Legislative change must fix the European Union’s disharmonized map of early-stage medical device clinical study requirements, whereby fragmented interpretations across Member States create barriers to <a href="https://healthylife7.com/tozo-on-innovation-accessibility-and-the-future-of-lifestyle-tech/” title=”TOZO on Innovation, Accessibility and the Future of Lifestyle Tech”>innovation and delay patient access to life-saving technologies
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Funding
F.R.K. receives support from the German Cancer Research Center (CoBot 2.0), the Central Indiana Corporate Partnership AnalytiXIN Initiative, the Jung Foundation for Science and Research (Jung Career Advancement Award), the Evan and Sue Ann Werling Pancreatic Cancer Research Fund, and the Indiana Clinical and Translational Sciences Institute, funded, in part, by the National Institutes of Health, National Center for Advancing Translational Sciences, Clinical and Translational Sciences Award (UM1TR004402). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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Authors and Affiliations
Weldon School of Biomedical Engineering, Purdue University, West Lafayette, IN, USA
Muhammad Ibtsaam Qadir & Fiona R. Kolbinger
Else Kröner Fresenius Center for Digital Health, Faculty of Medicine Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany
Juliane Wober, Stephen Gilbert & Fiona R. Kolbinger
Institute for Clinical Trials, College of Medicine, Nursing & Health Sciences, University of Galway, Galway, Ireland
Ali McDonnell & Tom Melvin
MedTech Europe, Brussels, Belgium
Jana Russo
Department of Visceral, Thoracic and Vascular Surgery, University Hospital and Faculty of Medicine Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany
Fiona R. Kolbinger
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Contributions
J.W. and F.R.K. conceptualized this work. M.I.Q. and J.W. collected data. M.I.Q., J.W., A.M., J.R., T.M., S.G. and F.R.K. contributed to data analysis and interpretation. M.I.Q. and F.R.K. drafted the manuscript. All authors read, edited and approved the final manuscript version
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Competing interests
F.R.K. declares ongoing advisory roles for the Surgical Data Science Collective and Scopia AI, and has received research funding from Novartis. S.G. has or has had consulting relationships with Una Health, Lindus Health, Flo, Icura, Rock Health, Thymia, FORUM Institut für Management, High-Tech Gründerfonds Management, DG SANTE, Prova Health, Haleon and Ada Health, and holds share options in Ada Health. The other authors declare no competing interests
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Qadir, M.I., Wober, J., McDonnell, A. et al. EU’s fragmented early-stage medical device study requirements need reform.
Nat. Biomed. Eng (2026). https://doi.org/10.1038/s41551-026-01750-3
Published:31 July 2026
Version of record:31 July 2026
DOI
:https://doi.org/10.1038/s41551-026-01750-3
