On March 26, 2026, the European Parliament adopted its position onthe “Digital Omnibus on AI.”Following the Council’s earlier adoption of its position, trilogue negotiations are now set to begin. One of the goals of the omnibus package is to reduce overlaps between the AI Act and sector-specific regulations such as the MDR and IVDR.
At the same time, the proposal for targeted amendments to the MDR and IVDR provides that the Commission will have greater flexibility in adapting the essential safety and performance requirements (Annex I) in the future . For AI-related aspects, the requirements of the AI Act are to be taken into account.
You can read the text here: Texts Adopted – Simplification of the Implementation of Harmonized Rules on Artificial Intelligence (Digital Omnibus on AI) – Thursday, March 26, 2026