European Union: Performance monitoring requirement for "high-risk AI systems" in Digital Omnibus on AI Regulation (Regulation 2026/174)
Progress
Scope
Timeline of events
Digital Omnibus on AI Regulation bringing forward Annex I Section A high-risk AI system performance monitoring requirement becomes applicable
On 2 August 2026, the post-market monitoring and serious incident reporting obligations under Articles 72 and 73 of the AI Act become applicable to providers of high-risk AI systems classified under Article 6(1) and Annex I, Section A. This is broug…
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…
Council of the European Union adopted Digital Omnibus on AI Regulation including performance monitoring requirements for "high-risk AI systems"
On 29 June 2026, the Council of the European Union adopted the Regulation on the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI Regulation). The Regulation will enter into force three days …
European Parliament passed Digital Omnibus on AI Regulation including performance monitoring requirement for "high-risk AI systems"
On 16 June 2026, the European Parliament adopted its position at first reading on the proposal for a Regulation on the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI Regulation). The vote p…
European Parliament and Council of the EU reached provisional agreement on Digital Omnibus on AI Regulation including performance monitoring requirement 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. The provisional agreement would set fixed application dates for the high-risk AI system obligations under Chapt…
European Commission announced Proposal for Digital Omnibus on AI Regulation (2025/0359) including performance monitoring 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). The Proposal would limit the sequencing mechanism it introduced to Chapter III, Sections 1 to 3, of the AI Act. Because the post-…