Not legal advice. This article is a preliminary technical guide for AI SaaS teams. Always confirm classification and obligations with qualified counsel. Effective dates reflect the Digital Omnibus updates as of July 2026.
Changelog
Updated 21 July 2026: Annex III standalone high-risk obligations deferred to 2 December 2027; Annex I embedded high-risk to 2 August 2028 (Council approval 29 June 2026). Art. 50 transparency remains 2 August 2026.
Why questionnaires replaced “trust us”
Enterprise buyers no longer accept a homepage badge. They send vendor questionnaires covering role under the AI Act, high-risk signals, transparency, oversight, subprocessors, and documentation.
If you buy AI SaaS: use this as a diligence baseline.
If you sell AI SaaS: prepare answers before the RFP lands — empty cells kill deals.
Questionnaire (copy into your RFP)
A. Identity & role
Legal entity name and country of establishment
Are you a provider, deployer, both, or GPAI provider for the offered system?
Do you place the system on the EU market or is output used in the EU?