Publication of guidance for artificial intelligence in medical devices
Year of issue 2026
Date of issue 2026.05.07
The Bundesnetzagentur, the Hessian Ministry for Digitalisation and Innovation and the Federal Commissioner for Data Protection and Freedom of Information have today published a roadmap for AI in medical devices. The roadmap provides a compact overview of the interplay between the legal requirements from the European AI Act and the Medical Device Regulation. The aim is to provide better guidance for companies and support the safe use of AI in medicine.
In March 2026 the partner authorities published their final report on the simulated AI regulatory sandbox process. The roadmap is a further deliverable from the pilot project, in which two start-ups, avisé labs GmbH and Katulu GmbH, were involved.
“Companies developing AI in medicine need clear guidance instead of regulatory uncertainty. The roadmap helps innovators in integrating the requirements from both the AI Act and the medical devices legislation. This enables sound innovation: with more legal certainty and in the interests of patients,
” explained Professor Louisa Specht-Riemenschneider, Federal Commissioner for Data Protection and Freedom of Information.
Hessian Digitalisation Minister, Professor Kristina Sinemus, said, “We want to help companies in developing responsible AI applications for the benefit of patients, which will enable us to implement safe and even more innovative medical devices in future. AI and associated innovations are based on high-quality data. A data trust agency, like the new MDTS at the Technische Hochschule Mittelhessen, can make an important contribution to enabling better use of such data as well as new research.”
“Our close cooperation with the innovative start-ups shows the importance of dialogue between companies and authorities in shaping practical regulation. The roadmap gives companies in the medical sector more certainty in the new regulatory environment,
” said Klaus Müller, President of the Bundesnetzagentur.
“Nowadays we have to successfully combine rapidly evolving technology and sets of regulations when developing digital innovation in medicine. AI regulatory sandboxes can provide just the right approach for safely establishing new technologies. The roadmap gives sound guidance to help us get a better idea of the interplay between the AI Act and the Medical Device Regulation. Cooperation between companies and authorities, as with the AI regulatory sandbox pilot project, is essential in order to be able to implement market-ready disruptive innovations in high-risk domains and thus also keep pace internationally,
” said Marius Khan, Chief Executive Officer of avisé labs GmbH.
Roadmap creates guidance on requirements for high-risk AI systems in medical devices
The roadmap provides a structured overview of the key requirements for high-risk AI systems under the AI Act. It shows which requirements have to be met in addition to those in the Medical Device Regulation and how the two sets of requirements are interlinked.
The roadmap is not, however, a substitute for a case-by-case evaluation. Providers of AI-based medical devices are still responsible for assessing and implementing the relevant requirements for their individual use cases.
Key findings from cooperation with start-ups
The roadmap is based on the pilot project for the simulation of an AI regulatory sandbox, for which two start-ups, avisé labs GmbH and Katulu GmbH, provided specific use cases. The simulation with these use cases took place under the regulatory supervision of the three partner authorities.
AI regulatory sandboxes enable new technologies to be tested in real-world conditions and at the same time gain important findings for practical implementation. This creates legal certainty beyond the individual case and scales innovation. This especially benefits start-ups and small and medium-sized enterprises, which often lack the financial and personnel resources for comprehensive compliance tasks.
Further information and publication of the roadmap
The roadmap (in German), the final report on the simulated AI regulatory sandbox process and additional information on the AI regulatory sandbox can be found on the AI Service Desk web pages (www.bundesnetzagentur.de/ki-reallabor).