Bridging Regulatory Gaps in Data-Driven Medical Devices

A new publication in npj Health Systems (by Nature Portfolio) sheds light on one of the most pressing challenges in digital health: aligning data-driven medical devices with the EU Medical Device Regulation (MDR).

The paper, “Data-driven medical devices and the EU MDR: mapping gaps in standards for regulatory compliance”, explores how current technical standards fall short in addressing the complexity of AI-enabled and data-driven technologies. As these systems become more adaptive and data-dependent, ensuring compliance with MDR requirements is increasingly challenging.

Developed through collaboration between the University of Warwick, Ethos, CEA, and The Open Group, the study provides a structured analysis of regulatory gaps and highlights areas for improvement.

For the INSAFEDARE project, this publication strengthens dissemination efforts under WP7 and contributes to advancing safe, compliant, and trustworthy digital health innovation.

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

https://www.nature.com/articles/s44401-026-00075-2.pdf