1、目的


                                                                                                                                          


根據(jù)歐盟醫(yī)療器械指令要求，為公司法人和其在歐盟的代表履行向社會承諾，所實施的質(zhì)量體系和所生產(chǎn)的帶有CE標志的醫(yī)療器械產(chǎn)品符合歐洲協(xié)調(diào)標準和相關法令，并接受歐盟的監(jiān)督。


                                                                                                                                               


2、范圍


                                                                                                                                          


本程序規(guī)定了編寫符合性聲明陳述文件的職責、工作程序、內(nèi)容和要求。


                                                                                                                                               


本程序適用于本公司建立的質(zhì)量體系及所覆蓋的CE標記產(chǎn)品。


                                                                                                                                               


3、職責


                                                                                                                                          


3.1技術(shù)部負責編制符合性聲明的書面陳述文件。


                                                                                                                                                            


3.2公司總經(jīng)理負責實施并簽署符合性聲明。


                                                                                                                                                            


4、控制程序


                                                                                                                                          


4.1符合性聲明陳述文件應包括以下內(nèi)容：                                                                                                                                                


a)文件標題；                                                                                                                                               


b)公司名稱、地址及歐盟代表的名稱和郵政地址；                                                                                                                                          


c)產(chǎn)品名稱、型號及分類號；                                                                                                                                           


d)產(chǎn)品的概況說明和使用方法；                                                                                                                                         


e)產(chǎn)品滿足MDD要求及符合進口商或歐盟代表所在國的標準編號。


f)適用的質(zhì)量保證體系和產(chǎn)品及技術(shù)文檔，符合MDD93/42/EEC的有關描述。                                                                                                                         


g)發(fā)布符合性聲明陳述文件的地點和日期。                                                                                                                                                


h)授權(quán)發(fā)布人的姓名、職務和簽字。



 


4.2公司總經(jīng)理負責確認列入符合性聲明的產(chǎn)品滿足MDD93/42/EEC的要求，并經(jīng)公告機構(gòu)認


證，正式簽署符合性聲明。


                                                                                                                                            


4.3技術(shù)部根據(jù)MDD93/42/EEC的要求，編制符合性聲明陳述文件，應將經(jīng)公告機構(gòu)認證的產(chǎn)品


列入符合性聲明文件之中。


                                                                                                                                            


4.4符合性聲明陳述文件的保存。


                                                                                                                                                            


4.4.1 符合性聲明陳述文件連同技術(shù)文件分別保存于本公司及歐盟授權(quán)代表處。



 


4.4.2 文件的保存期限，從最后一批產(chǎn)品的制造日期計，至少五年。以備國家主管當局檢查。


                                                                                                                                            


                                                                         

                                                                                                                                    


5、相關文件



 


5.1醫(yī)療器械指令  MDD93/42/EEC 附錄V、VII；


                                                                                                                                                            


5.2CE技術(shù)文檔；


                                                                                                                                                                     


                                                                                                                                                  


6、相關記錄     


                                                                                                                                  


6.1符合性聲明QP30-01       


                                                                                                                                                  


6.2文件發(fā)放、回收記錄QP01-02