1、目的


                                                                                                                    


規(guī)范臨床資料的匯編整理工作、滿足醫(yī)療器械指令的要求。      


                                                                                                                              


2、范圍


                                                                                                                                          


本程序規(guī)定對臨床資料進行匯編的職責、工作程序、內(nèi)容和要求。 


                                                                                                                              


本程序適用于采用CE標志有關產(chǎn)品的臨床調(diào)查及資料匯編/整理工作。


                                                                                                                                               


3、職責


                                                                                                                                          


3.1技術部負責制定臨床資料匯編工作規(guī)范并實施監(jiān)督管理。


                                                                                                                                                            


3.2技術部負責臨床調(diào)查的組織及資料的匯編/整理工作。


                                                                                                                                                            


4、控制程序


                                                                                                                                          


4.1根據(jù)產(chǎn)品的預期用途按MDD93/42/EEC的分類規(guī)則，對產(chǎn)品進行分類。


                                                                                                                                                            


4.2臨床調(diào)查資料


                                                                                                                                                            


4.2.1 下列情況需要臨床調(diào)查：                                                                                                                                                         


a)完全新的器械——部件，特性，作用方式都是不可知的。                                                                                                                                  


b)對現(xiàn)有器械作了修改可能明顯地影響了安全和性能。                                                                                                                                      


c)現(xiàn)有器材用于新的適應癥。                                                                                                                                           


d)新材料與身體接觸。


                                                                                                                                                                                           


4.2.2 在嚴格評估臨床調(diào)查期間所收集資料的基礎上形成臨床報告。其內(nèi)容應包括：


a)器械的預期用途。                                                                                                                                         


b)達到預期用途采用的技術。                                                                                                                                           


c)器械的臨床效果，副作用。                                                                                                                                           


d)使用該器械治療對患者的益處和可能的危害。


e)降低危害的可能措施。                                                                                                                                               


f)臨床調(diào)查參加對象的相關信息等。


                                                                                                                                  


4.3臨床文獻匯編   


                                                                                                                                                  


4.3.1 如果通過對目前可獲得的臨床文獻（有關的科學文獻/臨床資料等）進行收集/整理，


用以證明其符合醫(yī)療器械指令要求，則應形成臨床文獻匯編資料。其內(nèi)容應包括：



 


                                                     

a)器械的預期用途。                                                                                                                                


b)達到預期用途采用的技術。                                                                                                                                           


c)器械的臨床效果，副作用。                                                                                                                                           


d)使用該器械治療對患者的益處和可能的危害。                                                                                                                                            


e)降低危害的可能措施。                                                                                                                                               


f)對相關臨床文獻的評價報告。                                                                                                                                         


g)引用文獻的目錄。



 


4.3.2 臨床資料文獻匯編的要求：                                                                                                                                                    


a）應涉及到臨床風險分析中確定的危害性；                                                                                                                                               


b）引用已出版的文獻時，這種文獻應發(fā)表在得到公認的科技出版物上。                                                                                                                            


c）有關臨床試驗數(shù)據(jù)，包括體外試驗或動物試驗的結果、技術成果符合性鑒定資料、市場信


息方面的文件和記錄，也可作為文獻的一部分。                                                                                                                                         


d）相關領域中的專家意見也可用來證明器械的安全和性能。                                                                                                                                 


e）引用專家的書面意見應有作者簽名并注明日期和身份。  


                                                                                                                        


5、相關文件


                                                                                                                                          


5.1 MDD93/42/EEC附錄IX的分類方法。


                                                                                                                                                                                                                                                                                                          


6、相關記錄


                                                                                                                                          


6.1臨床報告QP32-01