附录7制造商趋势报告表.doc

10.7 ANNEX 7- MANUFACTURER’S TREND REPORT FORM Report Form Manufacturer’s Trend Report Medical Devices Vigilance System (MEDDEV 2.12/1 rev 8) 附录7 制造商趋势报告表 医疗器械警戒系统体系 V.01.13 1. 行政信息Administration Information 接受者（国家主管当局名称）Recipient (Name of National Competent Authority NCA) 国家主管当局地址Address of National Competent Authority 报告日期Date of this report 制造商指定的参考号码Reference number assigned by the manufacturer 国家主管当局指定的接收者索引号码Reference number assigned by NCA 报告类型Type of report 趋势初始Trend Initial 趋势跟踪Trend Follow up 趋势最终Trend Final 事件是否构成严重危害公众健康Do these incidents / trend represent a serious public health threat? 是Yes 否No 确定该报告的其他发送国家主管当局Identify to what other NCAs this report was also sent 2. 报告提交人信息Information on submitter of the report 发送人身份Status of submitter 制造商Manufacturer EEA ,瑞士和土耳其内授权代表Authorised Representative within EEA, Switzerland and Turkey 其他（请表明其身份）Others: (identify the role) : 3.制造商信息 Manufacturer information 制造商名称Name 联系人姓名Contact name 地址Address 邮编Postcode 城市City 电话Phone 传真Fax E-mail 国家Country 4. 授权代表信息Authorised Representative information 授权代表名称Name 授权代表联系人Contact name 地址Address 邮编Postcode 城市City 电话Phone 传真Fax E-mail 国家Country 5. 报告提交者信息（如果不同于第3、4节）Submitter’s information (if different from section 3 or 4) 提交者姓名Submitter’s name 联系人姓名Contact name 地址Address 邮编Postcode 城市City 电话Phone 传真Fax E-mail 国家Country 6. 医疗器械信息Medical Device Information 分类Class 有源植入类AIMD Active implants MDD法规规定第III类 MDD Class Ш □ IVD 附件Ⅱ列表A IVD AnnexⅡ List A MDD法规规定第Ⅱb类 MDD Class Ⅱb □ IVD 附件Ⅱ列表B IVD AnnexⅡ List B MDD分类 Ⅱa MDD Class Ⅱa □ IVD自测诊断器械 IVD Devices for self-testing □MDD分类 MDD ClassⅠ □ IVD一般 IVDGeneral 分类系统(最好是GMDN) Nomenclature system (preferable GMDN) 分类系统代号Nomenclature code 分类内容Nomenclature text 商品名/品牌名/制造者Commercial name/ brand name / make 型号或者姓Model number(s) or Family name 编号Catalogue