On February 11, 2026, the German Federal Cabinet approved the AI Market Surveillance and Innovation Promotion Act (KI-MIG). The act governs the national implementation of the AI Act.
At its core, the act defines the national supervisory structure:
- The Federal Network Agency becomes the central market surveillance authority, coordination body and point of contact for the EU.
- In already regulated sectors (medical devices, for example), the existing sectoral authorities remain responsible. Designating notified bodies for medical devices and in vitro diagnostics therefore remains the task of the ZLG (Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices)
To promote innovation, the act provides for an AI service desk for SMEs and start-ups as well as a regulatory sandbox in which innovative AI systems can be tested in a legally secure environment.
Medical devices with AI that require the involvement of a notified body under the MDR (risk class IIa, for example) qualify as high-risk AI systems under the AI Act. The AI Act enters into force in stages and will apply in full by August 2, 2027. Bodies already notified under the MDR and IVDR are expected to extend their designation to cover the AI Act scope.
The bill now goes to parliamentary deliberation in the Bundestag and Bundesrat.
Read more in the press release from the BMDS: Kabinett beschließt schlanke KI-Aufsicht in Deutschland
You will find all the key information on the AI Act in our continuously updated guide: AI Act: A Guide for Medical Device Manufacturers under the MDR