The Council and Parliament reached political agreement on 7 May 2026 on the EU Digital Omnibus, which moves the high-risk deadlines of the AI Act. Stand-alone high-risk systems shift from August 2026 to December 2027. AI embedded in regulated products, which includes AI that is itself a medical device under the MDR or IVDR, moves from August 2027 to 2 August 2028.<\/p>\n
The risk tiers and obligations are unchanged, so such products still need to satisfy both the AI Act and the medical device regulations. The conditional trigger tied to the readiness of standards was replaced with fixed calendar dates. The analysis notes that the Omnibus becomes binding only once it is formally adopted and published, so manufacturers should confirm the final text.<\/p>\n
Why it matters:<\/strong> manufacturers selling AI-enabled equipment into Europe gain time, but not a pause. Documentation, data governance and risk management work still has to be ready.<\/p>\n