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Data-driven medical devices and the EU MDR: mapping gaps in standards for regulatory compliance.

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Title: Data-driven medical devices and the EU MDR: mapping gaps in standards for regulatory compliance.
Authors: Atmaca UI; WMG, University of Warwick, Coventry, UK. ugur-ilker.atmaca@warwick.ac.uk.; Abdullah Gul University, Kayseri, Turkey. ugur-ilker.atmaca@warwick.ac.uk., Islam SU; WMG, University of Warwick, Coventry, UK., Epiphaniou G; WMG, University of Warwick, Coventry, UK., Khadka A; WMG, University of Warwick, Coventry, UK., Harrison S; WMG, University of Warwick, Coventry, UK., Matragkas N; CEA, List, Université Paris-Saclay, 2 Bd Thomas Gobert, Palaiseau, France., Hansen S; The Open Group, Brussels, Belgium., DeLong R; The Open Group, Brussels, Belgium., Maple C; WMG, University of Warwick, Coventry, UK.; The Alan Turing Institute, London, UK.
Source: Npj health systems [Npj Health Syst] 2026 Mar 09; Vol. 3 (1). Date of Electronic Publication: 2026 Mar 09.
Publication Type: Journal Article; Review
Journal Info: Publisher: Nature Publishing Group UK Country of Publication: England NLM ID: 9918956761506676 Publication Model: Electronic Cited Medium: Internet ISSN: 3005-1959 (Electronic) Linking ISSN: 30051959 NLM ISO Abbreviation: Npj Health Syst Subsets: PubMed not MEDLINE
Database: MEDLINE Ultimate
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  Data: <searchLink fieldCode="AU" term="%22Atmaca+UI%22">Atmaca UI</searchLink>; WMG, University of Warwick, Coventry, UK. ugur-ilker.atmaca@warwick.ac.uk.; Abdullah Gul University, Kayseri, Turkey. ugur-ilker.atmaca@warwick.ac.uk.<br /><searchLink fieldCode="AU" term="%22Islam+SU%22">Islam SU</searchLink>; WMG, University of Warwick, Coventry, UK.<br /><searchLink fieldCode="AU" term="%22Epiphaniou+G%22">Epiphaniou G</searchLink>; WMG, University of Warwick, Coventry, UK.<br /><searchLink fieldCode="AU" term="%22Khadka+A%22">Khadka A</searchLink>; WMG, University of Warwick, Coventry, UK.<br /><searchLink fieldCode="AU" term="%22Harrison+S%22">Harrison S</searchLink>; WMG, University of Warwick, Coventry, UK.<br /><searchLink fieldCode="AU" term="%22Matragkas+N%22">Matragkas N</searchLink>; CEA, List, Université Paris-Saclay, 2 Bd Thomas Gobert, Palaiseau, France.<br /><searchLink fieldCode="AU" term="%22Hansen+S%22">Hansen S</searchLink>; The Open Group, Brussels, Belgium.<br /><searchLink fieldCode="AU" term="%22DeLong+R%22">DeLong R</searchLink>; The Open Group, Brussels, Belgium.<br /><searchLink fieldCode="AU" term="%22Maple+C%22">Maple C</searchLink>; WMG, University of Warwick, Coventry, UK.; The Alan Turing Institute, London, UK.
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  Data: <searchLink fieldCode="JN" term="%229918956761506676%22">Npj health systems</searchLink> [Npj Health Syst] 2026 Mar 09; Vol. 3 (1). <i>Date of Electronic Publication: </i>2026 Mar 09.
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        Value: 10.1038/s44401-026-00075-2
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              Text: 2026 Mar 09
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