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A list of products already regulated by EU health and safety law (e.g., machinery, medical devices) where AI integrated under the EU AI Act is automatically classified as high-risk.
Under EU AI Act Article 6(1), if an AI system serves as a safety component for a product listed in Annex I - such as a lift, pressure equipment, or a motor vehicle - the system is high-risk. These systems must undergo third-party conformity assessments as part of the overall product's certification process, ensuring AI safety is baked into existing industrial standards.
Real world example:
A manufacturer develops an AI-driven braking system for an autonomous tractor; because tractors fall under EU AI Act Annex I machinery regulations, the AI is high-risk and requires rigorous safety testing.




