Logo KAN Kommission Arbeitsschutz und Normung. To the cover page Logo KAN Kommission Arbeitsschutz und Normung. To the cover page

Proposed amendments to the AI Act

Ordner auf Schreibtisch mit Beschriftung "EU-Verordnung" neben Paragraf und Waage. © MQ-Illustrations – stock.adobe.com

In November 2025, the European Commission presented the Digital Omnibus on AI Regulation Proposal for amendment of the AI Act. The amendments proposed in the omnibus may also have an impact on the safety of persons at work. In particular, the date of application of the provisions for high-risk AI is to be postponed. The background to this particular proposal is that the harmonised standards supporting the requirements of the Act have still not been published. The Commission is therefore now proposing a mechanism that links the start of application of the provisions to a decision confirming that the required standards and supporting instruments are available.

The Digital Omnibus is not the only proposal by the Commission for amendment of the AI Act. Further adjustments are to be made in a proposal to revise the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). The MDR and IVDR are to be moved from Section A (Union harmonisation legislation based on the New Legislative Framework (NLF)) to Section B (other Union harmonisation legislation) in Annex I of the AI Act. This would result in medical devices and in vitro diagnostic medical devices for AI systems that are considered high-risk under Article 6 (1) (Annex I) of the AI Act being subject to significantly fewer requirements than those provided for to date.

Comments can be submitted through the Commission’s Have Your Say portal: until 13 March 2026 for comments on the Digital Omnibus and at least until 21 April 2026 for comments on the proposed revision of the MDR and IVDR.

Back