MedTech Europe reaction to the provisional agreement on the Digital Omnibus on AI

MedTech Europe reaction to the provisional agreement on the Digital Omnibus on AI

Posted on 04.06.2026

After months of discussions and engagement among stakeholders, the Digital Omnibus on AI should finally soon come to an end. The Digital Omnibus Package, presented by the European Commission on 19 November, was inscribed into the broader Union effort to streamline its rules on Artificial Intelligence (AI), cybersecurity, and data.

From the very beginning, MedTech Europe has advocated for a sectoral approach for medical devices, which would see AI requirements be reflected in the sectoral legislation (the Medical Devices Regulation/MDR and the In Vitro Diagnostic Regulation/IVDR), thus avoiding overlapping obligations while maintaining high standards of safety and performance. Throughout the negotiations, MedTech Europe engaged with policymakers, European media, social media, and stakeholders, including through joint letters, advocating for a coherent and consistent regulatory framework for AI-enabled medical technologies.

The interaction between the AI Act and sectoral legislation remained a central issue in the negotiations, attracting significant debate among institutions and stakeholders. Following an initial unsuccessful trilogue on 28 April, a provisional agreement was reached on 6 May. The final text is expected to be formally endorsed and published in the Official Journal of the EU in July 2026.

One of the main takeaways of the provision agreement is the absence of a sectoral approach for medical technologies, which remain subject to parallel requirements under both the AI Act and the MDR/IVDR. At the same time, the agreement postpones the application of AI Act requirements for high-risk AI systems embedded in products, including medical technologies, from 2 August 2026 to 2 August 2028. This reflects one of MedTech Europe's key recommendations during the Digital Omnibus discussions. Other changes include narrowing the high-risk scope through revisions to the definition of "safety component", broadening the obligation regarding AI literacy, and introducing a potential mechanism to limit the application of certain AI Act requirements where sectoral legislation provides equivalent safeguards.

While the agreement does not fully resolve concerns regarding the interaction between the AI Act and the MDR/IVDR, the ongoing revision of the MDR and IVDR now offers an opportunity to continue discussions on how AI requirements can be implemented in a coherent and proportionate manner for medical technologies. Looking ahead, MedTech Europe will remain actively engaged in the MDR/IVDR revision process, building on the discussions held during the Digital Omnibus negotiations and continuing to advocate for a regulatory framework that supports innovation, patient access, and legal certainty while maintaining high standards of safety and performance.

MedTech Europe's reaction to the provisional agreement on the Digital Omnibus on AI can be found here.

For more information, contact , Manager Digital Health AI.