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

Policy overview

Description

Digital Omnibus on AI Regulation (2025/0359) including changes to business registration requirement for "high-risk AI systems" entered into force

On 27 July 2026, the Regulation on the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI Regulation) entered into force. The Regulation simplifies the content required for registration of AI s…

Scope

Policy Area
Authorisation, registration and licensing
Policy Instrument
Business registration requirement
Regulated Economic Activity
ML and AI development
Implementation Level
supranational
Government Branch
executive
Government Body
central government

Complete timeline of this policy change

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2025-11-19
under deliberation

On 19 November 2025, the European Commission announced a Proposal for the Digital Omnibus on AI Reg…

2026-05-07
under deliberation

On 7 May 2026, the European Parliament and the Council of the EU reached a provisional agreement on…

2026-06-16
under deliberation

On 16 June 2026, the European Parliament passed a Regulation on the simplification of the implement…

2026-06-29
adopted

On 29 June 2026, the Council of the European Union adopted the Regulation on the simplification of …

2026-07-27
in force

On 27 July 2026, the Regulation on the simplification of the implementation of harmonised rules on …