Regulatory Status of the Application of AI Products in Medicine – an overview

Duration: December 2022 until November 2023

The German Standardization Roadmap “Artificial Intelligence” sees a great need for an adaptation of the legal framework, especially with regard to products with artificial intelligence in the field of medicine. In order to be able to make such an adjustment in a system-compliant manner, the current state of regulation of these products must first be examined. Against this background, the ad hoc project Regulatory Status of the Application of AI Products in Medicine will develop an overview of the existing regulatory levels and the subjects of examination that apply there. From this overview, it should be possible to determine the regulatory complexes and their current design for products of the individual classes of medical devices by way of example. The scope of testing in the conformity assessment procedure and regulations governing use, operation and product warnings in the event of identified risks will be examined. Furthermore, the product monitoring obligations and the response obligations for the individual product groups are recorded. This provides a basis for further discussion on the further development of the legal treatment of AI in medicine.

Principal Investigators

Prof. Dr. Wolfgang Voit, Philipps-Universität Marburg | more information»
Prof. Dr. Martin C. Hirsch, Philipps-Universität Marburg | more information»

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