Object-Relational Rules for Medical Devices: Classification and Conformity

摘要

This work focuses on formalizing the rules enacted by Regulation (EU) 2017/745, for risk-based classification and for class-based conformity assessment options regarding medical devices marketability, in Positional-Slotted Object-Applicative (PSOA) RuleML. The knowledge base represents knowledge by integrating F-logic-like frames with Prolog-like relationships for atoms used as facts and in the conditions and conclusions of rules. We tested this open-source knowledge base by querying it in the open-source PSOATransRun system which provided a feedback loop for refinement and extension. This can support the licensing process for stakeholders and the registration of medical devices with a CE conformity mark.