欧盟最新医疗器械指令MEDDEV21.121rev6附录中英文.doc

word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 NATIONALPETENT AUTHORITYManufacturer’s Incident Report制造商事故报告医疗器械警戒系统〔MEDDEV 2.12/1 rev 6〕1 行政信息 Administrative information接收者Recipient国家主管当局名称Name of National petent Authority(NCA)国家主管当局地址Address of National petent Authority主管当局盖章Stamp box for the petent Authority (～60×40 mm)该报告的时间Date of this report制造商指定的参考Reference number assigned by the manufacturer国家主管当局指定的接收者索引〔假如〕Reference number assigned by NCA to whom sent (if known)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bined 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NoClassification 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 sent2 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〔请明确其身份〕Others: (identify the role)3 制造商信息 Manufacturer information制造商名称Manufacturer name制造商联系人Manufacturer’s contact person地址Address邮政编码 Postal code城市CityPhone Fax电子国家Country 2)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CityPhone Fax电子国家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)提交者某某submitter’s name联系人某某Name of the contact person地址Address邮政编码 Postal code城市CityPhone Fax电子国家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□IVD一般 IVD General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mercial name/brand name/make型号 Mode and/or编号 catalogue number序列(适用时)号Serial number(s) 〔if applicable〕批号 lot/batch number(s)软件版本号(适用时) Software version number (if applicable)制造日期 Device Manufacturing date, 失效期Expiry date附件/随附器械(适用时) Accessories/associated device (if applicable)公告机构识别 Notified Body (NB) ID-number7 事故信息Incident information使用点报告参考,适用时User facility report reference number, if applicable制造商知悉日期Manufacturers awareness date事故发生日期Date the incident occurred事故描述Incident description narrative涉与病人数量(假如知 )Number of patients involved (if known)涉与器械数量(假如知) Number of medical devices involved (if known)医疗器械现处地点(假如知)Medical device current location/disposition(if known)事故发生时医疗器械的使用者Operator of the medical device at the time of incident(select one)□ 健康护理专家health care professional □ 病人patient□ 其他other医疗器械的使用者(请选择)Usage of the medical device (select from list below)□ 初次使用initial use □一次性器械的重复使用reuse of a single use medical device□ 可重复使用器械的再次使用reuse of a reusable medical device□ 修复后使用/维修 re-serviced/refurbished□ 其他(请详述)other(please specify)□ 使用前注意到问题problem noted prior use8病人信息Patient information事故发生后病人状况patient oute有关的健康护理点采取的补救措施Remedial action taken by the healthcare facility relevant to the care of the patient事故发生时病人的年龄,适用时Age of the patient at the time of incident, if applicable性别,适用时Gender, if applicable□ 女性Female □ 男性Male重量,适用时Weight in kilograms, if applicable9 健康护理点信息Healthcare facility information健康护理点名称Name of the health care facility护理点内联系人Contact person within the facility地址Address邮政编码 Postal code城市CityPhone Fax电子国家Country 2)10 制造商初始意见(初次/跟踪报告) Manufacturer’s preliminary ments (Initial/Follow-up report)制造商初始分析Manufacturer’s preliminary analysis制造商采取的初始纠正预防措施Initial corrective actions/preventive actions implemented by the manufacturer下次预计报告日期Expected date of next report11 制造商末次调查结果(末次报告) Results of manufacturers final investigation (Final report)制造商器械分析结果Results of manufacturers final investigation(Final report)制造商器械分析结果The manufacturer’s device analysis results补救措施/纠正措施/预防措施/市场安全纠正措施Remedial action/corrective action/preventive action/Field safety Corrective Action注意：NOTE: 提交这个市场安全纠正措施需要填附表4 In the case of a FSCA the submitter needs to fill in the form of Annex 4确定采取的措施时间表Time schedule for the implementation of the identified actions制造商末次评估报告Final ments from the manufacturer进一步调查Further investigations制造商有无意识到同型器械中因同类原因造成的同类事故?Is the manufacturer aware of similar incidents with this type of medical device with a similar root cause?□ 是Yes □ 否No类似事件的数量Number of similar incidents。