The Analysis of Problems and Preliminary Exploration of Countermeasures in Periodic Risk Evaluation Report for Medical Devices
The Periodic Risk Assessment Report(PRER)for medical devices is of great significance for the safety research of products after the products launch.In this study,by sorting and summarizing the PRERs submitted by registered individuals in Shandong Province within the National Medical Device Adverse Event Monitoring Information System,and combining with grassroots research and actual work,the existing problems of PRERs were summarized,and innovative measures to strengthen regular risk assessment of medical devices were explored to ensure the implementation of corporate main responsibilities.