European Commission Finalizes Artificial Intelligence Act: A Milestone for AI in Medical Devices

The European Commission has officially published the finalized text of the Artificial Intelligence Act (AIA), marking a significant milestone in AI regulation. As the world’s first comprehensive AI law, the AIA is designed to foster the development and deployment of “human-centric and trustworthy” AI across various sectors, including medical devices and in vitro diagnostic devices (IVDs). Published in the Official Journal on July 12, 2024, the Act will come into effect on August 2, 2024. However, the requirements specifically targeting high-risk devices will be enforced starting August 2, 2026.

Key Provisions of the Artificial Intelligence Act

• Human-Centric and Trustworthy AI: The AIA aims to ensure that AI systems, particularly those used in medical and diagnostic contexts, are developed and used in a manner that prioritizes human well-being and trust.
• Harmonized Market Rules: The Act introduces standardized rules for the placement of AI-powered products on the market, creating a consistent regulatory framework across the European Union.
• First Comprehensive AI Law: Recognized as the world’s first comprehensive AI legislation, the AIA represents a pioneering approach to regulating AI technology on a broad scale.

Companies in the medical device and IVD industries should begin preparing for compliance with the AIA. This preparation involves evaluating current and future AI-enabled products against the Act’s requirements, especially for those classified as high-risk, to meet the necessary standards by the August 2026 deadline.

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