EU AI Act — Embedded High-Risk (Annex I)

EU · Effective August 2, 2028

What it is

Annex I covers AI embedded in products already governed by EU product-safety law: medical devices, machinery, toys, lifts, radio equipment. Where AI is a safety component of such a product, the high-risk regime applies through the product's existing conformity framework. The Digital Omnibus moved this deadline from August 2, 2027 to August 2, 2028.

Does it apply to you?

For typical SaaS: no. This tier concerns physical, safety-regulated products. It becomes relevant if your software is a component in a medical device or machinery-adjacent system, such as diagnostic software classified as a medical device under the MDR, in which case you already live in conformity-assessment world and this page is not news.

What SaaSalyst checks

Nothing here, and no URL scanner could. Included so the compliance timeline on this site is complete rather than conveniently truncated.

Official text: https://eur-lex.europa.eu/eli/reg/2024/1689/oj

FAQ

Why list a deadline that doesn't apply to most readers?

Because half-timelines breed bad decisions. When you see "EU AI Act deadline 2028" quoted elsewhere, this page tells you which obligations that date covers, and that your transparency duties came due in 2026, not 2028.

Sources

Regulation (EU) 2024/1689, Annex I; Regulation (EU) 2026/1744 (in force Jul 27, 2026).

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