Data-driven medical devices and the EU MDR: mapping gaps in standards for regulatory compliance
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.
Authors
- Rance DeLong
- Stuart Harrison (ORCID: https://orcid.org/0000-0003-3873-4512)
- Saif ul Islam (ORCID: https://orcid.org/0000-0002-9546-4195)
- Ugur Ilker Atmaca (ORCID: https://orcid.org/0000-0002-7428-3504)
- Gregory Epiphaniou (ORCID: https://orcid.org/0000-0003-1054-6368)
- Anita Khadka (ORCID: https://orcid.org/0000-0003-2361-2977)
- Nikolaos Matragkas
- Carsten Maple
- Scott Hansen
Institutions
- Commissariat à l'Énergie Atomique et aux Énergies Alternatives (FR)
- Université Paris-Saclay (FR)
- University of Warwick (GB)
- Laboratoire d'Intégration des Systèmes et des Technologies (FR)
- The Alan Turing Institute (GB)
- Abdullah Gül University (TR)
Publication Details
- Journal
- npj Health Systems
- Published
- 2026-03-09
- DOI
- https://doi.org/10.1038/s44401-026-00075-2
- Primary Topic
- Artificial Intelligence in Healthcare and Education
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- European Commission