Global trends in post-market surveillance of high-risk medical devices: An empirical analysis based on regulatory data

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Analysis highlights trends in post-market surveillance and effectiveness of FSCAs in mitigating risks of high-risk medical devices.

Field safety corrective actions significantly reduced recurrence rates, indicating their importance in managing high-risk medical devices.
Orthopaedic implants and infusion pumps reported the highest incidents, primarily due to hardware failures and software issues.
The study utilized data from EUDAMED and other databases to conduct a thorough quantitative analysis of post-market incidents.
Enhanced regulatory frameworks are needed to better manage the persistent issues of software-driven medical devices.

Manimuthukumar et al. (2025) studied this question.

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