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European Union: Digital Omnibus on AI Regulation including performance monitoring requirement for "high-risk AI systems" entered into force with grace period

Policy overview

Description

Digital Omnibus on AI Regulation including performance monitoring requirement for "high-risk AI systems" entered into force with grace period

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 with a grace period. The post-market monitoring and serious incident rep…

Scope

Policy Area
Design and testing standards
Policy Instrument
Performance monitoring 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 adopted its position at first reading on the proposal for …

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 grace period

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

2026-08-02
in force

On 2 August 2026, the post-market monitoring and serious incident reporting obligations under Artic…