Current regulatory issues of AI in the field of medical technology

Abstract

This paper describes current issues regarding regulatory requirements in medical devices with a focus on data-driven / AI based approaches. It shows that the EU Medical Device Regulation (MDR) sets high requirements to assess product performance based on systematically collected data, whereas the collection of data is difficult in the EU. Contrary, it demonstrates that the FDA is currently very active in supporting the development of software based systems in the US with dedicated regulatory programs. In particular, it pursues more dynamic approaches for releasing software devices. The overall situation favors developments in the US. Thus, the paper surveys a program to support local entities on adapting AI technologies.