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

Ugur Ilker Atmaca; Saif ul Islam; Gregory Epiphaniou; Anita Khadka; Stuart Harrison; Nikolaos Matragkas; Scott Hansen; Rance DeLong; Carsten Maple

doi:10.1038/s44401-026-00075-2

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

npj Health Systems 2026 Open access

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Authors: Ugur Ilker Atmaca, Saif ul Islam, Gregory Epiphaniou, Anita Khadka, Stuart Harrison, Nikolaos Matragkas, Scott Hansen, Rance DeLong, Carsten Maple

DOI: 10.1038/s44401-026-00075-2

Cited by: 5

References: 33

Abstract

Data-driven medical devices promise significant enhancements to diagnostic accuracy, personalised treatments, real-time patient monitoring, and clinical decision support. However, these innovations present regulatory challenges. This study maps the current European Union Medical Device Regulation requirements against international data safety and quality assurance standards, identifying critical gaps. It highlights challenges in data quality, algorithm transparency, risk management, continuous validation, and synthetic data use. Recommendations are proposed to support regulatory adaptation.

Fields of Study & Subjects

Artificial Intelligence in Healthcare and Education Healthcare Technology and Patient Monitoring Electronic Health Records Systems

Publication details

Journal / source: npj Health Systems
Publisher: Springer Science and Business Media LLC
Volume: 3
Issue: 1
Publication date: 9 March 2026
Language: EN

References 33