4.12.3歐盟授權代表應做的工作：                                                                                                                                                       


a）歐盟授權代表應負責將制造商帶有CE標志的產品向其所在國主管當局注冊。


b）應保存制造商每類獲得CE標志產品的技術文檔，保存期限至最后一批產品出廠后五年。                                                                                                                           


c）應將主管當局、客戶投訴或其它在歐盟境內發生的與CE標志產品有關的任何信息及時通知


制造商。                                                                                                                                                       


d）協助制造商處理醫療器械的有關事故，并向其所在國主管當局報告初始報告、調查結果及最終報告。   



 


5、相關文件


                                                                                                                                          


5.1醫療器械指令MDD93/42/EEC；        



 


                                                                                                                                                  


5.2警戒系統控制程序  YH/QP-31  。    


                                                                                                                                                  


5.3忠告性通知事故報告YH/QP-24


                                                                                                                                                           


6、相關記錄              


                                                                                                                    


6.1初始報告表     


                                                                                                                                                  


6.2最終報告表     


                                                                                                                                                  


6.3忠告性通知QP24-01       


                                                                                                                                                  


6.4歐盟主管當局一覽表QP31-01