5. 医疗器械ce认证(mdd认证)技术文件包含要素:
1. information about manufacturer制造商信息（name and address ofmanufacurer, location and address of manufacture anddesign制造商名称地址，制造设计名称地址）
1.1 decleration of conformity自我宣告
1.2 european representative 欧洲代表
2. information about product产品信息
2.1 product deion,if applicable clear definition of theproduct models and its accessories产品描述；如可能清晰定义产品型号以及其配件
2.2 intended use of product产品使用用途
2.3 product label 产品铭牌
2.4 classification of the product产品分类
2.5 list of standards used使用标准
2.6 essential requirements (annex-1) 基本要求（附录一）
2.7 risk analysis风险分析
2.8 product lifetime产品寿命
3. technical specifications of product产品技术规格型号
3.1 list of components, specifications of used materialsincluding confomity certificates,datasheets ,test about criticalsuppliers.零配件清单，使用材料规格表及材质证明书，测试报告；关键供应商信息等
3.2 technical drawings技术图纸
3.3 deion of product manafacturing, special processes,flowcharts,used records etc.产品制造描述、特定程序、流程图、使用记录等等
3.4 sterilization validation data, packagingspecifications消毒证明数据，包装规格等
3.5 biocompability conformity data生物兼容性评估数据
3.6 product test reports产品测试报告
3.7 software validation 软件有效期
3.8 clinical data 临床报告
