欧盟最新医疗器械指令MEDDEV21121rev6附录中英文Word下载.docx

1、 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

2、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（请表明其身份）Others: （identify the role）3 制造商信

3、息 Manufacturer information制造商名称Manufacturer name制造商联系人Manufacturers 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）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 Representatives contact person5 报告提交者信息（如果

4、不同于第3、4节） Submitters information （if different from section 3 or 4）提交者姓名submitters name联系人姓名Name of the contact person6 医疗器械信息 Medical device information分类Class 有源植入类AIMD Active implants MDD法规规定第类 MDD Class IVD 附件列表A IVD Annex List A MDD法规规定第类 MDD Class b IVD 附件列表B IVD Annex List B MDD分类 a MDD Class

5、 a IVD自测诊断器械 IVD Devices for self-testing MDD分类 MDD Class 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Commercial 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 nu

6、mber（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）公告机构识别号码 Notified Body （NB） ID-number7 事故信息Incident information使用点报告参考号码,适用时User facility report reference number, if applicable制造商知悉日期Manu

7、facturers awareness date事故发生日期Date the incident occurred事故描述Incident description narrative涉及病人数量（若知 ）Number of patients involved （if known）涉及器械数量（若知） Number of medical devices involved （if known）医疗器械现处地点（若知）Medical device current location/disposition（if known）事故发生时医疗器械的使用者Operator of the medical dev

8、ice 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（

9、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 outcome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 applicab

10、le 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 facility10 制造商初始意见（初次/跟踪报告） Manufacturers preliminary comments （Initial/Follow-up report）制造商初始分析Manufacturers preliminary analysis

11、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 manufacturers d

12、evice 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

13、造商末次评估报告Final comments 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如果是,请表明在何国家和事故报告索引号.If yes, stare in which countries a

14、nd the report reference numbers of the incidents.仅对末次报告适用:医疗器械被分布到下列国家内:For Final Report only: The medical device has been distributed to the following countries:-在EEA和瑞士内:-Within the EEA and Switzerland:AT BE BU CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MT NL NO PL PT RO SE SI SK-候补国

15、家-Candidate Countries CR TR所有EEA-, 候补国家和瑞士 ALL EEA-,Candidate Countries and Switzerland -其他:-others:12 评价Comments本人保证就本人所掌握的知识范围,上述信息是正确的。I affirm that the information given above is correct to the best of my knowledge.签名Signature姓名Name：城市City:日期Date:Submission of this report does not, in itself, re

16、present a conclusion by the manufacturer and/or authorized representative or the National Competent Authority that the content of this report is complete or accurate, that the medical device（S） caused or contributed to the alleged death or deterioration the state of the health of any person.本报告的提交本身

17、并不代表制造商和或其授权代表或国家主管当局对本报告的内容完整或准确的结论，也不代表所列医疗器械的任何错误和或医疗器械引起或促成了宣称的任何人的死亡或其健康六况的严重损坏。附录4 欧洲市场安全纠正措施ANNEX 4 EUROPEAN FIELD SAFETY CORRECTIVE ACTION REPORT FORM（MEDDEV 2.12/1 rev 5）送达地Destination制造商指定索引号Reference number assigned by the manufacturer事故索引号及协作国家主管当局名称（适用时）Incident reference number and nam

18、e of the co-ordinating NCA Competent Authority （if applicable）确定该报告的其它发送国家主管当局Identify to what other Competent Authorities this report was also sent EEA内授权代表 Authorised Representative within EEA5 国家联络点信息 National contact point information国家联络点名称 National contact point name序列号/批号Serial number（s） or l

19、ot/batch number（s） 制造日期/失效期Device Manufacturing date/Expiry date7 市场安全纠正措施描述Description of FSCA市场安全纠正措施背景信息和原因Background information and reason for the FSCA描述措施及其理由（纠正/预防）Description and justification of the action （corrective/preventive）分销商和使用者对所采取措施的建议Advice on actions to be taken by the distribut

20、or and the user.附加资料Attached please find 英文版市场安全公告Field Safety Notice （FSN） in English 国语版市场安全公告FSN in national language 其它（请详述）Others （please specify） 在EEA和瑞士内受市场安全纠正措施影响的国家： These countries within the EEA and Switzerland are affected by this FSCA:- 在EEA和瑞士内 - within the EEA and SwitzerlandEEA和瑞士范围之外受市场纠正措施影响的国家These countries outside the EEA and Switzerland are affected by this FSCA:8 备注Comments日期Date