1、目的


                                                                                                                                          


根據歐盟醫療器械指令要求，為公司法人和其在歐盟的代表履行向社會承諾，所實施的質量體系和所生產的帶有CE標志的醫療器械產品符合歐洲協調標準和相關法令，并接受歐盟的監督。


                                                                                                                                               


2、范圍


                                                                                                                                          


本程序規定了編寫符合性聲明陳述文件的職責、工作程序、內容和要求。


                                                                                                                                               


本程序適用于本公司建立的質量體系及所覆蓋的CE標記產品。


                                                                                                                                               


3、職責


                                                                                                                                          


3.1技術部負責編制符合性聲明的書面陳述文件。


                                                                                                                                                            


3.2公司總經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)產品名稱、型號及分類號；                                                                                                                                           


d)產品的概況說明和使用方法；                                                                                                                                         


e)產品滿足MDD要求及符合進口商或歐盟代表所在國的標準編號。


f)適用的質量保證體系和產品及技術文檔，符合MDD93/42/EEC的有關描述。                                                                                                                         


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


h)授權發布人的姓名、職務和簽字。



 


4.2公司總經理負責確認列入符合性聲明的產品滿足MDD93/42/EEC的要求，并經公告機構認


證，正式簽署符合性聲明。


                                                                                                                                            


4.3技術部根據MDD93/42/EEC的要求，編制符合性聲明陳述文件，應將經公告機構認證的產品


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文件分別保存于本公司及歐盟授權代表處。



 


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


                                                                                                                                            


                                                                         

                                                                                                                                    


5、相關文件



 


5.1醫療器械指令  MDD93/42/EEC 附錄V、VII；


                                                                                                                                                            


5.2CE技術文檔；


                                                                                                                                                                     


                                                                                                                                                  


6、相關記錄     


                                                                                                                                  


6.1符合性聲明QP30-01       


                                                                                                                                                  


6.2文件發放、回收記錄QP01-02