AI Act deal lands: what it means for the medical technology sector?
Posted on 07.05.2026
In the early hours of this morning, 7 May 2026, EU co-legislators reached a political agreement on the Digital Omnibus, amending the AI Act. The deal confirms that medical technologies will remain subject to the AI Act’s high-risk requirements. Industrial AI applications secured an exemption following sustained pressure from Germany; medical devices did not.
This is not the outcome MedTech Europe sought. We had advocated clearly and consistently for a single, sector-specific compliance pathway, whereby high-risk AI requirements for medical technologies are implemented through the existing Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), rather than through parallel obligations under both frameworks.
What we argued
Alongside COCIR and DIGITALEUROPE, MedTech Europe engaged directly with Commission President von der Leyen and Member State Permanent Representatives to make the case for regulatory coherence. The argument was straightforward: the MDR and IVDR already establish rigorous, fit-for-purpose requirements for safety and performance. Layering AI Act obligations on top does not raise the bar; it adds complexity, increases administrative burden, and risks slowing patient access to innovative technologies.
In its Digital Omnibus proposal, the European Commission reaffirmed the horizontal nature of the AI Act, while proposing to delay the application of high-risk AI requirements for certain products, including medical devices, until the necessary standards, guidance and compliance infrastructure are in place. Under that approach, AI Act requirements would continue to apply directly, with sectoral legislation shaping their practical implementation and conformity assessment pathways. The European Parliament went further, supporting full integration of AI requirements into sectoral legislation, which would have meant a single, streamlined compliance pathway for medical technologies. It was the Council’s position, maintaining parallel requirements under both the AI Act and the MDR/IVDR, that ultimately prevailed.
Where the advocacy goes next
Today’s outcome makes one thing clear: the MDR and IVDR revision is now the critical vehicle for addressing the concerns that were not resolved in the Digital Omnibus. Both regulations are already undergoing targeted revision, and this process offers a concrete opportunity to ensure that AI-related requirements are embedded coherently within the sectoral framework, avoiding duplication and legal uncertainty while fully preserving patient safety.
MedTech Europe will continue to engage actively in that process, building on the arguments made during the Digital Omnibus discussions and working with legislators to deliver a framework that is effective, workable and proportionate.
What we are asking
We call on EU legislators and the European Commission to use the MDR/IVDR revision to address the regulatory coherence gap left by today’s deal. Specifically, we urge that high-risk AI requirements for medical technologies be implemented through the sectoral framework, with no duplication of conformity assessment obligations.
If you share this view, we encourage you to engage with your national representatives and make your voice heard as the MDR/IVDR revision advances. MedTech Europe stands ready to coordinate and support those efforts.
For more information, please contact Leander Vranken, Manager Digital Health AI.