European Union: Changes to business registration requirement for "high-risk AI systems" in Digital Omnibus on AI Regulation (2025/0359)
Progress
Scope
Timeline of events
European Parliament passed Digital Omnibus on AI Regulation (2025/0359) including changes to business registration requirement for "high-risk AI systems"
On 16 June 2026, the European Parliament passed a Regulation on the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI Regulation). The vote passed with 423 votes in favour, 57 against, and 174…
European Parliament and Council of the EU reached provisional agreement on Digital Omnibus on AI Regulation (2025/0359) including changes to business registration requirements for high-risk AI systems
On 7 May 2026, the European Parliament and the Council of the EU reached a provisional agreement on the Digital Omnibus on AI Regulation (2025/0359). The Digital Omnibus on AI Regulation would require providers to register AI systems in the EU datab…
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 Propo…