2024年3月16日发(作者：)

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 6）

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

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（若已知）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

主管当局盖章Stamp box for the

Competent Authority (～60

×

40 mm)

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

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

电话Phone

电子邮件E-mail

城市City

传真Fax

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

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Name of the contact person

地址Address

邮政编码 Postal code

电话Phone

城市City

传真Fax