Chinese Journal of Pharmacovigilance ›› 2022, Vol. 19 ›› Issue (1): 79-82.
DOI: 10.19803/j.1672-8629.2022.01.17

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Methods for risk trend analysis of EU post-marketing surveillance for medical devices

ZHENG Chao1, WU Yan1, ZHANG Lan1, HU Kai1, ZENG Ye1, WANG Wen1,*, WANG Ling2   

  1. 1Zhejiang Center For Medical Device Evaluation (Zhejiang Center For Medical Device Adverse Events Monitoring), Hangzhou Zhejiang 311121, China;
    2Center For Drug Reevaluation, NMPA/NMPA, Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China
  • Received:2021-04-28 Online:2022-01-15 Published:2022-01-20

Abstract: Objective To improve the level of risk management based on a study of statistical methods for post-marketing risk assessment of medical devices. Methods The applications of trend analysis methods for post-marketing risk assessment of medical devices were explored by reference to the trend reporting requirements in the new EU medical device regulations. The process of determining the control limits and continuous trend monitoring via historical data was analyzed by examples, and related problems were discussed. Results Trend analysis was one of the methods for scientifically evaluating the risks of post-marketing medical devices, and it could be implemented in China. Conclusion Manufacturers can use real-world risk data to carry out trend analysis and improve the ability to warn against post-marketing risks.

Key words: medical devices, trend analysis, risk assessment, control chart, EU

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