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 Bodywishes 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2. Introduction介绍3. Design Dossier/Technical File Summary Information设计档案材料/技术文件摘要信息PART B: Annexes B部分附件1. Essential Requirements Checklist基本要求检查表2. Risk Analysis风险分析3. Drawings, Design -, Product - Specifications图纸，设计- 产品- 规格4. Chemical, Physical and Biological Tests化学，物理和生物测试4.1 In Vitro Testing - Preclinical Studies体外试验- 临床前研究4.2 In Vivo Testing - Preclinical Studies体内试验- 临床前研究4.3 Biocompatibility Tests生物相容性测试4.4 Bio-stability Tests生物稳定性试验4.5 Microbiological Safety, Animal Origin Tissue微生物安全，动物保护组织4.6 Drug / medical device combination药物/医疗设备组合4.7 Blood Derivates, Human Tissue / medical device combination血液衍生物，人体组织/医疗设备组合4.8 Coated Medical Devices涂层医疗器械5. Clinical Data临床资料6. Labels and Instructions for Use标签和使用说明7. Manufacturing制造8. Package Qualification and Shelf life包装和保质期9. Sterilization灭菌10. Conclusion结论11. Declaration of Conformity (Draft)符合性声明（草稿）PART A: Technical File A部分技术文件1. Table of Content 目录Content of both Parts A and B目录包括A部分和B部分2. Introduction 介绍• Revision history of Design Dossier: change notifications, revision numbers and approvals of all documents including all amendments.设计文档案修订历史：更改通知，版本号和批准的所有文件，包括所有的修订• Regulatory Information法规信息o Name, postal address, Notified Body, certifications (valid copies attached!) of:以下机构的名称，通讯地址，公告机构，证书（有效的复的复印件）▪ the manufacturer (incl. contact person)制造商（包括联系人）▪ OEM, critical suppliers, subcontractors (e.g. contract sterilizer) OEM，关键供应商，外协商（例如：合同灭菌商）▪ European Representative (if applicable)欧盟代表（如果适用）o Product and accessory classification, rule according to MDD, Annex IX and according to ISO 10993-1 Table 1 and 2产品及配件分类：按照MDD规定的附录9和ISO10993-1表1和表2o Conformity Assessment Route合格评定路径Annex II.3+II.4o UMDNS-/GMDS-code UMDNS-/GMDS 编号o Product History: approvals (e.g. FDA 510(k) or PMA clearance), market release, status of any pending request for market clearance; items sold 上市销售历史，证书，时间，数量• Brief description of the product产品简要描述o Intended use, model names, configurations, variants产品预期用途，型号规格名称，配置和规格表o Accessories for the product, integral parts of package产品的附件,同一包装的部件o Applied standards (list or table including the full title, identifying numbers, date, and the organization that created the standard)适用标准（全名的列标，包括编号，日期和该标准的编制机构）特别协调标准Note: Please make sure to use current standards only or provide a gap analysisand rationale注：请务必使用唯一最新标准或提供差距分析和理由o Rationale if applicable standards or parts thereof have not been considered 如为何没有采用当前标准或部分标准的理由3. Design Dossier / Technical File Summary Information (reference to supporting documents filed in Part B)设计档案材料/技术文件摘要信息（参照B部分支持文档）• Comprehensive description of the system and each functional component of the device and the related accessories including utilized material or ingredient (animal/human origin, drug device combination?), packaging, method of sterilization, shelf life, combination with active medical devices. The description should be supported by diagrams, photographs or drawings, as appropriate.综合描述：整个系统的（包括包装），产品的每个功能部件和相关的附件包括关键材料或组成部分（动物/人类,药物组合装置）,包装,灭菌方法,有效期,配合使用的有源医疗器械,描述应有适用的简图,照片或工程图.• Basic scientific concepts that form the fundamentals for the device including medical,biological, chemical, and physical background information产品依据的基本的科学概念,包括材料,生物,化学和物理背景资料.• In case of a Change Notification: description of all changes in comparison with the previous design or manufacturing process (e.g. tabular format)更改通知:所有的变化描述与先前的设计或制造过程中的比较(例如:列表的格式)• Summary of the essential data and results as detailed in Part BB部分中关键数据和结果摘要• Information as provided in the Instructions / Directions for Use (detailed in section B): Intended Use, Indication, Contraindications, Warnings, Adverse events, Operation and use of accessories使用说明提供的信息:使用指导(详细见B部分),用途,标志,禁忌,警告,不良反应,操作和使用的配件• Planned changes计划中的改变（规格型号）• Summary description of manufacturing process简要介绍制造过程• Any other important safety/performance related information.任何其他重要的安全特性:性能相关的信息This structure enables efficient project planning and management. Part A can be used for a pre-review in order to instantly notify the manufacturer of open issues or in case particular aspects are not covered in the Design Dossier.这种结构应该能够有效的项目规划和管理。