Computational Regulation of Medical Devices in PSOA RuleML.

The registration and marketability of medical devices in Europe is governed by the Regulation (EU) 2017/745 and by guidelines published in terms thereof. This work focuses on formalizing the rules for risk-based classification of medical devices as well as the conformity assessment options for each class in Positional-Slotted Object-Applicative (PSOA) RuleML. We tested this open-source knowledge base by querying it in the open-source PSOATransRun system. The aim of this formalization is to create a computational guideline to assist stakeholders.