Abstract
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.
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- 1.
Details of PSOA RuleML syntax, terms, and PSOATransRun can be found in [5] and in PSOA RuleML wiki page http://wiki.ruleml.org/index.php/PSOA_RuleML.
- 2.
It formalizes the sentence “All non-invasive devices which come into contact with injured skin or mucous membrane are classified as: class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates” [9]. The present work is restricted to the English version of the Regulation.
- 3.
ECA: European Competent Authorities, EAR: European Authorized Representative.
- 4.
The code source and PSOATransRun queries of the KB and detailed explanatory diagrams can be found in: http://psoa.ruleml.org/usecases/MedicalDevices/. See also the wiki page: http://wiki.ruleml.org/index.php/Medical_Devices_Rules.
- 5.
In cases where the codes do not describe specifically a category a random coding is applied (e.g.,:DeviceR3a), while in cases where more than one category belongs in the same code, letters a,b,c,ST are used (e.g., mdcode:MDN1202c).
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Acknowledgments
We want to 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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Almpani, S., Stefaneas, P., Boley, H., Mitsikas, T., Frangos, P. (2018). Object-Relational Rules for Medical Devices: Classification and Conformity. In: Panetto, H., Debruyne, C., Proper, H., Ardagna, C., Roman, D., Meersman, R. (eds) On the Move to Meaningful Internet Systems. OTM 2018 Conferences. OTM 2018. Lecture Notes in Computer Science(), vol 11230. Springer, Cham. https://doi.org/10.1007/978-3-030-02671-4_37
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