Leveraging natural language processing to aggregate field safety notices of medical devices across the EU

Abstract

Abstract The European Union (EU) Medical Device Regulation and In Vitro Medical Device Regulation have introduced more rigorous regulatory requirements for medical devices, including new rules for post-market surveillance. However, EU market vigilance is limited by the absence of harmonized reporting systems, languages and nomenclatures among Member States. Our aim was to develop a framework based on Natural Language Processing capable of automatically collecting publicly available Field Safety Notices (FSNs) reporting medical device problems by applying web scraping to EU authority websites, to attribute the most suitable device category based on the European Medical Device Nomenclature (EMDN), and to display processed FSNs in an aggregated way to allow multiple queries. 65,036 FSNs published up to 31/12/2023 were retrieved from 16 EU countries, of which 40,212 (61.83%) were successfully assigned the proper EMDN. The framework’s performance was successfully tested, with accuracies ranging from 87.34% to 98.71% for EMDN level 1 and from 64.15% to 85.71% even for level 4.