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(huì)承諾，所實(shí)施的質(zhì)量體系和所生產(chǎn)的帶有CE標(biāo)志的醫(yī)療器械產(chǎn)品符合歐洲協(xié)調(diào)標(biāo)準(zhǔn)和相關(guān)法令，并接受歐盟的監(jiān)督。


                                                                                                                                               


2、范圍


                                                                                                                                          


本程序規(guī)定了編寫(xiě)符合性聲明陳述文件的職責(zé)、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(biāo)記產(chǎn)品。


                                                                                                                                               


3、職責(zé)


                                                                                                                                          


3.1技術(shù)部負(fù)責(zé)編制符合性聲明的書(shū)面陳述文件。


                                                                                                                                                            


3.2公司總經(jīng)理負(fù)責(zé)實(shí)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(yīng)包括以下內(nèi)容：                                                                                                                                                


a)文件標(biāo)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(hào)及分類號(hào)；                                                                                                                                           


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


e)產(chǎn)品滿足MDD要求及符合進(jìn)口商或歐盟代表所在國(guó)的標(biāo)準(zhǔn)編號(hào)。


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(guān)描述。                                                                                                                         


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


h)授權(quán)發(fā)布人的姓名、職務(wù)和簽字。



 


4.2公司總經(jīng)理負(fù)責(zé)確認(rèn)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(jī)構(gòu)認(rèn)


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(yīng)將經(jīng)公告機(jī)構(gòu)認(rèn)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(jì)，至少五年。以備國(guó)家主管當(dāng)局檢查。


                                                                                                                                            


                                                                         

                                                                                                                                    


5、相關(guān)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(guān)記錄     


                                                                                                                                  


6.1符合性聲明QP30-01       


                                                                                                                                                  


6.2文件發(fā)放、回收記錄QP01-02