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.