Risk-based evaluation of machine learning-based classification methods used for medical devices

In summary, we demonstrated the necessity of a risk-based approach for the evaluation of medical devices which include ML-based classification methods. We showed that currently many scientific papers in this area do not include risk considerations. We developed basic steps towards a risk-based assessment of ML-based classifiers and elaborated consequences that could occur, when these steps are neglected. And, we demonstrated the consistency of our approach with current regulatory requirements in the EU.