附录7制造商趋势报告表.doc

10.7 ANNEX 7- MANUFACTURERS TREND REPORT FORMReport FormManufacturers Trend ReportMedical 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FaxE-mail国家Country4. 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FaxE-mail国家Country5. 报告提交者信息（如果不同于第3、4节）Submitters information (if different from section 3 or 4)提交者姓名Submitters name 联系人姓名Contact name地址Address 邮编Postcode城市City电话Phone传真FaxE-mail国家Country6. 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 IVD 附件列表A IVD Annex List A MDD法规规定第b类 MDD Class b IVD 附件列表B IVD Annex List B MDD分类 a MDD Class a IVD自测诊断器械 IVD Devices for self-testingMDD分类 MDD Class 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 number(s)序列(适用时)号Serial number range (if applicable)批号Lot/batch number range(if applicable)软件版本号(适用时) Software version number (if applicable)附件/随附器械(适用时) Accessories / associated devices (if applicable)公告机构识别号码Notified Body (NB) ID Number 7.趋势报告信息Information on Trend Report确定趋势日期Date the trend was identified描述称述的确定趋势Description narrative for identified trend趋势分析时间段Time period of trend analysis建立调节触发Established trigger level是否在警戒情况下作为可报告的事件单独递交？Have any of the trended events been submitted individually as reportable events under vigilance? 是Yes 否No如果是，请列出数量和提交给了哪些国家主管部门If yes, please list how many and to which Competent Authority8. 制造商的初步意见Manufacturers preliminary comments制造商对趋势事件的初步分析Manufacturers preliminary analysis into causes of trend制造商最初的纠正/预防措施的实施情况Initial corrective actions / preventive actions implemented by the manufacturer预期下一个报告的时间Expected date of next report9. 制造商的最终调查趋势的结果Results of manufacturers final investigation into trend制造商趋势分析结果The manufacturers trend analysis results补救措施/纠正/预防措施/现场安全纠正措施Remedial action / corrective action / preventive action / Field Safety Corrective Action确定行动实施的时间计划Time scheduled for the implementation of the identified actions制造商最后评价Final comments from the manufacturer未来的调查Further investigation10. 医疗器械被经销至以下国家The medical device has been distributed to the following Countries在EEA,瑞士和土耳其内Within EEA, Switzerland and Turkey: AT BE BG 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 TR候选国家Candidate Countries: HR所有EEA-, 候补国家和瑞士All EEA, Candidate Countries, Switzerland and Turkey其他Others:11. 评价CommentsSubmission of this report does not, in itself, represent 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) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.I affirm that the information give