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<p>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.</p>

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年3月9日

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

摘要

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.