| Summary: | This article introduces a novel approach to digitize legislation using rule based-decision trees (RBDTs). As regulation is one of the major barriers to innovation, novel methods for helping stakeholders better understand, and conform to, legislation are becoming increasingly important. Newly introduced medical device regulation has resulted in an increased complexity of regulatory strategy for manufacturers, and the pressure on notified body resources to support this process is making this an increasing concern in industry. This paper explores a real-world classification problem that arises for medical device manufacturers when they want to be certified according to the In Vitro Diagnostic Regulation (IVDR). A modification to an existing RBDT algorithm is introduced (RBDT-1C) and a case study demonstrates how this method can be applied. The RBDT-1C algorithm is used to design a decision tree to classify IVD devices according to their risk-based classes: Class A, Class B, Class C and Class D. The applied RBDT-1C algorithm demonstrated accurate classification in-line with published ground-truth data. This approach should enable users to better understand the legislation, has informed policy makers about potential areas for future guidance, and allowed for the identification of errors in the regulations that have already been recognized and amended by the European Commission.
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