TUV 医疗器械CE技术文件指南.docxVIP

技术文件 请按如下方式使用本附件：请在“页面/章节或NA”列中添加技术文件中文件的详细位置。在“参考证据（文件标题和编号、适用章节、章节等）一栏中，或在不适用的情况下，包括理由”一栏中，请添加适用于所提交技术文件的相应信息。您可以在完成相应部分后使用“核对”。 Ref to MDR Requirement Each column to be completed by customer Page / section or N/A Referenced evidence (Document Title No., Applicable Chapter, Section etc.) Or in case of N/A include justification Check off Application (1) 申请书（1） “Product List and Application MDR (QM part)” (MS-0030360) “产品清单和应用MDR（质量管理部分）”（MS-0030360） and/or “Product list and Application MDR, Technical Documentation assessment, Annex IX, chapter II” (MS- 0030497) 和/或“产品列表和应用MDR，技术文件评估，附件九，第二章”（MS-0030497） or “Product List and Application MDR, Product Verification” (MS-0030499) 或“产品清单和应用MDR，产品验证”（MS-0030499） The following information should be listed on the Product List and Application: 产品清单和应用程序中应列出以下信息： Identification of the legal manufacturer, who is placing the device on the market. This should be consistent across the device labels, IFU and Declaration of Conformity. The Single Registration Number (SRN) of the legal manufacturer should be identified. 将设备投放市场的合法制造商的身份证明。设备标签、IFU和符合性声明应保持一致。应确定合法制造商的单一注册（SRN）。 The name and location of the EU Authorized Representative should be identified if required. Only one EU Representative should be identified, and this should be consistent across device labels, IFU and Declarations of Conformity. The Single Registration Number (SRN) of the EU Authorized Representative should be identified. 如果需要，应确定欧盟授权代表的姓名和位置。应仅确定一名欧盟代表，且应在设备标签、IFU和符合性声明中保持一致。应确定欧盟授权代表的单一注册号（SRN）。 The site(s) responsible for design need to be identified, either external and/or internal. 需要确定负责设计的现场（外部和/或内部）。 All relevant sterilization facilities, internal/external manufacturing facilities, etc., must be listed on your Product List and Application. 所有相关灭菌设施、内部/外部制造设施等必须列在产品清单和应用程序中。 In the column “Product name (as listed on label)” the product names need to be listed as identified on the labels. Please complete all lines of the t