Deadline and scoping page for AI embedded in Annex I regulated products such as medical devices, machinery, vehicles, toys, lifts, and radio equipment.
Changed by Omnibus Original: August 2, 2027
Obligations for high-risk AI embedded in Annex I regulated products, including medical devices, machinery, vehicles, toys, lifts, and radio equipment, are moved from the original date by the Digital Omnibus on AI.
Changed by the Digital Omnibus on AI, pending Official Journal publication for legal effect.
The current date and Omnibus-shifted original date are shown above from the deadline data.
Medical devices, machinery, vehicles, toys, lifts, radio equipment, and other regulated products can create Annex I exposure where AI is a safety component or embedded in the product conformity pathway.
Annex I systems sit inside existing product-safety regimes. The AI Act analysis should be coordinated with product conformity, technical documentation, and sector-specific regulatory work.