Aligning the AI Act and the MDR/IVDR: What the AI Act simplification proposal means for AI-enabled medical devices

This article examines the European Commission’s December 2025 ‘Simplification Package’ and its implications for the regulation of artificial intelligence (AI)-enabled medical devices under the AI Act and the Medical Devices Regulations (MDR/IVDR). Her article explains how the proposed relocation of the MDR/IVDR within the AI Act is intended to reduce regulatory duplication, clarify obligations, and create a more predictable pathway for innovation while maintaining high standards of patient safety. By analysing the proposed legislative changes, relevant guidance, and industry perspectives, this article highlights how compliance for AI-enabled medical devices is expected to focus primarily on the obligations contained in Articles 8–15 of the AI Act and how these can be integrated into existing MDR/IVDR conformity assessment processes through a unified technical documentation approach. The article provides practical insight for manufacturers, Notified Bodies, and policymakers navigating the evolving European regulatory landscape as the AI Act approaches full application in August 2026, offering guidance on how to implement trustworthy, compliant AI within medical devices while supporting continued innovation in digital health.