无源医疗器械技术文档和设计档案材料指南.doc

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 IIaand 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 AuthorizedRepresentative 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 Bodys 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, andthe 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 tosupporting 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 B B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。 A部分可用于预先审查，以便即时通知制造商显尔易见的问题或某些具体方面没有包括在设计开发资料中的问题PART B: Annexes B部分 附件1. Essential Requirements Checklist基本要求检查表Example:例:E.R.基本要求applicability all applied是否适用standards (withdate of issue)标准(带有效发布时间)compliancedemonstrated by(referenced documents)证明材料(参考文档)location section所在章节7.1(text)内容Yes是/否ENISO10993-1:2003-5:1999等EN62336=IEC62336laboratory test reports:- cytotoxicity (report number and date)实验室测试报告-细胞毒性(报告编号和日期)Section a) b) c)6.1节See also Attachment I: European Norms and Standards and other Documents supporting Technical Files and Design Dossiers.另见附件I: 欧洲的规范和标准及配套技术文件和其他设计档案材料2. Risk Analysis风险分析The document (Risk Management File) which describes the result of the risk management (including risk analysis, evaluation, mitigation and overall residual risk evaluation and production/post production information see ISO 14971 fig. B1 for an overview) process should contain at least the following information:风险管理文档描述了风险管理的结果(包括风险分析,风险评估,风险降低和剩余风险评价以及按照ISO 14971 fig. B1进行的生产/生产后信息评价),风险分析程序到少包括下面和信息; General information简要信息o Summary概要o Purpose of the document including project phase(s) / life cycle phase(s) for whichthe risk analysis was performed and reviewed Scope (e.g. design/product, manufacturing process, user/operation); product identification and description; intended use, shelf life.文件的目的包括项目阶段（第）/风险分析进行的生命周期阶段（s）和审查范围(例:设计生产制造程序，使用者操作)；产品标识和说明，用途，有效期。o Reference to: Risk Management SOP and Plan, Risk Management Policy, standards (EN ISO 14971, ISO 22442 part 1 -3 and MEDDEV 2.5-8 strongly recommended), specification documents, design documents, procedures, protocols, reports, manufacturing and production process information参考：风险管理标准操作程序和计划，风险管理政策，标准（EN ISO 14971, ISO 22442 第1 -3 和 MEDDEV 2.5-8强制执行），规范文件，设计文档，规程，协议，报告，制造和生产过程的信息o Definition of terms, abbreviations and acronyms术语定义，缩略语o Participants of the risk analysis team (persons and organisations), their qualification,responsibility and authority.风险分析团队（个人和组织），他们的证书，职责和权力。o Note: the Risk Analysis shall include a medical knowledgeable and experiencedexpert in the corresponding field of application.注：风险分析应有一个具有医疗知识和相关领域应用经验的专家o Note: The Risk Management Plan according to ISO 14971 -especially in relation torisk acceptance criteria- has to be defined by the top management under consideration of the estimated production volume to be sold per year and under consideration of regulatory requirements.注：风险管理计划根据ISO 14971尤其是有关风险接受准则已被高层管理人员定义（考虑预计每年的产量和销售量以及监管规定）o Identification of medical device characteristics that could impact on safety, e.g. according to ISO 14971.识别可能影响安全的医疗设备的特征，例：参照ISO 14971o If applicable consideration of data obtained from literature review, usability testing,market surveillance of similar devices, post market surveillance or post marketclinical follow-up (also related to e.g. change notifications, predicate or otherwisecomparable devices): complaint history, incidents per number of devices sold,analysis of underlying causes and final outcome, corrective and preventive actionincluding proof of effectiveness如果适用性审议的数据来自文献回顾，可用性测试，市场类似产品对比，产品售后信息和售后临床随访（其他相关的如：更改通知，其他方式类似装置）投诉历史，事故占销售设备的数量，分析事故原因及最终结果，纠正和预防措施，包括有效的证明。o Revision history修订历史 Methodology评估方法o Hazards / hazardous situations in normal condition: Hazard Analysis; patient/user related (top-down approach), e.g. Fault Tree Analysis, table format在正常状态下的危害/危害性情况;危害分析;病人/相关使用者(自上而下方法),例如:失效的树形分析,表格格式 Clinical experience and clinical risks临床经验和临床风险 Method for identification of applicable hazards; sources of information used识别可适用性危害的方法;所用信息的来源 Method for determination of the potential causes of hazards; sources of information used判定危害的潜在原因的方法;所用信息的来源 System used for categorization of severity levels (e.g. examples); descriptionof consequences to patients, users and other persons严重程度的分类系统(例如:举例);对病人,用户和其它人产生的后果描述 System used for categorization of occurrence of each hazard cause (probabilityestimate, frequency expressed as e.g. events per device and time)每种危害原因产生的分类系统(可能性估计,频率表述为”根据器械和次数的事件”) Method for combination of severity and occurrence to risk level (e.g. diagram,graph, formula)风险水平的严重和发生的组合方法(例如:图表,图形,公式) Criteria for risk acceptance (e.g. acceptable, ALARP, unacceptable) underconsideration of the risk management plan and accumulated risks考虑到风险管理计划和累计风险情况下的风险可接受性标准(例如:可接受, 可操作又合理的最低情况,不可接受) Note: If residual risks remain in ALARP region a rational should be ready tosubstantiate that no further mitigation was possible according to risk controloption analysis.注意:如果剩余风险是在”可操作又合理的最低情况”的范围内,应该根据风险控制选择分析合理地证实没有其它的缓解措施.o Hazards / hazardous situations in fault condition: e.g. FMEA; device related(bottom-up approach)在失效状况下的危害/危害性情况:例如: 潜在失效模式及后果分析;相关器械(自下而上方法) Method for identification of applicable failure modes; sources of informationUsed适用的失效模式识别方法;所用信息来源 Method for determination of the potential causes of failure modes; sources ofinformation used失效模式的潜在原因的判定方法;所用信息来源 System used for categorization of severity levels; description of consequencesto patients, users and other persons严重程度分类系统;对病人,用户和其它人所产生的后果描述 System used for categorization of occurrence of each failure mode (probabilityestimate, frequency expressed as e.g. events per device and time)每种失效模式发生的分类系统(可能性估计,频率表述为”根据器械和次数的事件”) System used for categorization of detectability of each failure mode (criteriafor detectability, frequency of in-process testing: 100%, sampling, or no testingi.e. validated process)每种失效模式的可检测性分类系统(可检测性标准,进程内测试频率:100%,抽样,或者无测试,也就是经验证的过程) Method for combination of severity, occurrence and detectability to risk levelunder consideration of the risk definition (see ISO 14971 2.16) (e.g. diagram,graph, formula)在考虑风险定义(参见ISO 14971 2.16)(例如:图表,图形,公式)情况下, 风险程度的严重,发生和可检测的组合方法 Criteria for risk acceptability (e.g. acceptable, ALARP, unacceptable) underconsideration of the risk management plan and under consideration of accumulatedrisks在考虑风险管理计划和累计风险情况下,风险可接受性的标准(例如:可接受, 可操作又合理的最低情况,不可接受) Note: If residual risks remain in ALARP region a rational should be ready tosubstantiate that no further mitigation was possible according to risk controloption analysis.注意:如果剩余风险是在”可操作又合理的最低情况”的范围内,应该根据风险控制选择分析合理地证实没有其它的缓解措施. Result (signed and dated documents): Risk Management Report结果(文件上有签字和日期):风险管理报告o Hazards / hazardous situations in normal condition正常状态下的危害/危害性状况: list of applicable hazards列出适用危害;for each hazard (table format in hierarchical structure, if applicable)对于每一种危害(层级结构的表格形式,如果适用的话) List of potential worst case effects (description of consequences to patients,users and other persons列出潜在的最坏情况的影响(对病人,使用者和其他人所产生的后果描述) List of potential causes of hazards as appropriate适当列出危害的可能原因 Estimation of risk before mitigation (severity, occurrence, risk) including decisionon acceptability缓解措施前的风险评估(严重,发生,危险),包括可接受性的判定 Definition of risk reduction measures including reference tomethods (e.g. design, testing, manufacturing) and results of verification (implementationand effectiveness)风险降低措施的定义,包括方法(例如:设计,测试,制造),确认结果(实施和有效性) Estimation of risk after mitigation (severity, occurrence, risk) including decisionon acceptability under consideration of the risk management plan and underconsideration of accumulated risks在考虑风险管理计划和累计风险情况下, 缓解措施后的风险评估(严重,发生,危险), 包括可接受性的判定 Risk / benefit weighting under consideration of the state of the art在考虑工艺状态情况下的风险/获益权衡o Hazards / hazardous situations in fault condition: list of applicable failuremodes; for each failure mode (table format in hierarchical structure, if applicable):在失效情况下的危害/危害性情况:列出适用的实失效模式;对于每种失效模式(层级结构的表格形式,如果适用的话): List of potential failure modes列出可能的失效模式 List of potential worst case effects (description of consequences to patients,users and other) 列出潜在的最坏情况的影响对病人,使用者和其他人所产生的后果描述) List of potential causes of failures (as appropriate) 适当列出危害的可能原因 Estimation of risk before mitigation (severity, occurrence, detectability, risk) including decision on acceptability缓解措施前的风险评估(严重,发生,可接受性,危险),包括可接受性的判定 Definition of risk reduction measures including reference to methods (e.g. design,testing, manufacturing) and results of verification (implementation and effectiveness)风险降低措施的定义,包括方法(例如:设计,测试,制造)和验证结果(实施和有效性) Estimation of risk after mitigation (severity, occurrence, detectability, risk) includingdecision on acceptability 缓解措施之后的风险估计(严重,发生,可检测,危险),包括有关于可接受性的决定. Risk / benefit weighting under consideration of the state of the art在考虑工艺水平情况下的风险/获益权衡o New hazards: Assessment of risks associated with new hazards in normal andfault condition generated by risk mitigation measures. Corresponding risk reduction,if applicable新危害:评估与在正常和失效状态下由风险缓解措施所产生的新危害有关联的危害. 相应的风险降低,如果适用的话. Final judgment, statement of对以下内容的最终判断,陈述:o Completeness of risk evaluation风险分析的完整性o Effectiveness of mitigation measures including a link to the verification documents缓解措施的有效性,包括连接到验证文件o Overall acceptability of residual risk剩余风险的整体可接受性o Signed and dated by the team leader or responsible person团队领导或负责人签字并署上日期3. Dra