Classification grid and evidence matrix for evaluating digital medical devices under the European union landscape
npj Digital Medicine, vol. 8, pp. 304
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 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 evidence-based matrix. Overall, this first version should help to converge scientific assessments of DMDs in the context of HTA Regulations across the EU.
Authors 31
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Affiliation as printed
Luxembourg Ministry of Health and Social Security, Luxembourg, Luxembourg
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Affiliation as printed
Mission numérique en santé, Haute Autorité de Santé, Saint-Denis, France
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Affiliation as printed
Digital Health Delegation, French Ministry of Health, Paris, France
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Belgian Health Care Knowledge Centre (KCE)
Affiliation as printed
KCE - Federaal Kenniscentrum voor de Gezondheidszorg - Centre Fédéral d'Expertise des Soins de Santé, Brussels, Belgium
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Centre Hospitalier de Luxembourg · University of Luxembourg · Luxembourg Centre for Systems Biomedicine
Affiliation as printed
Digital Medicine Group, Centre Hospitalier du Luxembourg, Luxembourg, Luxembourg
Luxembourg Centre for Systems Biomedicine (LCSB) University of Luxembourg, Esch-sur- Alzette, Luxembourg
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Affiliation as printed
EIT Health France, Paris, France
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Affiliation as printed
EIT Health France, Paris, France
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Institut national de recherche en sciences et technologies du numérique · Inserm · Université Paris Cité · Heka : Méthodes basées sur les données et modèles en santé pour l'acquisition de connaissances
Affiliation as printed
Inserm, Université Paris Cité, Inria, HeKA, Paris, France
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Affiliation as printed
Digital Health Delegation, French Ministry of Health, Paris, France
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Affiliation as printed
Centre for Research on Health and Social Care Management (CERGAS), Government, Health and Not for Profit Division, SDA Bocconi School of Management, Milan, Italy
Department of Social and Political Science, Bocconi University, Milan, Italy
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Affiliation as printed
Centre for Research on Health and Social Care Management (CERGAS), Government, Health and Not for Profit Division, SDA Bocconi School of Management, Milan, Italy
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Federal Institute for Drugs and Medical Devices
Affiliation as printed
Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany
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Affiliation as printed
Mission numérique en santé, Haute Autorité de Santé, Saint-Denis, France
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Sarah Zohar corresponding
Institut national de recherche en sciences et technologies du numérique · Inserm · Université Paris Cité · Heka : Méthodes basées sur les données et modèles en santé pour l'acquisition de connaissances
Affiliation as printed
Inserm, Université Paris Cité, Inria, HeKA, Paris, France. sarah.zohar@inserm.fr
Inserm, Université Paris Cité, Inria, HeKA, Paris, France
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Affiliation as printed
Biomedical Alliance in Europe, Brussels, Belgium
School of Medicine, Cardiff University, Cardiff, UK
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Affiliation as printed
European Observatory, Brussels, Belgium
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Politecnico di Milano, Milano, Italy
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Biomed Alliance, Oxford, UK
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FinCCHTA, Oulu University Hospital, Oulu, Finland
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University of Liège, Liège, Belgium
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EUnetHTA, Brussels, Belgium
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Affiliation as printed
Medical University of Vienna, Center for Medical Data Science, Vienna, Austria
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Agència de Qualitat i Avaluació Sanitàries de Catalunya
Affiliation as printed
Catalan Agency for Health Quality and Assessment, Barcelona, Spain
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Austrian Institute for Health Technology Assessment GmbH
Affiliation as printed
HTA Austria - Austrian Institute for Health Technology Assessment GmbH, Vienna, Austria
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Affiliation as printed
European Patients’ Forum, Brussels, Belgium
European Patients' Forum, Brussels, Belgium
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Leiden University Medical Center
Affiliation as printed
National eHealth Living Lab, Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands
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Finnish Innovation Fund Sitra, Helsinki, Finland
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Affiliation as printed
Finnish Innovation Fund Sitra, Helsinki, Finland
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Affiliation as printed
Digital Health Delegation, French Ministry of Helath, Paris, France
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Affiliation as printed
European Patients’ Forum, Brussels, Belgium
European Patients' Forum, Brussels, Belgium
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Affiliation as printed
AQUAS, Rome, Italy
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