Annex I (AI Act)

Lists the product-safety sectoral legislation under which AI components embedded in covered products (medical devices, aviation, motor vehicles, toys, machinery) are classified as high-risk under Article 6(1). Section A of Annex I covers most EU harmonisation legislation where an AI safety component triggers high-risk status. Section B covers union harmonisation legislation where AI safety components trigger high-risk status and the Omnibus provides a different transition (amendments integrate into sectoral law upon Omnibus entry into force, per COM(2025) 836 Explanatory Memorandum, para 31, 19.11.2025).

The AI Act's category covering AI systems embedded in products already regulated by existing EU sectoral safety law (such as machinery, medical devices, and in-vitro diagnostic devices), whose conformity-assessment architecture was the specific dispute that stalled the Digital Omnibus trilogue on April 28, 2026, and whose obligations were ultimately deferred to August 2, 2028.

The list of Union harmonisation legislation whose product families can trigger Article 6(1) high-risk classification; divided into Section A (12 New Legislative Framework instruments, including MDR and IVDR) and Section B (8 other instruments, including motor vehicles and civil aviation).

The list of Union harmonisation legislation that, when applicable to a product, can trigger Article 6(1) high-risk classification. Divided into Section A (New Legislative Framework-based legislation, including MDR and IVDR) and Section B (other harmonisation legislation including aviation, rail, and automotive).