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

Interactive spreadsheet

The tabular overview provides the first comprehensive summary of the regulatory requirements for AI products in medicine and offers an effective way to gain access to the topic. The regulatory status of software medical devices in the Medical Devices Regulation is outlined and compared with the new regulations of the AI Regulation. The table also provides insights into standardisation and reform efforts in the context of data protection, liability and reimbursement by statutory health insurance funds. It can serve as a basis for interdisciplinary exchange and as an overview of the regulatory requirements at the intersection of medical devices and AI.

The interactive Excel table is available for you to view and download here.

Furthermore, you will find below an introduction to the tabular overview and the corresponding supporting literature.

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