1、目的


                                                                                                                                          


根据欧盟医疗器械指令要求，为公司法人和其在欧盟的代表履行向社会承诺，所实施的质量体系和所生产的带有CE标志的医疗器械产品符合欧洲协调标准和相关法令，并接受欧盟的监督。


                                                                                                                                               


2、范围


                                                                                                                                          


本程序规定了编写符合性声明陈述文件的职责、工作程序、内容和要求。


                                                                                                                                               


本程序适用于本公司建立的质量体系及所覆盖的CE标记产品。


                                                                                                                                               


3、职责


                                                                                                                                          


3.1技术部负责编制符合性声明的书面陈述文件。


                                                                                                                                                            


3.2公司总经理负责实施并签署符合性声明。


                                                                                                                                                            


4、控制程序


                                                                                                                                          


4.1符合性声明陈述文件应包括以下内容：                                                                                                                                                


a)文件标题；                                                                                                                                               


b)公司名称、地址及欧盟代表的名称和邮政地址；                                                                                                                                          


c)产品名称、型号及分类号；                                                                                                                                           


d)产品的概况说明和使用方法；                                                                                                                                         


e)产品满足MDD要求及符合进口商或欧盟代表所在国的标准编号。


f)适用的质量保证体系和产品及技术文档，符合MDD93/42/EEC的有关描述。                                                                                                                         


g)发布符合性声明陈述文件的地点和日期。                                                                                                                                                


h)授权发布人的姓名、职务和签字。



 


4.2公司总经理负责确认列入符合性声明的产品满足MDD93/42/EEC的要求，并经公告机构认


证，正式签署符合性声明。


                                                                                                                                            


4.3技术部根据MDD93/42/EEC的要求，编制符合性声明陈述文件，应将经公告机构认证的产品


列入符合性声明文件之中。


                                                                                                                                            


4.4符合性声明陈述文件的保存。


                                                                                                                                                            


4.4.1 符合性声明陈述文件连同技术文件分别保存于本公司及欧盟授权代表处。



 


4.4.2 文件的保存期限，从最后一批产品的制造日期计，至少五年。以备国家主管当局检查。


                                                                                                                                            


                                                                         

                                                                                                                                    


5、相关文件



 


5.1医疗器械指令  MDD93/42/EEC 附录V、VII；


                                                                                                                                                            


5.2CE技术文档；


                                                                                                                                                                     


                                                                                                                                                  


6、相关记录     


                                                                                                                                  


6.1符合性声明QP30-01       


                                                                                                                                                  


6.2文件发放、回收记录QP01-02