Computational Argumentation for Medical Device Regulatory Classification

Abstract

This work implements argumentation as the basis for modeling the relevant EU legislation concerning medical devices classification. Stakeholders can consult a web application for determining the risk-based class of a medical device based on the relevant legislation. The described approach is generally applicable to any other analogous cases of decision-making based on legislative regulations. One of the main advantages of using argumentation is the explainability and the high modularity of software permitting the extension and/or modification of the code when new relevant regulations become available.