Abstract
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.
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Notes
- 1.
PSOA RuleML generalizes F-logic, RIF-BLD, and POSL by a homogeneous integration of relationships and frames into psoa terms.
- 2.
We use the all-upper-case “PSOA” as a reference to the language and the all-lower-case “psoa” for its terms.
- 3.
See also the relevant RuleML wiki page http://wiki.ruleml.org/index.php/PSOA_RuleML.
- 4.
Special cases: Class Is for sterile and Class Im for measuring function.
- 5.
Due to page limitations, the complete code source and queries of the Knowledge Base (KB) can be found in http://psoa.ruleml.org/usecases/MedicalDevices/.
- 6.
Ordered tuple of positional arguments.
- 7.
A unique OID typed by a class and described by an unordered collection of slots.
- 8.
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” [1, Chap. 3 (4.4) (a)]. The present work is restricted to the English version of the Regulation.
- 9.
The medical devices facts are described with their specific characteristics and with their (randomly chosen) completed marketability requirements. The marketable medical devices in each class can be viewed in: http://psoa.ruleml.org/usecases/MedicalDevices/ClassificationAndMarketability.pdf (p. 8).
- 10.
In cases where the codes don’t 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 are used.
- 11.
Due to page limitations, detailed query examples for the Medical Devices Rules and answers from PSOATransRun can be found in http://wiki.ruleml.org/index.php/Medical_Devices_Rules#Formalization_of_Medical_Devices_Rules_in_PSOAhttp://psoa.ruleml.org/usecases/MedicalDevices/.
References
European Parliament: European Parliament. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. Official Journal of the European Union L 117 (2017)
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Acknowledgments
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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Almpani, S., Stefaneas, P., Boley, H., Mitsikas, T., Frangos, P. (2018). Computational Regulation of Medical Devices in PSOA RuleML. In: Benzmüller, C., Ricca, F., Parent, X., Roman, D. (eds) Rules and Reasoning. RuleML+RR 2018. Lecture Notes in Computer Science(), vol 11092. Springer, Cham. https://doi.org/10.1007/978-3-319-99906-7_13
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