REN YIJUN | Cycle: XXXVII |
Advisor: CAIANI ENRICO GIANLUCA
Tutor: VANTINI SIMONE
Major Research topic:
Natural Language Processing for Regulatory Science: Aggregating Field Safety Notices to Support Post-Market Surveillance of Medical Devices
Abstract:
The European Union Medical Device Regulation (MDR) 2017/745, in force since May 26th, 2021, defines new rules for medical device (MD) certification and post-market surveillance (PMS). The MDR introduces more rigorous procedures for high-risk implantable MD: notified bodies are obliged to consult Expert Panels that could decide to proceed for an extensive review of the supporting clinical evidence submitted by manufacturers, the Clinical Evaluation Consultation Procedure (CECP). The work aims at developing IT tools and methods to automatically collect and display in an aggregated way globally available curated regulatory information on alerts and recalls of high-risk medical devices from the official websites of European competent authorities as well as of non-European regulatory authorities with country-specific approaches, in order to capture possible trends in reported incidents that could be used not only for scientific analysis but also to provide information to Expert Panels for assessment of the need for CECP. Firstly, notices of failure and list of all MDs are retrieved from government websites using Web Scraping if they are available, and they constitute our Dataset of Notices and Dataset of Devices. Then data cleaning and transformation are applied to both datasets followed by the entity resolution technique to allow matching items in the two datasets. A mash up is then performed to integrate data, and to present it to the final user through a graphical interface. The analysis was first focused on the Italian market where all needed information are publicly available and periodically updated. Moreover, the adopted nomenclature, the Italian “Classificazione Nazionale Dispositivi Medici”, was selected as the basis for the European Medical Device Nomenclature (EMDN) in March 2019. Then the similar procedure is applied to Portugal, France, and Greece. However, different from Italian scenario where the work is successfully completed, we have encountered to some challenges to be solved such as unavailability of the needed information, nomenclature mapping missing and manufacturers or devices with different names in different countries.
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