ANNEX-6-Mnufacture’s PERIODIC SUMMARY REPORT FORM
REPORT FORM
Manufacture’s Periodic Summary Report(PSR) Medical Devices Vigilance System(MEDDEV 2.1/1 rev 8)
1 行政信息 Administrative information 该报告发送给哪个主管当局？To which NCA(s) is this report being sent? 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 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 电话Phone 电子邮件E-mail 城市City 传真Fax 国家Country 4 授权代表信息 Authorized Representative information 名称Name 联系人contact name 地址Address 邮政编码 Postal code 电话Phone 电子邮件E-mail 城市City 传真Fax 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contact name 地址Address 邮政编码 Postal code 电话Phone 电子邮件E-mail 城市City 传真Fax 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 □ MDD法规规定第Ⅱ类 MDD Class Ⅱb □ MDD分类Ⅱa MDD Class Ⅱa □ MDD分类 MDD ClassⅠ 分类系统(最好是GMDN) Nomenclature system (preferable GMDN) 分类内容Nomenclature text □ IVD 附件Ⅱ列表A IVD AnnexⅡ List A □IVD 附件Ⅱ列表B IVD AnnexⅡ List B □IVD自测诊断器械 IVD Devices for self-testing □IVD一般 IVD General 分类系统代号Nomenclature code 公告机构识别号码 Notified Body (NB) ID-number 型号 Mode number(s)/or Family Name 编号 catalogue number(s) 7 PSR信息7 PSR information PSR类型PSR Type □Incidents described in a Field Safety Notice If Incidents described in a Field Safety Notice, Manufacturers reference number for FSN/FSCA Stage of PSR reporting based on: □ Observed Failure mode□Root cause Common and well documented incidents □ Common and well documented incidents Nature of problem agreed for PSR reporting Summary period agreed: □Every month□Every 2 months □Every 3 months □Every 6 months □Every 12 months The figures in the table below relateto: □ EEA+ CH+ TR □All PSR recipients NCA’s □Single Member State identified in Section 1 Please name:- Date of PSR New incidentsTotal numberTotal number inTotal number in
this periodincident via PSR resolvedprogress
8. Manufacturer’s comments / investigation results
Investigation update for this period
Initial corrective actions / preventive actions implemented by the manufacturer
Recommended actions for this period, if any
Expected date of next PSR report
9. Distribution