Simplification for AI Medical Devices?
Published on 12th January 2026
How the European Commission’s proposal on amending the MDR and IVDR adds to the simplification efforts by the Digital Omnibus packages for AI-enabled medical devices and IV diagnostic devices
This article was authored by Julia Kaufmann, Dr. Florian Eisenmenger and Marina Fröhlich.
What are the proposals about?
On 19 November, the European Commission published the Digital Omnibus on AI which seeks to simplify the AI Act. On 16 December 2025, the European Commission published its proposal for amending the Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) to simplify existing rules (MDR and IVDR proposal). The MDR and IVDR proposal includes amendments to the AI Act adding to the simplification efforts of the Digital Omnibus on AI.
Why and how will the MDR and IVDR proposals impact AI-enabled medical devices?
With the MDR and IVDR proposal, the European Commission seeks to ensure uniform and coherent rules for AI-enabled medical devices and IV diagnostic devices, establishing a leaner and more cost-effective regulatory framework. With respect to AI, this shall be achieved by moving the reference to MDR and IVDR from Annex I Section A to Annex I Section B of the AI Act. Thereby, the AI Act would apply only to a limited extent to AI-enabled medical devices and IV diagnostic devices that qualify as high-risk AI systems, Art. 2 (2) AI Act.
