医疗器械警戒系统指南(MEDDEV第8版) 附录3和4_中英文.doc

附件3 制造商向国家主管当局提交报告格式表 ANNEX 3 REPORT FORM FOR MANUFACTURER’S TO THE NATIONAL COMPETENT AUTHORITY Manufacturer’s Incident Report 制造商事故报告 医疗器械警戒系统 （MEDDEV 2.12/1 rev 8） 1 行政信息 Administrative information 接收者Recipient 国家主管当局名称Name of National Competent Authority(NCA) 国家主管当局地址Address of National competent Authority 主管当局盖章Stamp box for the Competent Authority (～60×40 mm 该报告的时间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 初始报告Initial report 跟踪报告Follow-up report 包含初始和最终的联合报告Combined Initial and final report 最终报告Final report 事件是否构成严重危害公众健康Does the incident represent a serious public health threat? □是Yes □否No Classification of incident事故类型 死亡death 健康状况的严重损坏，严重公共健康威胁unanticipated serious deterioration instate of health 其他所有可报告事故ALL other reportable incidents 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 和瑞士内授权代表 Authorised Representative within EEA and Switzerland 其他（请表明其身份）Others: (identify the role) 3 制造商信息 Manufacturer information 名称 Name 制造商联系人 Contact name 地址Address 邮政编码 Postal code 城市City 电话Phone 传真Fax 电子邮件E-mail 国家Country 4 授权代表信息 Authorized Representative information 授权代表名称Name of the Authorized Representative 授权代表联系人The Authorized Representative’s contact person 地址Address 邮政编码 Postal code 城市City 电话Phone 传真Fax 电子邮件E-mail 国家Country 2) 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Name of the contact person 地址Address 邮政编码 Postal code 城市City 电话Phone 传真Fax 电子邮件E-mail 国家Country 2) 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Ш类 MDD Class Ш □ IVD 附件Ⅱ列表A IVD AnnexⅡ List A MDD法规规定第Ⅱ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