European Union: European Commission announced Proposal for Digital Omnibus on AI Regulation (2025/0359) including changes to business registration requirement for "high-risk AI systems"

On 19 November 2025, the European Commission announced a Proposal for the Digital Omnibus on AI Regulation (2025/0359), which amends the EU AI Act by amending the registration requirements for providers of certain AI systems. Specifically, the Proposal would amend Article 6(4) of the AI Act to remove the need for providers of AI systems referred to in Annex III of that Act to register a system that they do not consider to be high-risk. Further, the Proposal would expand the scope of the simplified technical documentation requirements under Article 11 to include SMCs alongside SMEs, while also noting that the proportionality principle applying to the quality management system in Article 17 is especially relevant to SMCs and SMEs. The Proposal would also alter the implementation timeline of conformity assessment and business registration requirements for high-risk AI systems, calculating implementation periods by reference to the Commission adopting a decision confirming that adequate measures in support of compliance were available. High-risk AI systems classified according to Annex III would be required to comply 6 months after the Commission decision, while high-risk AI systems classified according Article 6(1) would be required to comply 12 months after the Commission decisions. In any case, the provisions would apply at the latest from 2 December 2027 for Annex III high-risk systems, and from 2 August 2028 for Article 6(1) high-risk systems.