Global trends in post-market surveillance of high-risk medical devices: An empirical analysis based on regulatory data.
PMID: 41100654 · 2025
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Background & objectives To analyse post-market surveillance (PMS) trends for high-risk medical devices (Class IIb and III) in different geographic regions and evaluate the effectiveness of field safety corrective actions (FSCAs) in mitigating device-related risks. Methods This study utilised 2024 data from EUDAMED (European Database on Medical Devices), BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte), and MAUDE (Manufacturer and User Facility Device Experience (FDA database)) to iden
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