為讓技術文件梳理更清晰，這里整合了技術文檔結構清單，方便大家準備 CE 技術文件。
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1 Device Description and Specifications Including Variants and Accessories
1 設備描述和規(guī)格，包括變體和附件
1.1 Device Description
1.1 設備描述
1.1.1 General description including product or trade names, principles of operation, mode of action etc
1.1.1 總體描述，包括產品或商品名稱、操作原理、作用模式等
1.1.2 Accessories included
1.1.2 包含的附件
1.1.3 Accessories not included but necessary for us
1.1.3 未包含但為我們所需的附件
1.2 Intended Purpose and Intended Users
1.2 預期用途和預期用戶
1.2.1 Intended purpose including any clinical claims
1.2.1 預期用途，包括任何臨床聲明
1.2.2 Intended users
1.2.2 預期用戶
1.3 Basic UDI-DI & EMDN code
1.3 基本UDI-DI和EMDN代碼
1.3.1 Basic UDI-DI and any other relevant UDI related information
1.3.1 基本UDI-DI及任何其他相關的UDI信息
1.3.2 EMDN code (previously referred to as CND code)
1.3.2 EMDN代碼（先前稱為CND代碼）
1.4 Devices covered by technical documentation
1.4 技術文檔所涵蓋的設備
1.4.1 List of type, sizes, configurations, variants etc including catalogue numbers covered by the submitted technical documentation
1.4.1 類型、尺寸、配置、變體等的列表，包括提交的技術文檔所涵蓋的編號
1.5 Classification
1.5 分類
1.5.1 Classification of the device including all the applicable rules and relevant rationales
1.5.1 設備的分類，包括所有適用規(guī)則和相關理由
1.6 Materials
1.6 材料
1.6.1 Description and identification of key materials incorporated into the device
1.6.1 設備中關鍵材料的描述和識別
1.6.2 Identification of any tissues or cells of human or animal origin that may have been utilised in the manufacture of the device
1.6.2 識別制造設備中可能使用的任何人類或動物來源的組織或細胞
1.6.3 Bill of Materials
1.6.3 材料清單
1.7 Market History
1.7 上市歷史
1.7.1 Overview of relevant market history of the device (e.g. Date of first making available, Units sold, Previous models, Current and previous regulatory approvals)
1.7.1 設備相關市場歷史概述（例如：首次上市日期、銷售數量、先前型號、當前和先前的監(jiān)管批準）
1.7.2 Overview of similar devices available in EU or other markets
1.7.2 歐盟或其他市場可用類似設備的概述
02
2 Information Supplied by the Manufacturer
2 制造商提供的信息
2.1 User Information
2.1 用戶信息
2.1.1 Device or Product labelling
2.1.1 設備或產品標簽
2.1.2 Sterile packaging labelling
2.1.2 無菌包裝標簽
2.1.3 Single unit packaging labelling
2.1.3 單包裝標簽
2.1.4 Sales packaging labelling
2.1.4 銷售包裝標簽
2.1.5 Transport packaging labelling
2.1.5 運輸包裝標簽
2.1.6 Instructions for use / Device Operating Manual(s)
2.1.6 使用說明/設備操作手冊
2.1.7 Patient handbook
2.1.7 患者手冊
2.1.8 Physicians handbook
2.1.8 醫(yī)師手冊
2.1.9 Implant card information
2.1.9 植入卡信息
2.1.10 Electronic IFU (e-IFU) information (if applicable, and as per (EU) 207/2012)
2.1.10 電子IFU（e-IFU）信息（如適用，并根據(EU) 207/2012）
2.1.11 Copies of promotional materials (that mention that the device fulfils the requirements of CE marking) including any that make specific claims related to the device
2.1.11 宣傳資料副本（提及設備符合CE標記要求），包括任何與設備相關的具體聲明
2.1.12 URL of the website where the IFU (and any other labelling information as relevant) will be made available as per GSPR 23.1
2.1.12 根據GSPR 23.1將提供IFU（及任何其他相關標簽信息）的網站URL
03
3 Design and Manufacturing Information
3 設計和制造信息
3.1 Design stages
3.1 設計階段
3.1.1 Summary of design stages applied to the device
3.1.1 應用于設備的設計階段摘要
3.2 Product & Design specifications
3.2 產品和設計規(guī)格
3.2.1 Key product/design specifications of the device
3.2.1 設備的關鍵產品/設計規(guī)格
3.2.2 User requirements
3.2.2 用戶需求
3.3 Manufacturing information
3.3 制造信息
3.3.1 Overview of the Manufacturing process which also identifies any critical processes involved, including, if relevant, whether sterilisation is conducted on-site or sub-contracted
3.3.1 制造過程概述，同時識別涉及的任何關鍵過程，包括（如相關）滅菌是否在現場進行或分包
3.3.2 Critical process verification protocols/plans
3.3.2 關鍵過程驗證計劃
3.3.3 Critical process verification reports
3.3.3 關鍵過程驗證報告
3.3.4 Critical process validation protocols/plans
3.3.4 關鍵過程確認計劃
3.3.5 Critical process validation reports
3.3.5 關鍵過程確認報告
3.3.6 Incoming inspections and acceptance criteria & results from a sample batch
3.3.6 來料檢驗和接受標準及樣本批次的結果
3.3.7 In-process inspections and acceptance criteria & results from a sample batch
3.3.7 過程中檢驗和接受標準及樣本批次的結果
3.3.8 Final inspections and acceptance criteria & results from a sample batch
3.3.8 最終檢驗和接受標準及樣本批次的結果
3.3.9 Installation and Commissioning tests
3.3.9 安裝和調試測試
3.4 Sites involved in design and manufacturing activities
3.4 涉及設計和制造活動的場地
3.4.1 Legal Manufacturer (as per EUDAMED registration)
3.4.1 法律制造商（根據EUDAMED注冊）
3.4.2 European Representatives
3.4.2 歐洲代表
3.4.3 Site with Design responsibility
3.4.3 負責設計的場地
3.4.4 Sterilisation subcontractors
3.4.4 滅菌分包商
3.4.5 Other critical subcontractors and crucial suppliers relevant to the device(s) including any copies of certification held by such entities
3.4.5 與設備相關的其他關鍵分包商和重要供應商，包括這些實體持有的任何認證副本
04
4 General Safety and Performance Requirements (GSPRs)
4 通用安全與性能要求（GSPRs）
4.1 Demonstration of conformity with GSPRs
4.1 符合GSPRs的證明
4.1.1 GSPR checklist (or in any other format) that meets the requirements of MDR Annex II section 4
4.1.1 符合MDR附錄II第4節(jié)要求的GSPR檢查表（或任何其他格式）
4.1.2 Standards applied including whether applied in part or full along with the version/date of the standards applied
4.1.2 應用的標準，包括部分或全部應用以及所應用標準的版本/日期
4.1.3 Common Specifications applied
4.1.3 應用的通用規(guī)范
4.1.4 Other applicable Regulations & Directives (PPE, Machinery, e-IFU regulation etc)
4.1.4 其他適用的法規(guī)和指令（PPE、機械、e-IFU法規(guī)等）
05
5 Benefit-Risk Analysis and Risk Management
5 受益-風險分析和風險管理
5.1 Benefit-risk analysis
5.1 受益-風險分析
5.1.1 Benefit-risk analysis (as per GSPR #1 and #8)
5.1.1 受益-風險分析（根據GSPR #1和#8）
5.2 Risk Management
5.2 風險管理
5.2.1 Risk management procedure
5.2.1 風險管理程序
5.2.2 Risk management plan
5.2.2 風險管理計劃
5.2.3 Risk scoring system
5.2.3 風險評分系統
5.2.4 Design risk assessment
5.2.4 設計風險評估
5.2.5 Production/process risk assessment
5.2.5 生產/過程風險評估
5.2.6 Clinical/Application/Product risk assessment
5.2.6 臨床/應用/產品風險評估
5.2.7 Risk management report
5.2.7 風險管理報告
06
6 Product Verification and Validation
6 產品驗證和確認
6.1 Biocompatibility
6.1 生物相容性
6.2 Electrical safety and electromagnetic compatibility (EMC)
6.2 電氣安全和電磁兼容性（EMC）
6.3 Software Verification and Validation
6.3 軟件驗證和確認
6.4 Stability, including shelf life (to include both device and packaging performance)
6.4 穩(wěn)定性，包括保質期（包括設備和包裝性能）
6.5 Performance and Safety - Design Verification and Validations
6.5 性能和安全 - 設計驗證和確認
6.6 Clinical Evaluation
6.6 臨床評價
6.7 Post Market Surveillance & Post Market Clinical Follow-up
6.7 上市后監(jiān)督和上市后臨床隨訪
6.8 Devices incorporating medicinal substances (Medicinal dossier that complies to MEDDEV 2.1/3 in CTD bookmarked format, as a standalone document)
6.8 包含藥用物質的設備（符合MEDDEV 2.1/3的藥用檔案，以CTD書簽格式作為獨立文檔）
6.9 Devices utilising tissue and cells of human or animal origin or their derivatives or other non-viable biological substances (as per GSPR 13.3)
6.9 使用人類或動物來源的組織或細胞或其衍生物或其他非活性生物物質的設備（根據GSPR 13.3）
6.10 Devices composed of substances that are absorbed by or locally dispersed in the human body (Rule 21 devices)
6.10 由被人體吸收或局部分散的物質組成的設備（規(guī)則21設備）
6.11 Devices containing CMR or endocrine-disrupting substances referred to in GSPR 10.4.1 of Annex I of MDR
6.11 含有MDR附錄I GSPR 10.4.1中提及的CMR或內分泌干擾物質的設備
6.12 Packaging and Transit (Transport) testing
6.12 包裝和運輸測試
6.13 Sterilisation Validation
6.13 滅菌確認
6.14 Reusable surgical instruments
6.14 可重復使用的外科器械
6.15 Devices with a measuring or diagnostic function
6.15 具有測量或診斷功能的設備
6.16 Devices intended to be connected to other devices to operate as intended
6.16 旨在連接到其他設備以按預期操作的設備
6.17 Magnetic resonance imaging safety of implants
6.17 植入物的磁共振成像安全性
6.18 Declaration of Conformity
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