Artificial Intelligence in Medical Devices: Integrated Interpretation of the AI Act and MDR/IVDR

2025

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This document provides a comprehensive guide to navigating the regulatory landscape for AI-enabled medical devices, integrating the requirements of the AI Act with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

* Detailed breakdown of how the AI Act applies to medical devices and how to determine high-risk classification.
* Analysis of the lifecycle workflow, quality management, data governance, and technical documentation requirements for AI-driven medical devices.
* Guidance on transparency, human oversight, cybersecurity, and the implementation timeline for compliance.

AI Act, MDR, IVDR, medical devices, regulatory compliance

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