Classification grid and evidence matrix for evaluating digital medical devices under the European union landscape
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
- L. Geris
- Vincent Vercamer
- Lorena San Miguel (ORCID: https://orcid.org/0000-0002-7155-7303)
- Martin Posch (ORCID: https://orcid.org/0000-0001-8499-8573)
- Markus Kalliola
- Sandrine Boulet (ORCID: https://orcid.org/0000-0001-9863-5466)
- Rosanna Tarricone (ORCID: https://orcid.org/0000-0002-2009-9357)
- Enrico G. Caiani (ORCID: https://orcid.org/0000-0002-1770-6486)
- Magali Boers
- Димитра Пантели (ORCID: https://orcid.org/0000-0003-2110-3335)
- Johannes Ahlqvist
- Graham Dawson (ORCID: https://orcid.org/0000-0002-8361-300X)
- Alan G. Fraser (ORCID: https://orcid.org/0000-0001-7083-6995)
- Corinne Collignon
- Janne Haverinen
- Petra Hoogendoorn (ORCID: https://orcid.org/0000-0003-3824-648X)
- Fruzsina Mezei (ORCID: https://orcid.org/0000-0001-5924-9781)
- Francesco Petracca (ORCID: https://orcid.org/0000-0002-6076-6919)
- Jochen Klucken (ORCID: https://orcid.org/0000-0001-6645-9437)
- Marco Anthony Marchetti (ORCID: https://orcid.org/0000-0002-5275-5769)
- Reinhard Jeindl (ORCID: https://orcid.org/0000-0002-2620-9078)
- Marcus Guardian
- Sarah Zohar (ORCID: https://orcid.org/0000-0002-8429-2340)
- Jérôme Fabiano
- Valentina Strammiello
- R. Maspons Bosch
- Louisa Stüwe
- Barbara Hoefgen
- Aude Rochereau
- Aymeric Perchant
- J. Spony
Institutions
- Federal Institute for Drugs and Medical Devices (DE)
- Inserm (FR)
- University of Liège (BE)
- Centre Hospitalier de Luxembourg (LU)
- University of Luxembourg (LU)
- Université Paris Cité (FR)
- Oulu University Hospital (FI)
- Leiden University Medical Center (NL)
- Sorbonne Paris Cité (FR)
- Santé Publique France (FR)
- Luxembourg Institute of Health (LU)
- Ministry of Health (LA)
- Austrian Institute for Health Technology Assessment GmbH (AT)
- Sitra (FI)
- University Alliance (GB)
- Ministry of State (LU)
- Agència de Qualitat i Avaluació Sanitàries de Catalunya (ES)
- EUnited (Belgium) (BE)
- Belgian Health Care Knowledge Centre (KCE) (BE)
- European Federation of Allergy and Airways Diseases Patients Associations (BE)
- European Social Observatory (BE)
- Pontifical University of Saint Thomas Aquinas (IT)
- Ministry of Health (SZ)
- Bocconi University (IT)
- Medical University of Vienna (AT)
- Cardiff University (GB)
- Politecnico di Milano (IT)
Publication Details
- Journal
- npj Digital Medicine
- Published
- 2025-05-24
- DOI
- https://doi.org/10.1038/s41746-025-01697-w
- Citations
- 4
- Primary Topic
- Artificial Intelligence in Healthcare and Education
- Type
- article
- Field-Weighted Citation Impact
- 2.62
Funders
- Agence Nationale de la Recherche