Contents of Technical File
Contents | Notes | |
Part A | ||
1 | Name, Postal Address of Manufacturer /EU Representive | |
2 | A listing of all manufacturing sites covered by the quality system | |
3 | Product description | |
3.1 | Product name, classification of the device and accessories | |
3.2 | List of accessories (if applicable) | |
3.3 | Specification, model and article numbers | |
3.4 | Chosen conformity assessment path | |
3.5 | Intended use | |
3.6 | Integral parts of the sales unit | |
3.7 | A brief product history (including existing regulatory approvals) | |
4 | List of harmonized standards | Satisfy the Annex I |
5 | Essential Requirements checklist | the solutions adopted to satisfy the Essential Requirements (template, English version) |
6 | Overall manufacturing and inspection plan of the product | |
7 | Risk analysis | EN ISO 14971:2007 (template, English version) |
8 | Clinical report | Detailed see in Part B |
9 | Labelling, inl. Product labels and package labels | (English version) |
10 | Instruction for use, patient information, advertising material | (English version) |
11 | Declaration of conformity | (template, English version) |
Part B | ||
12 | Information concerning the quality system specific to the product | |
13 | Detailed descriptions of the product | |
13.1 | Design drawings and product specifications | |
13.2 | Packaging and specification | (English version) |
13.3 | Description of the manufacturing processes | Drawings, qualification, Labeling control, Traceability,Product and environmental bioburden particles, Pyrogene testing, Preventive monitoring of processes (i.e. SPC), Viral- Prion Desactivation steps etc. |
13.4 | Raw materials and suppliers | |
14 | Test, verification and evaluation report | |
14.1 | Sterile method and validation | IQ/OQ/PQ |
14.2 | Packaging verification (if applicable) | Incl. package expired date |
14.3 | Chemical, physical and biology test, verification and evaluation report | |
15 | Clinical datas | The critical report must be in Part A of the Technical File. The publications quoted in the report must be available in Part B of the Technical File as original documents, reprints or copies. |
15.1 | Preclinical Evaluation, Expert Opinions | |
15.2 | Clinical plan | |
15.3 | Clinical datas | |
15.4 | Clinical Summary, Expert Opinions | |
15.5 | Clinical report | |
15.6 | Relevant Literature | |
技 術(shù) 文 檔 的 內(nèi) 容
內(nèi) 容 | 備 注 | |
Part A | ||
1 | 制造商和 歐洲代表的名字、地址 | |
2 | 質(zhì)量體系所涉及的全部制造場(chǎng)所清單 | |
3 | 產(chǎn)品描述 | |
3.1 | 產(chǎn)品名字、器械及附件的分類(lèi) | |
3.2 | 產(chǎn)品附件清單（適用時(shí)） | |
3.3 | 規(guī)格、型號(hào)及貨號(hào) | |
3.4 | 符合性評(píng)價(jià)路徑 | |
3.5 | 預(yù)期用途描述 | |
3.6 | 主要的銷(xiāo)售單元（適用時(shí)） | |
3.7 | 簡(jiǎn)要的產(chǎn)品歷史（包括現(xiàn)有的管理審批） | |
4 | 適用的標(biāo)準(zhǔn)清單 | 符合醫(yī)療器械指令附錄I |
5 | 基本要求檢查表 | 符合醫(yī)療器械指令附錄I的方案 (有固定模板，需提交英文文件) |
6 | 產(chǎn)品的總體生產(chǎn)或質(zhì)量控制方案 | |
7 | 風(fēng)險(xiǎn)分析 | EN ISO 14971:2007 有固定模板，需提交英文文件 |
8 | 臨床報(bào)告 | 詳細(xì)的臨床數(shù)據(jù)見(jiàn)Part B |
9 | 標(biāo)簽，包括產(chǎn)品標(biāo)簽、包裝標(biāo)簽 | (需提交英文文件) |
10 | 使用說(shuō)明、患者信息、廣告材料 | (需提交英文文件) |
11 | 符合性聲明 | (有固定模板，需提交英文文件) |
Part B | ||
12 | 與產(chǎn)品有關(guān)的質(zhì)量體系的信息 | |
13 | 詳細(xì)的產(chǎn)品描述 | |
13.1 | 設(shè)計(jì)圖及產(chǎn)品技術(shù)規(guī)范 | |
13.2 | 包裝條件及規(guī)格 | (需提交英文文件) |
13.3 | 生產(chǎn)過(guò)程描述 | 包括流程圖、資格確認(rèn)、標(biāo)簽控制、追溯性、產(chǎn)品及生產(chǎn)環(huán)境控制、過(guò)程的預(yù)防監(jiān)控、消毒或防護(hù)過(guò)程等 |
13.4 | 原材料和供方 | |
14 | 試驗(yàn)、驗(yàn)證及評(píng)估報(bào)告 | |
14.1 | 滅菌方法和驗(yàn)證的概述，滅菌證書(shū)（適用時(shí)） | IQ/OQ/PQ |
14.2 | 包裝驗(yàn)證（適用時(shí)） | 包括包裝有效期驗(yàn)證 |
14.3 | 化學(xué)、物理和生物學(xué)試驗(yàn)、驗(yàn)證或評(píng)估報(bào)告 | |
15 | 臨床數(shù)據(jù) | 臨床評(píng)價(jià)報(bào)告必須包含在技術(shù)文檔的第一部分中，報(bào)告中引用的出版物必須以原始文件、重印本或復(fù)印件的形成在即數(shù)文檔的第二部分提供 |
15.1 | 臨床前評(píng)估，專(zhuān)家意見(jiàn) | |
15.2 | 臨床方案 | |
15.3 | 臨床數(shù)據(jù) | |
15.4 | 臨床總結(jié)，專(zhuān)家意見(jiàn) | |
15.5 | 臨床報(bào)告 | |
15.6 | 相關(guān)文獻(xiàn) | |
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