Preparing the certification of software as a medical device: a european regulatory analysis and case study on the Clynx®Platform

Abstract Purpose: The primary objective of this study is the preparation of the certification of the Clynx® Platform, a physiotherapy software, as a Class IIa medical device software in accordance with the regulatory framework outlined in Medical Device Regulation 2017/745 (MDR). Methods: The methodology involves a comprehensive analysis of European Union medical device regulations and guidelines, with a specific focus on the certification process essential for obtaining a Conformité Européenne (CE) marking for Class IIa medical device software. This section explores the intricate aspects of the certification process, emphasizing the compilation of Technical Documentation, the nuances of Clinical Evaluation, and the establishment of a Quality Management System. The approach aligns closely with the stipulations of MDR 2017/745. Results: The study includes an industry case study featuring the Clynx® Platform, developed by Clynx® Health. Insights derived from the MDR are applied to categorize an in-development version of the software as a Class IIa medical device. The preparation of certification of this product involves the meticulous creation of Intended Use, Classification, General and Safety Performance Requirements, and Clinical Evaluation files, the presentation of an experimental protocol to validate the software’s technical performance for inclusion in the Clinical Evaluation, and a description of an Internal Audit performed on the Quality Management System. Conclusion: The certification of Class IIa medical device software necessitates the compilation of thorough Technical Documentation, including an extensive Clinical Evaluation, and the implementation of a robust Quality Management System. The certification process is conducted in collaboration with Notified Bodies, ensuring adherence to the stringent requirements set forth by the regulatory framework.