EU Regulation
EU AI Act Omnibus Trilogue Collapses; August 2026 Deadline Stands
After 12 hours of negotiations, the European Parliament, Council, and Commission fail to bridge the gap over whether AI embedded in medical devices, machinery, and vehicles faces the AI Act or sector-specific rules — pushing a final deal to at least mid-May.
The second political-level trilogue on the EU AI Act Omnibus ended without agreement on April 28–29, following roughly 12 hours of negotiations between representatives of the European Parliament, Council of the EU, and the European Commission. The sticking point — how AI systems integrated into regulated products such as medical devices, industrial machinery, and connected vehicles should be classified — proved irreconcilable in this session.
The core dispute pits member states, which want sector-specific product-safety frameworks to remain the primary regulatory layer for embedded AI, against Parliament, which insists that AI components in high-stakes hardware must carry the full compliance obligations of the AI Act regardless of the host product’s regulatory category. The Commission has proposed a compromise that would apply AI Act requirements only to “autonomous” AI decision-making functions in regulated products, but neither side found the formulation sufficient on Tuesday.
The immediate consequence is that the original August 2, 2026 deadline for compliance with AI Act high-risk system rules remains operative. Companies that banked on an Omnibus revision relaxing or deferring those obligations must now plan for the existing framework, at least through a third trilogue scheduled for May 13. Industry groups in Brussels warned that continued uncertainty will chill near-term product launches, particularly for medical AI startups that had deferred compliance investments pending the Omnibus outcome. IAPP’s analysis notes that even a May 13 deal would leave almost no runway for secondary legislation needed before August 2.