(完整word版)无源医疗器械CE技术文档和CE设计档案材料指南(中英文 也是极好的)

无源医疗器械技术文件和设计文档指南

Whereas the term “Technical File“ is used for Medical Devices of class I, class IIa and class IIb, the term “Design Dossier“ is used for the class III products.

标题中的“技术文件”适用于I类，IIa类,IIb类医疗器械，“设计文档”适用于III类医疗器械。

Technical Files are retained in the premises of the manufacturer or the Authorized Representative for potential review of Competent Authorities and Notified Body.

Part B of the Technical File may be available at the manufacturer only.

技术文件是保留在制造商或授权代表单位的主管部门和认证机构。部分技术文件B部分只保留在制造商处。

Whereas Design Dossiers have to be submitted to the Notified Body for review prior to CE-Marking of the product (use form Application for CE Conformity Assessment (Product)MED_F_03.03). We will assign a project manager who will entrust one or more further experts with the review of particular modules. All experts are at your disposal directly or indirectly through the project manager. After successful review, the Notified Body issues a design examination certificate according to Annex II.4 of the Council Directive certifying compliance with the relevant provisions of Annex I of the MDD.

设计档案材料已被提交到公告机构用于需要CE认证前的产品审查（用CE合格评定（产品）MED_F_03.03规定的格式）。我们将委派一个项目经理，他将委托一个或多个资深专家审查特定的模块。所有专家会直接或通过项目经理间接与你接触，在成功的审查后，公告机构会按照MDD法规附件I和附件II.4相关规定签发检验证书。

Article 5 of the Council Directive describes consideration of the European harmonized standards by the manufacturer in order to demonstrate compliance with the Essential Requirements.This aspect is even more important as International Standard Organizations have adopted European Norms (and vice versa) and demonstrating compliance with these standards could be very helpful in international mutual recognition of the CE-Marking process.

理事会指令5描述了制造商要遵守的欧洲统一标准，以证明附合基本要求，这方面更重要的是为国际标准组织已经通过了欧洲规范（反之亦然），并且遵守这些标准可能非常有助于国际的相互承认在CE认证过程中。

It is not necessary to include all documents in the Design Dossier which have already been subject to an ISO / EN / MDD Audit by the Notified Body. Examples of documents not necessary to be included are Quality Manuals and related lower level documents.

设计档案材料不必一定包括那些已经提交给ISO / EN / MDD审查公告机构的所有的文档，例如文档不必包括质量手册和一些相关更下层文档。

If the manufacturer of a class III device provides detailed information according to the checklist described below, the requirements of the Directive are appropriately addressed.

如果一个类III器件制造商提供详细的资料按下述清单，该指令的要求得到适当处理This is even more important in case a Competent Authority or another Notified Body

wishes to review the documentation.

这样很重要如果主管部门或其他认证机构要审查文件

Generally, the information should be provided as conclusions, summaries, reports, tables or flow charts (with reference to the full documentation in the Essential Requirement checklist).

一般的，提供的信息应包括结论，摘要，报告，表或流程图（参照完整文档在基本要求检查表中）

Special care should be taken to ensure that any information is consistent throughout the Design Dossier (e.g. description and variants of the device in different documents; adverse events as stated in the IFU and hazards in normal condition as well as in fault condition in the Risk Management).

特别应注意确保任何信息在整个卷中是一致的（例如：在不同的文档中器械的规格描述；说明书中不良事件的声明和在正常情况下的危害，以及在故障情况下的风险管理）

A complete pagination of the Design Dossier or another type of control mechanism is necessary, e.g. revision control of each section. Two copies of the documentation and an electronic version, if possible are required to achieve an appropriate review time. 设计档案材料必须有完整的页码控制或者另外形式的控制机制，例如，每个章节的版本控制。两份拷贝和一个电子版本，如果可能还需要一个审查时间。

In general, design changes described in the MDD (93/42/EEC), Annex II.4.4 shall be reported to the Notified Body (use form Change Notification MED_F_09.04) in order to ensure conformity with the requirements defined in the Annex II.4.4 and in order to ensure that the Design Dossiers retained at the Notified Body’s archive are complete and up-to-date.

一般来说，设计更改在MDD (93/42/EEC), 附肵II.4.4有说明，应向公告机构报告确保更改合适（按MED_F_09.04更改通知书格式）。

Furthermore at least one sample of the device should be provided.

此外，至少应提供一个设备样品

For all data SI units of measurement shall be used.

对于所有SI单位的测量数据应得到使用。

Important hint: Design Dossiers that accurately conform to the below guidance can be reviewed more efficiently!

重要提示：设计档案材料准确地符合以下指导可以更有效地进行审查

In this regard it is recommended to compile a Design Dossier or Technical File as follows

在这方面，建议编制设计档案材料或技术文件如下

(也可看NB-MED/2.5.1 和GHTF 文档SG1 (PD)/N011R20: STED):

PART A: Technical File A部分技术文件

1. Table of Content目录