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.
We thank Dr. Gen Zou (UNB) for realizing PSOATransRun and for his early comments on this work. Moreover, we thank Dr. Vasileios Aravantinos (Council of State of Greece) for his hints on the expressiveness, interpretability and accuracy of Medical Devices Rules.
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