Guidelines
Draft Commission Guidelines on the classification of high-risk AI systems under the AI Act
Three related draft documents: general principles, the Annex I route and the Annex III route. The Annex I route covers AI that is a safety component of or itself a product under EU harmonisation legislation with third-party conformity assessment. The Annex III route goes through the eight use cases with non-exhaustive examples of systems that are and are not high-risk, plus the exceptions in Article 6, paragraph 3. Not yet adopted; the targeted consultation has closed and the final version follows later. Each timeline in the draft must be tested against the Digital Omnibus: Annex III standalone applies from 2 December 2027, Annex I embedded from 2 August 2028.
What this means for you
Manufacturers and purchasers of products with AI in them must already know now whether their system will become high-risk via the product legislation route, because the technical documentation and conformity assessment require years of preparation.
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