07.01.2025
With the AI Act coming into force on August 1, 2024, the medical technology industry in particular is facing further challenges and many companies lack an overview. Two new publications show how the AI Act can be implemented in a compliant manner and what levers, problems and solutions there are: The Bavarian Medical Technology Cluster and BAIOSPHERE provide support with a position paper and practical guide for the development, approval and handling of artificial intelligence (AI) components in medical devices.
The Bavarian Medical Technology Cluster, operated by Bayern Innovativ GmbH and Medical Valley EMN e.V., and the Bavarian AI agency BAIOSPHERE are publishing a position paper and a practical guide on the AI regulation of AI components in medical devices.
The rapid development of artificial intelligence opens up enormous opportunities for medical technology. At the same time, its integration into medical products presents manufacturers, operators and healthcare facilities with complex regulatory and practical challenges. A guide is needed. With the publication of the position paper and the practical guide, the project "AI Meets Medtech" by the project partners Bayern Innovativ GmbH, Medical Valley EMN e.V. and the Bavarian AI agency BAIOSPHERE creates well-founded orientation aids for companies and institutions in the industry. Both documents were presented to Bavarian politicians in Munich on November 28, 2024, represented by Tobias Gotthardt, Secretary of Economic Affairs, and are now available to the public free of charge.
The position paper analyzes the key challenges arising from the combination of the EU AI Act with the existing Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). It shows how regulatory requirements influence innovation processes and offers concrete solutions for successfully overcoming these requirements. Unclear definitions, barriers to innovation and difficult translation are just three of the many challenges that need to be solved for a concrete approach.
The practical guide is aimed specifically at small and medium-sized enterprises (SMEs). It describes practical steps for developing and approving AI components in medical products in a legally compliant manner. This provides SMEs with valuable insights into the approval process and guidance on implementing regulatory requirements.
Julia Ott, Cluster Manager Medical Technology, Bayern Innovativ GmbH, emphasizes: "With these publications, we are helping to draw attention to the hurdles associated with the AI Act - at the same time, we are offering the medical technology industry in Bavaria and beyond guidance on the requirements of the AI Act and how to deal with them in a compliant manner."
The publications were developed as part of the cross-cluster project "AI Meets Medtech" together with experts from science, application and industry. The project was funded by the Bavarian State Ministry of Economic Affairs, Regional Development and Energy in order to support companies in Bavaria and strengthen their innovative power. The publications are available to download free of charge.
