société), ID : 10.1038/s41746-025-01697-w
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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 Classification Grid for DMDs (CEUGrid-DMD) associated with an Evidence Matrix is developed. These tools are based on the mapping of existing frameworks, a survey of Health Technology Assessment (HTA) practices, consensus meetings and workshop. The survey was sent to 32 national representatives of HTA bodies from 18 EU countries. Ten HTA bodies from nine countries completed the survey while others could not, in the absence of the effective implementation of a DMD evaluation framework. This work results in the CEUGrid-DMD including four taxonomy categories, associated with an evidencebased matrix. Overall, this first version should help to converge scientific assessments of DMDs in the context of HTA Regulations across the EU.
