(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)
(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）。
CE中英文
COUNCIL DIRECTIVE 93/42/EECof 14 June 19931993年6月14日理事会第93/42/EEC号指令concerning medical devices关于医疗器械THE COUNCIL OF THE EUROPEAN COMMUNITIES,欧洲共同体理事会Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof, 依据欧洲经济体所制订的罗马条约, 特别是第100a条规定Having regard to the proposal from the Commission依据执委会的建议案In cooperation with the European Parliament配合欧洲议会Having regard to the opinion of the Economic and Social Committee,依据经济暨社会委员会的意见Whereas measures should be adopted in the context of the internal market; whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;鉴于内部市场的完成应采取一些措施; 鉴于内部市场是一无内部疆界的区域, 区域内的货物, 人员, 服务及资金应可自由流通Whereas the content and scope of the laws, regulations and administrative provisions in force in the Member States with regard to the safety, health protection and performance characteristics of medical devices are different; whereas the certification and inspection procedures for such devices differ from one Member State to another; whereas such disparities constitute barriers to trade within the Community;鉴于各会员国间现存有关医疗器械的安全, 对健康的保护及使用特性方面的法律, 法规及行政命令的内容与范围不尽相同; 鉴于各会员国对此器械的验证及检验程序也不相同; 鉴于前述的分歧将阻碍共同体内的贸易活动;Whereas the national provisions for the safety and health protection of patients, users and, where appropriate, other persons, with regard to the use of medical devices should be harmonized in order to guarantee the free movement of such devices within the internal markert;鉴于医疗器械的使用对病患, 使用者, 甚至其他人有关安全及健康保护的相关国家规定应加以调和, 以保证此类器械在内部市场能自由流通;Whereas the harmonized provisions must be distinguished from the measures adopted by the Member States to manage the funding of public health and sickness insurance schemes relating directly or indirectly to such devices; whereas, therefore, the provisions do not affect the ability of the Member States to implement the abovementioned measures provided Community law is complied with;鉴于调和的规定必然与各会员国采取的部分措施有所不同, 这些措施是为筹措公共健康与疾病保险计划的基金, 且直接或间接与医疗器械有关; 鉴于共同体若与上述措施相符, 则这些规定并不影响会员国落实上述措施的能力;Whereas medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer; whereas, therefore, the maintenance or improvement of the level of protection attained in the Member States is one of the essential objectives of this Directive;鉴于医疗器械应提供病患, 使用者及第三者高度的保护, 且应该达到厂商所要求的性能水准; 鉴于维持或改进各会员国对病患等保护的程度乃本指令目的的一;Whereas certain medical devices are intended to administer medicinal products within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products; whereas, in such cases, the placing on the market of the medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by Directive 65/65/EEC; whereas if, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral unit which is intended exclusively for use in the given combination and which is not reusable, that single-unit product shall be governed by Directive 65/65/EEC; whereas a distinction must be drawn between the abovementioned devices and medical devices incorporating, inter alia, substances which, if used separately, may be considered to be a medicinal substance within the meaning of Directive 65/65/EEC; whereas in such cases, if the substances incorporated in the medical devices are liable to act upon the body with action ancillary to that of the device, the placing of the devices on the market is governed by this Directive; whereas, in this context, the safety, quality and usefulness of the substances must be verified by analogy with the appropriate methods specified in Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products;鉴于部分医疗器械是符合1965年1月26日理事会第65/65/EEC号指令, 与专卖医药产品有关的法律, 法规或管理行为所订的实施规定, 鉴于医疗器械的上市基本上由本指令规范, 但医疗产品的上市则受65/65/EEC号指令规范; 鉴于若有某种器械须与其他医疗产品组成一完整的产品而上市销售, 使用, 且无法二次使用时, 则该组合产品应受65/65/EEC 号指令规范; 鉴于前述的医疗器械和包含医疗物质且该物质单独使用时符合65/65/EEC号指令规定的医疗器械应加以区别; 鉴于前述包含于医疗器械的医疗物质若对人体产生作用以辅助医疗器械的作用时, 则该医疗器械的上市应由本指令规范; 鉴于1975年5月20日75/318/EEC号理事会指令[制定各会员国在测试专利医疗产品方面有关分析药物毒性和临床的标准及调查书的法律调和], 医疗物质的安全, 品质及效用在前述情况下则须依该指令明定的适当方法加以证实;Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any reference to 'minimizing' or 'reducing' risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety;鉴于本指令附录所订的基本要求及其他要求, 包括[最低]或[降低]危险部分的应用, 应考虑设计当时的科技及实施情形, 并在符合健康和安全高度保护的原则下考虑技术及经济的因素;Whereas, in accordance with the principles set out in the Council resolution of 7 May 1985 concerning a new approach to technical harmonization and standardization, rules regarding the design and manufacture of medical devices must be confined to the provisions required to meet the essential requirements; whereas, because they are essential, such requirements should replace the corresponding national provisions;鉴于为符合1985年5月7日理事会决议中有关技术调和与标准化新方针所订定的原则, 有关医疗器械的设计及执照应遵守相关条款以符合基本要求; 鉴于这些要求属基本要求, 所以应取代对应的国家规定;whereas the essential requirements should be applied with discretion to take account of the technological level existing at the time of design and of technical and economic considerations compatible with a high level of protection of health and safety;鉴于基本要求的落实应谨慎考虑设计当时的科技水准, 并在符合健康和安全高度保护的原则下考虑技术及经济的因素;Whereas Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices is the first case of application of the new approach to the field of medical devices; whereas in the interest of uniform Community rules applicable to all medical devices, this Directive is based largely on the provisions of Directive 90/385/EEC; whereas for the same reasons Directive 90/385/EEC must be amended to insert the general provisions laid down in this Directive;鉴于1990年6月20日通过的90/385/EEC号[各会员国有关主动植入式医疗器械法律调和] 的理事会指令是第一个应用在医疗器械方面的新方法指令; 鉴于为使共同体规定适用于所有的医疗器械, 本指令基本上是以90/385/EEC号指令的条款为依据; 鉴于90/385/EEC号指令,因此也必须增加本指令所列的一般条款的部分;Whereas the electromagnetic compatibility aspects form an integral part of the safety of medical devices; whereas this Directive should contain specific rules on this subject with regard to Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility;鉴于医疗器械的电磁相容性是整个产品安全的一部分; 鉴于本指令因此须包括1989年5月3日89/336/EEC号[各会员国有关电磁相容性法律调和]的理事会指令中所制订的特定规定;Whereas this Directive should include requirements regarding the design and manufacture of devices emitting ionizing radiation; whereas this Directive does not affect the authorization required by Council Directive 80/836/Euratom of 15 July 1980 amending the Directives laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation, nor application of Council Directive 84/466/Euratom of 3 September 1984 laying down basic measures for the radiation protection of persons undergoing medical examination or treatment; whereas Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work and the specific directives on the same subject should continue to apply;鉴于本指令应包含释放电离辐射医疗器械设计及制造的相关要求; 鉴于本指令不影响1980年7月15日80/836/Euratom 理事会指令所需要的授权, 该指令目的在修订为保护大众及工作人员健康, 防止电离辐射危险而制订基本安全标准的其他指令; 本指令亦不影响1984年9月3日84/466/Euratom号[制订保护人员在医疗检查或治疗中不受辐射影响的基本方法] 理事会指令的适用; 鉴于1989年6月12日89/391/EEC号理事会指令[鼓励改善工作场所中工人的安全与健康]及其他相关主题的指令应持续适用;Whereas, in order to demonstrate conformity with the essential requirements and to enable conformity to be verified, it is desirable to have harmonized European standards to protect against the risks associated with the design, manufacture and packaging of medical devices; whereas such harmonized European standards are drawn up by private-law bodies and should retain their status as non-mandatory texts; whereas, to this end, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) are recognized as the competent bodies for the adoption of harmonized standards in accordance with the general guidelines on cooperation between the Commission and these two bodies signed on 13 November 1984;鉴于为证明符合基本要求并使该符合性得以落实, 有必要建立调和的欧洲标准, 以避免医疗器械在设计, 制造及包装上所可能带来的危险, 鉴于调和的欧洲标准由私人立法机构制订, 而且应维持自愿性质; 鉴于欧洲标准化委员会(CEN) 及欧洲电工标准化委员会(CENELEC) 被认为是制订调和标准有能力的团体(competent bodies),而此标准符合1984年11月13日执委会与上述两团体所签订的合作纲要为基础的一般指导原则;Whereas, for the purpose of this Directive, a harmonized standard is a technical specification (European standard or harmonization document) adopted, on a mandate from the Commission, by either or both of these bodies in accordance with Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations, and pursuant to the abovementioned general guidelines; whereas with regard to possible amendment of the harmonized standards, the Commission should be assisted by the Committee set up pursuant to Directive 83/189/EEC; whereas the measures to be taken must be defined in line with procedure I, as laid down in Council Decision 87/373/EEC; whereas, for specific fields, what already exists in the form of European Pharmacopoeia monographs should be incorporated within the framework of this Directive; whereas, therefore, several European Pharmacopoeia monographs may be considered equal to the abovementioned harmonized standards;鉴于为达本指令目的, 调和标准是前述机构接获理事会命令后, 依理事会1983年3月28日通过的83/189/EEC号指令[有关制订技术标准及法规资讯提供的程序]而采纳的技术规范(欧洲标准或调和文件, 符合前述一般纲要的规定 ; 鉴于调和标准的修正有赖于83/189/EE号指令建立的委员会的协助; 鉴于应采取的措施须依照理事会87/378/EEC号指令程序一的规定; 鉴于特殊领域中现存的欧洲药典专题论文应纳入本指令的架构中; 因此数篇欧洲药典专题论文将视其与前述调和标准有着同等的效力;Whereas, in Decision 90/683/EEC of 13 December 1990 concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization directives, the Council has laid down harmonized conformity assessment procedures; whereas the application of these modules to medical devices enables the responsibility of manufacturers and notified bodies to be determined during conformity assessment procedures on the basis of the type of devices concerned; whereas the details added to these modules are justified by the nature of the verification required for medical devices;鉴于理事会在1990年12月13日通过的90/683/EEC号[有关技术调和指令适用的符合评鉴程序各阶段模式]决定中制定调和的符合评鉴程序; 鉴于这些模式于医疗器械的应用, 可以依相关器械的型式决定制造商及公告机构在符合评鉴程序中应负的责任; 鉴于医疗器械的证明有必要在模式里增加细节的规定;Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group the devices into four product classes; whereas the classification rules are based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the devices; whereas the conformity assessment procedures for Class I devices can be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products; whereas, for Class IIa devices, the intervention of a notified body should be compulsory at the production stage; whereas, for devices falling within Classes IIb and III which constitute a high risk potential, inspection by a notified body is required with regard to the design and manufacture of the devices; whereas Class III is set aside for the most critical devices for which explicit prior authorization with regard to conformity is required for them to be placed on the market;鉴于为达到符合评鉴的目的有必要将医疗器械分为四类; 鉴于分类是以考虑器械的技术设计及制造对易受伤的人体可能带来的危险程度为原则; 鉴于第I类医疗器械对人体可能产生的伤害较轻微, 其符合性评鉴程序大致可由制造商完全负责执行; 鉴于对第II(a)类医疗器械而言, 在生产阶段时公告机构的介入应属强制性质; 鉴于属于第II(b)类及第III类的医疗器械对人体具有较高的潜在危险, 因此在器械的设计及制造阶段必须有公告机构的检验; 鉴于第III类的器械皆为较特别的器械, 其一致性需在上市的前获得明确授权;Whereas in cases where the conformity of the devices can be assessed under the responsibility of the manufacturer the competent authorities must be able, particularly in emergencies, to contact a person responsible for placing the device on the market and established in the Community, whether the manufacturer or another person established in the Community and designated by the manufacturer for the purpose;鉴于器械的一致性如能由制造商负责评鉴, 相关主管机关, 特别是紧急状况时, 应能联络到一位设于共同体内负责将器械在市场上销售的人员, 该人员可以是制造商本人或其他设于共同体内经制造商授权的人员;Whereas medical devices should, as a general rule, bear the CE mark to indicate their conformity with the provisions of this Directive to enable them to move freely within the Community and to be put into service in accordance with their intended purpose;鉴于医疗器械应附加CE标志, 表示其符合本指令的条款, 而得以在共同体市场上自由流通并依其设计的目的使用;Whereas, in the fight against AIDS and in the light of the conclusions of the Council adopted on 16 May 1989 regarding future activities on AIDS prevention and control at Community level, medical devices used for protection against the HIV virus must afford a high level of protection; whereas the design and manufacture of such products should be verified by a notified body;鉴于为抵抗爱滋病, 并顾及理事会于1989年5月16日采纳有关共同体层次未来防止暨控制爱滋病相关活动的结论, 用于防止HIV病毒感染的医疗器械应提供人体高度的保护; 此类产品的设计及制造应由公告机构的证实;Whereas the classification rules generally enable medical devices to be appropriately classified; whereas, in view of the diverse nature of the devices and technological progress in this field, steps must be taken to include amongst the implementing powers conferred on the Commission the decisions to be taken with regard to the proper classification or reclassification of the devices or, where appropriate, the adjustment of the classification rules themselves;whereas since these issues are closely connected with the protection of health, it is appropriate that these decisions should come under procedure IIIa, as provided for in Directive 87/373/EEC;鉴于前述的分类原则大多可以适当地将医疗器械分类; 鉴于医疗器械性质及相关领域技术进步的性质各异, 因此必须采取一些措施以决定授予执委会的执行权力及有关器械的分类或再分类, 或者于适当时调整分类的原则; 鉴于上述的问题与人员健康的保护有着密切的关联, 因此这些决议应依照87/373/EEC号指令程序IIIa规定;Whereas the confirmation of complicance with the essential requirements may mean that clinical investigations have to be carried out under the responsibility of the manufacturer; whereas, for the purpose of carrying out the clinical investigations, appropriate means have to be specified for the protection of public health and public order;鉴于制造商有责任执行临床调查以证明其医疗器械符合安全要求; 因此为保证大众健康及秩序应明订执行临床调查的适当方法;Whereas the protection of health and the associated controls may be made more effective by means of medical device vigilance systems which are integrated at Community level;鉴于健康的保护及相关的管制方法以在共同体层次上建立一个医疗装置警戒系统为最有效;Whereas this Directive covers the medical devices referred to in Council Directive 76/764/EEC of 27 July 1976 on the approximation of the laws of the Member States on clinical mercury-in-glass, maximum reading thermometers; whereas the abovementioned Directive must therefore be repealed; whereas for the same reasons Council Directive 84/539/EEC on 17 September 1984 on the approximation of the laws of the Member States relating to electro-medical equipment used in human or veterinary medicine must be amended,鉴于理事会于1976年7月27日通过76/764/EEC号[有关各会员国水银玻璃最高温度计法律调和] 的指令中所提及的医疗器械亦受本指令规范; 前述指令因此必须撤销;基于同样原因, 理事会1984年9月17日通过的84/539/EEC号指令[有关各会员国人类或动物医疗使用的电动医疗器械法律调和],HAS ADOPTED THIS DlRECTIVE:爰制订本指令:Article 1第 1 条Definitions, scope定义, 范围1. This Directive shall apply to medical devices and their accessories. For the purposes of this Directive,accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices.本指令适用于医疗器械及其附属物. 附属物在本指令的适用范围内亦视其为医疗器械. 两者以下皆称器械.2. For the purposes of this Directive, the following definitions shall apply:为本指令的目地, 下列定义适用于:(a) medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or incombination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:[医疗器械]是指制造商设计供人类于下列情况, 不论是单独或合并使用的仪器, 设备, 器械, 材料或其他物品, 包括适当应用所需的软体, 而此种应用是厂商为人们下列的目地而订定:- diagnosis, prevention, monitoring, treatment or alleviation of disease,诊断, 预防, 追踪, 治疗或减轻疾病,- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,诊断, 追踪, 治疗或修整伤处或残障部位,- investigation, replacement or modification of the anatomy or of a physiological process,解剖或生理过程中的检查, 换置或修正,- control of conception,生育控制,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;这些器械不可借药性, 免疫力或新陈代谢的方法在人体内达到其主要设计的目的, 但可用这些器械辅助其功能者;(b) 'accessory' means an article which whilst not being a device is intended specifically by its manufacturer to beused together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;[附属物]是指本身不可独立使用的器械, 制造商设计附属件的目地是配合其他器械合并使用, 使该器械得以依其设计目地发生功用;(c) 'device used for in vitro diagnosis' means any device which is a reagent, reagent product, kit, instrument,equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of samples derived from the human body with a view to providing information on the physiological state, state of health or disease, or congenital abnormality thereof;[体外诊断用器械] 是指任何自成单位或与其他物件组合的任何试剂, 试剂品, 套装用具, 仪器, 设备或系统形态的器械. 这种器械是制造商设计作为检查人体组织标本用的器械, 以期能够提供有关其生理状况, 健康或生病或任何先天不正常等讯息;(d) 'custom-made device' means any device specifically made in accordance with a duly qualified medicalpractitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient.[订制的器械] 是指依照合格医疗从业人员描述的特色而特别制作的器械, 该器械是为特定病患设计且专供该病患使用.The above mentioned prescription may also be made out by any other person authorized by virtue of his professional qualifications to do so.前述的描述可以由专业资格而获授权的其他人提供.Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or. any other professional user are not considered to be custom-made devices;但订制的器械不包括那些为满足医疗人员或其他专业使用人要求而改装且大量生产的器械 .(e) 'device intended for clinical investigation' means any device intended for use by a duly qualified medicalpractitioner when conducting investigations as referred to in Section 2.1 of Annex X in an adequate human clinical environment.[临床调查用的器械]是指由适当的合格医疗从医人员在适当的人类临床环境中, 执行附录十第2.1.所述的调查时所使用的任何器械.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorized to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;其他具专业资格的人员经授权执行此种临床调查将视同合格医疗从事人员所执行的临床调查;(f) 'manufacturer' means the natural or legal person with responsibility for the design, manufacture, packaging andlabelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.[制造商]是指器械以其名称上市前, 负责器械的设计, 制造, 包装及贴附标签的自然人或法人, 无论这些设计, 制造等过程是否为自然人或法人亲自执行或委托第三者执行.The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, full refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient;本指令所规定有关制造商的责任亦适用于将一个或一个以上现成的产品加以组装, 包装, 加工, 重新处理及 / 或附加标签而成一器械, 指定其用途并准备以其名称命名上市的自然人或法人. 对于那些非属前一段制造商定义者, 为个别病患的需要拼装或改装已上市销售的器械的情形不适用本段的规定;(g) 'intended purpose' means the use for which the device is intended according to the data supplied by themanufacturer on the labelling, in the instructions and/or in promotional materials;[预期的用途]是指器械须依照制造商于标签上, 说明书及/ 或促销宣称中提供的使用条件及资料;(h) 'placing on the market' means the first making available in return for payment or free of charge of a device otherthan a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;[上市]是指为大量行销及 / 或于共同体市场使用的目的, 首次以金钱交易或免费赠送方式提供非临床调查用全新或重新处理过的器械的行为;(i) 'putting into service' means the stage at which a device is ready for use on the Community market for the firsttime for its intended purpose.[开始使用]是指某一器械在共同体市场首次可依原订的用途开始使用的时期.3. Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive65/65/EEC, that device shall be governed by the present Directive, without prejudice to the provisions of Directive' 65/65/EEC with regard to the medicinal product.对于用来管理65/65/EEC号指令第一条定义的医疗产品的器械, 在不侵害65/65/EEC号有关医疗产品指令条款的规定下, 该类器械应受本指令规范.If, however, such a device is placed on the market in such a way that the device and the medicinal product forma single integral product which is intended exclusively for use in the given combination and which is not reusable,that single product shall be governed by Directive 65/65/EEC. The relevant essential requirements of Annex I to the present Directive shall apply as far as safety and performance related device features are concerned.但是, 假若某种器械须与其他医疗产品组合成一完整的产品而上市销售使用, 且无法二次使用时, 该组合产品应受65/65/EEC号指令规范. 本指令附录一所列有关器械安全及性能方面的相关基本要求仍然适用.4. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered tobe a medicinal product within the meaning of Article 1 of Directive 65/65/EEC and which is liable to act upon the body with action ancillary to that of the device, that device must be assessed and authorized in accordance with this Directive.如果医疗器械包含某项医疗物质, 而该物质单独使用时符合65/65/EEC号指令第一条对医疗产品的定义, 且可能对人体产生作用以辅助医疗器械的作用时, 该器械应依照本指令的规定加以评鉴并授权.5. This Directive does not apply to:本指令不适用于下列器械:(a) in vitro diagnostic devices;体外诊断器械;(b) active implantable devices covered by Directive 90/385/EEC;受90/385/EEC号指令规范的主动植入式医疗器械;(c) medicinal products covered by Directive 65/65/EEC;受65/65/EEC号指令规范的医疗产品(d) cosmetic products covered by Directive 76/768/EEC;受76/768/EEC号指令规范的化妆品;(e) human blood, human blood products, human plasma or blood cells of human origin or to devices whichincorporate at the time of placing on the market such blood products, plasma or cells;人类的血液, 血液产品, 血浆或血球, 或者上市时包含人类血液产品, 血浆或血球的器械;(f) transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells ofhuman origin;人类的移植器官, 组织或细胞及包含或由人类组织, 细胞产生的产品;(g) transplants or tissues or cells of animal origin, unless device is manufactured utilizing animal tissue which isrendered non-viable or non-viable products derived from animal tissue.动物的移植器官, 组织或细胞; 但利用死的动物组织或其产品而制造的器械则不在此限.6. This Directive does not apply to personal protective equipment covered by Directive 89/686/EEC. In decidingwhether a product falls under that Directive or the present Directive, particular account shall be taken of the principal intended purpose of the product.本指令不包括受89/686/EEC号指令规范的个人保护装备. 而要决定某产品应受该指令规范亦受本指令规范时, 必须特别考虑该产品设计的主要目的.7. This Directive is a specific Directive within the meaning of Article 2 (2) of Directive 89/336/EEC.本指令是89/336/EEC号指令第二条第2项中所述的特定指令.8. This Directive does not affect the application of Directive 80/836/Euratom, nor of Directive 84/466/Euratom.本指令不影响80/836/Euratom指令及84/466/Euratom 指令的实施.Article 2第 2 条Placing on the market and putting into service上市及使用Member States shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they do not compromise the safety and health of patients, users and, where applicable, other persons when properly installed, maintained and used in accordance with their intended purpose.各会员国必须采取所有必要的措施, 以确保器械依其设计的目的安装, 维护及使用时不会牺牲病患, 使用者或, 适用时, 其他人员的安全及健康后方可上市.Article 3第 3 条Essential requirements基本要求The devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned.器械依其设计的目的必须符合附录一所列适用的基本要求, 并顾及器械原先预期的用途.Article 4第 4 条Free movement, devices intended for special purposes自由流通及特殊目的的器械1. Member States shall not create any obstacle to the placing on the market or the putting into service within theirterritory of devices bearing the CE marking provided for in Article 17 which indicate that they have been the subject of an assessment of their conformity in accordance with the provisions of Article 11.各会员国在其领土内不得对附加第十七条所述CE标示器械的上市及使用设立任何障碍, CE 标示代表该器械已依第十一条的规定经过符合评鉴的程序.2. Member States shall not create any obstacle to:对于下列器械会员国不得设有任何障碍:- devices intended for clinical investigation being made available to medical practitioners or authorized persons for that purpose if they meet the conditions laid down in Article 15 and in Annex VIII,符合第十五条及附录八规定, 供医疗从业人员或经授权的人员执行临床调查而制造的器械- custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII.符合第十一条及附录八规定上市及使用的订制器械; 属于第IIa, IIb, 及III类器械须附有附录八所提的说明资料.These devices shall not bear the CE marking.上述器械无需附加CE标示.3. At trade fairs, exhibitions, demonstrations, etc. Member States shall not create any obstacle to the showing ofdevices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices cannot be marketed or put into service until they have been made to comply.对于未符合本指令的器械, 但有明显的标识说明该器械在未符合本指令的规定前不可上市销售或使用时, 各会员国不得妨碍其于商展中展示.4. Member States may require the information, which must be made available to the user and the patient inaccordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use.会员国得要求专业或非专业用途的医疗器械, 其依附录一第13点规定供使用者及病患使用的相关资讯必须以该国语言或其他共同体语言书写.5. Where the devices are subject to other Directives concerning other aspects and which also provide for theaffixing of the CE marking, the latter shall indicate that the devices also fulfil the provisions of the other Directives.若某器械在其他方面亦受到其他指令的规范, 且该等指令同时包含CE标示附加的说明, 则其CE标示表示该器械亦符合其他指令的条款.However, should one or more of these directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the devices fulfil the provisions only of those directives applied by the manufacturer. In this case, the particulars of these directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the directives and accompanying such devices.。
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）。
欧盟医疗器械CE认证技术文档编写Technicalfileeditting
Module 3 – CE技术文档编写
技术文档的语言
? 如果欧盟指令未包括对文档语言的特 别规定时，生产者必须对成员国的需 求进行评估。
? 可能不会出现更多状况来影响到相关 的翻译件。 (例如经过验证的)
13
Module 3 – CE技术文档编写
技术文档－第一部分
包括与符合性评价程序有关的，最重要 技术数据： ? 制造商信息 ? 欧洲代表信息 ? 质量系统所涉及的全部制造场所的清
19
示例
6．设计验证
如果生产者能证明这些年来市场验证后是一 种安全设计且其性能按设计要求，则不需要。
否则，按如下步骤提供文件：
－设计合格检验
－关于预期用途的设计预测（如果有关，参 考其他产品）
7．风险分析
－器械的风险评估
20
示例
8．符合基本要求和调查标准
－列出所有使用的调整标准或，如果使用不 完整，详细叙述如何满足基本要求。
物理性能报告
? 不同的产品有不同的物理性能
? 例如：带针注射器
尺寸
针管韧性和刚性
推拉力
器身密合性
残留容量
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化学性能报告
? 不同的产品有不同的化学性能
? 例如：带针注射器
酸碱度Βιβλιοθήκη 可萃取金属含量易氧化物环氧乙烷残留(生物性能)
53
可用性报告
? EN 62366:2008
54
EMC测试报告 电气安全测试报告
綠色能源 利用自然，開發綠色能源
綠色生活 讓環保融入您生活的各個層面
綠色產品 更低的環境影響， 帶來更高的市占率
綠色循環 負責的回收再利用
始於產品設計
德國萊因 綠色解決方案
ce 医疗器械使用说明书
ce 医疗器械使用说明书
CE认证的医疗器械使用说明书应包括以下内容：
1. 器械的预期用途：明确说明器械的适应症、禁忌症、患者目标群体和预期用户。
2. 临床收益规范：如适用，提供预期的临床收益规范。
3. 器械的性能特征：详细描述器械的性能特点，以便医疗保健专业人员了解器械的特性和功能。
4. 软件和附件选择：如适用，提供信息用于医疗保健专业人员验证器械是否合适，并选择相应的软件和附件。
5. 剩余风险、禁忌症和不良副作用：明确说明任何剩余风险、禁忌症和任何不良副作用，包括传达给患者的关于这方面的信息。
6. 使用者要求：说明使用者要求适当使用该装置的规格，例如，若器械具有测定功能，提供其所要求的准确度。
7. 预处理或处理细节：在准备使用之前或在其使用（例如，灭菌、最终组装、校准等）期间器械的任何预处理或处理的细节，包括确保患者安全所需的消毒水平和实现所需消毒水平所需的所有可用方法。
8. 特定资格要求：说明对特殊设备、特殊培训或设备用户和/或其他人的特
定资格的任何要求。
以上内容仅供参考，具体应基于制造商的风险管理文档的特定部分，详细说明这些特征和技术因素。
欧盟医疗器械CE认证技术文档编
欧盟医疗器械CE认证技术文档编
首先，技术规格是文档的基础，它包含了产品的功能和性能要求，以
及标准和法规的引用。
技术规格应该根据相关的法规和标准来编写，明确
产品的设计目标和技术要求。
其次，设计文件是产品开发过程中的重要文件，包括了产品的整体设计、系统和组件设计，以及相关的风险控制措施和测试计划等。
设计文件
要详细描述产品的结构和功能，以便于后续的验证和评估。
验证是产品开发和认证过程中必不可少的一步，它用于确认产品符合
技术规格和设计文件的要求。
验证的内容包括性能测试、电磁兼容性测试、生物兼容性测试等。
验证报告是验证过程中产生的文件，记录了测试过程、结果和结论，以及对测试结果的评估和建议。
最后，技术文件是医疗器械CE认证的重要组成部分，它是对产品设计、验证和评估过程的总结和记录。
技术文件要包含所有必要的信息和数据，以便于监管机构对产品进行评估和审核。
技术文件的具体要求由欧盟
医疗器械指令规定，并根据具体的产品类型和风险等级进行调整。
总结起来，欧盟医疗器械CE认证技术文档编写是一个复杂而繁琐的
工作，需要对法规和标准有深入的了解，以及严谨的技术和工程能力。
编
写技术文件需要仔细、准确地记录产品的设计和验证过程，以及风险评估
结果和控制措施。
只有通过严格的技术文档编写和审核，才能确保产品符
合欧盟相关法规和标准的要求，获得医疗器械CE认证。
医疗器械CE技术文件管理规范
医疗器械CE技术文件管理规范引言：一、技术文件的内容1.产品描述和标识：包括产品名称、型号、规格、用途、标志等。
2.设计和制造的描述：包括设计说明书、原材料清单、制造工艺等。
3.验证和验证文件：包括关于原材料、制造工艺、产品性能和使用安全的验证报告。
4.环境和性能测试文件：包括产品耐力测试、防护性能测试、材料耐受性测试等。
5.标准和规范文件：包括适用的国际和欧盟标准、技术规范和法规等。
6.安全性评估：包括生物相容性、电磁兼容性、机械安全性等评估报告。
7. Instructions for Use (IFU) 文件：包括产品使用说明、操作方法、安全注意事项等。
8.风险分析和评估：包括对产品可能带来的使用风险和所采取的风险控制措施的分析和评估报告。
9.品质体系文件：包括公司的品质管理体系、生产和质量控制流程等。
二、技术文件的管理流程1.文件编制：相关责任人员明确编制技术文件的责任和进度安排。
3.文件更新：及时更新技术文件，确保文件的准确性和及时性。
4.文件存档：建立文件存档管理系统，确保技术文件的安全可靠。
5.文件审查：定期对技术文件进行审查，确保文件的有效性和合规性。
6.文件保管：负责人制定相应的文件保管措施，确保技术文件的机密性和完整性。
三、规范要求1.文件的编写应准确、完整、统一、一致，并确保易于理解和使用。
2.技术文件中的内容应能够充分证明产品符合CE标准的要求。
3.技术文件应依据医疗器械CE指令要求编制，并标明适用的指令和标准。
4.技术文件的更新应及时，确保文档内容和实际产品的一致性。
5.技术文件应妥善存档并保密，防止文件被非法获取、篡改或损毁。
6.技术文件的审查应定期进行，及时发现和修正文件中的错误和缺漏。
7.技术文件的保管应建立相应的控制措施，确保文件的完整性和可追溯性。
结论：医疗器械CE技术文件的管理规范对于确保产品符合CE标准的要求至关重要，正确编制、更新和保管技术文件是保证产品合规性的基础。
CE技术文件指南NB-MED2[1].5.1(中文)资料
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产品技术文档推荐NB-MED/2.5.1/Rec5 章节： 2.5.1 符合性评估程序；总则关键词：设计档案，技术文档，技术档案1.介绍对技术文档的要求在医疗器械指令的不同附件多有提及，适当时用于符合性评估程序和涉及到的产品。
作为总则，该文档应包括产品的设计、制造和产品的操作。
备注：产品的“操作” 包括安装、使用准备、用前检查和维护、校准以及对特殊医疗器械的服务。
文档所包含的具体细节决定于产品的特性和必要的关注点。
从技术角度来看，就是陈述产品符合对医疗器械指令本质要求。
如果使用了该统一标准，技术文档应该明确这些用于说明符合实质要求的哪里是被该标准覆盖的。
注：该推荐标准特为满足医疗器械和有源植入式医疗器械的技术文档的指导需要而写。
该推荐标准也许也是有用的，然而，涉及到体外诊断医疗器械，但是可能根据体外诊断医疗器械指令的实际实施的经验需要修正。
2.目的一份原理和历史页是需要的，请联系技术秘书处。
该推荐标准的目的是向认证方、主管当局和生产商在需要满足医疗器械指令要求的技术文档方面提供指导。
备注：迫使生产商修改现有的已证明适合和充分的技术文档不是该推荐标准的目的。
3.技术资料3.1综述主题指导（ⅰ）技术文档内该推荐标准不是欲详尽罗列所有特殊情况可能需要的技术文档的列表。
容也就是，一些特殊的资料没有没包括近来，而此处会提供一个正当的说法。
指令要求生产商准备技术文档进行确定和证明什么是适宜的和充分的，而确保他的医疗器械符合相关指令。
这在不同的情况有明显的不用，取决于产品的种类、制造随附的风险、安装使用和服务，以及其在市场上的时期。
比如，所有的已有产品，不管类别都有非常正视的设计验证是不可能的。
但是生产商在使用经验和他如何应对出现的问题上都有丰富的经验，这些资料都应用于验证方面。
ⅱ）其他技术文档应包括3.2-3.5 部分所阐述的资料3.2 产品描述主题ⅰ）器械的概括描述指导包括变化范围（比如，只有长度不同的同一型号的一组导管），和有关器械性能和特性储存的包装描述。
(完整word版)医疗器械注册申报资料要求及说明
有关产品包装的信息，以及与该产品一起销售的配件包装情况；对于无菌器械，应说明与灭菌方法相适应的最初包装的信息。
（五）预期用途和禁忌症
1.预期用途：应明确产品所提供的治疗或诊断功能，并描述其适用的治疗阶段，目标用户和用户操作该产品应具备的技能/知识/培训；使用方式：一次性使用还是重复使用。
附件3
医疗器械注册申报资料要求及说明
一、申请表
应按照要求完整填写注册申请表。
二、医疗器械安全有效基本要求清单（见附件9）
三、综述资料
（一）概述
简单描述申报产品的管理类别、分类编码及名称的确定依据、预期用途、使用环境、适用人群等信息。
（二）产品描述
1.无源医疗器械
应包括工作原理、结构组成（含配合使用的附件）及图示、制造材料、包装材料、型号规格及其划分依据、主要生产工艺、交付状态及作用机理等内容。产品如有区别于其他同类产品的特征也应加以描述。详细描述所有与人体接触部件的制成材料清单，包括规格/化学特性。
2.预期使用环境：该产品预期使用的地点如医院、医疗/临床实验室、救护车、家庭等，以及可能会影响其安全性和/或性能的环境条件（例如，温度、湿度、功率、压力、移动等）；
3.适用人群：目标患者人群的信息（如成人、儿童或新生儿），患者选择标准的信息及使用过程中需要监测的相关参数；
4.禁忌症：由于可能产生不良事件或风险，应明确说明该器械禁止使用的疾病或情况。
对于含有同种异体材料、动物源性材料、药物成分或生物活性物质等的产品，应予以明确说明，包括来源、特性、使用的原因及其主要作用方式。
2.有源医疗器械
详细描述产品结构组成(含配合使用的附件)、主要功能、工作原理、作用机理(如适用)以及各组成部件(关键组件和软件)的功能，并详细描述关键元器件。应足够详尽并提供图示说明，产品如有区别于其他同类产品的特征也应加以描述。详细描述所有与人体接触部件的制成材料清单，包括规格/化学特性。
CE 认证的全套技术文件(新)
XXXX有限公司CE技术文件清单文件编号：AMS/CE,JS-2015版次号： A/0受控状态：受控分发编号：发布日期：2014年8月1日生效日期：2013年08月15日XXXX有限公司发布CE技术文件清单受控状态 AMS/CE.JS-02公司简介企业概况受控状态 AMS/CE.JS-03关于欧洲代表声明关于确定欧洲代表的声明本公司目前无产品销售到欧洲地区，也无确定欧洲代表，今后在产品出口欧洲之前确定好欧洲商及欧洲代表地址等，然后通知认证公告机构。
职位签名日期受控状态 AMS/CE.JS-04产品描述一、产品性能特性:“”(商品名:)是由有限公司根据市场和临床治疗的需要,产品中以无机生物活性材料为主要原料而研发生产的促进创面修复的医疗产品。
当“”产品与创面组织接触时，其中具有生物活性的无机生物活性材料与组织发生离子交换，提高创面局部的氧分压和PH值，在表面形成较强的负电势，并通过一系列生化反应，形成一个羟基磷灰石（HCA）组成的多孔网状结果组织，能吸附大量与组织再生有关的各种物质，使新生组织得以顺利爬移。
从而达到加速创面愈合的作用。
二、产品适用范围：“******”(商品名:******)适用与各种手术及外伤造成的创面，皮肤溃疡及褥疮以及浅Ⅱ度烧、烫伤的创面愈合。
三、产品主要技术性能及参数：1、产品命名：1．1产品通用名：******1．2产品商品名：******2、产品成份：2．1粉状产品由组成2、2膏状产品由组成3、产品形式与规格：3．1产品形式：膏状、粉状3．2产品规格:1）粉状：2）膏状：，3）4、主要技术性能及参数:4、1产品外观:粉状产品为。
膏状产品为。
4、2产品装量:粉状产品装量应符合下表规定膏状产品装量应符合下表规定4、3粒度:粉状产品：。
膏状产品：。
4、4重金属含量:产品重金属的含量不大于30mg/Kg。
4、5炽灼残渣:粉状产品炽灼残渣≥90﹪(W/W)。
膏状产品炽灼残渣≥20﹪(W/W)。
CE技术文件指南NB-MED2[1].5.1(中文)
![CE技术文件指南NB-MED2[1].5.1(中文)](https://img.taocdn.com/s3/m/fde9a31c79563c1ec5da716d.png)
产品技术文档推荐NB-MED/2.5.1/Rec5 章节：2.5.1符合性评估程序；总则关键词：设计档案，技术文档，技术档案1.介绍对技术文档的要求在医疗器械指令的不同附件多有提及，适当时用于符合性评估程序和涉及到的产品。
作为总则，该文档应包括产品的设计、制造和产品的操作。
备注：产品的“操作”包括安装、使用准备、用前检查和维护、校准以及对特殊医疗器械的服务。
文档所包含的具体细节决定于产品的特性和必要的关注点。
从技术角度来看，就是陈述产品符合对医疗器械指令本质要求。
如果使用了该统一标准，技术文档应该明确这些用于说明符合实质要求的哪里是被该标准覆盖的。
注：该推荐标准特为满足医疗器械和有源植入式医疗器械的技术文档的指导需要而写。
该推荐标准也许也是有用的，然而，涉及到体外诊断医疗器械，但是可能根据体外诊断医疗器械指令的实际实施的经验需要修正。
2.目的一份原理和历史页是需要的，请联系技术秘书处。
该推荐标准的目的是向认证方、主管当局和生产商在需要满足医疗器械指令要求的技术文档方面提供指导。
备注：迫使生产商修改现有的已证明适合和充分的技术文档不是该推荐标准的目的。
3.技术资料3.1综述主题指导（ⅰ）技术文档内容（ⅱ）其他该推荐标准不是欲详尽罗列所有特殊情况可能需要的技术文档的列表。
也就是，一些特殊的资料没有没包括近来，而此处会提供一个正当的说法。
指令要求生产商准备技术文档进行确定和证明什么是适宜的和充分的，而确保他的医疗器械符合相关指令。
这在不同的情况有明显的不用，取决于产品的种类、制造随附的风险、安装使用和服务，以及其在市场上的时期。
比如，所有的已有产品，不管类别都有非常正视的设计验证是不可能的。
但是生产商在使用经验和他如何应对出现的问题上都有丰富的经验，这些资料都应用于验证方面。
技术文档应包括3.2-3.5部分所阐述的资料3.2 产品描述主题指导（ⅰ）器械的概括描述 包括变化范围（比如，只有长度不同的同一型号的一组导，和有关器械性能和特性储存的包装描述。
(完整版)CE认证的全套技术文件
受控状态CE.JS-01CE 文件清单拟制日期 2014 年5 月17 日审核日期 2014 年5 月17 日批准日期 2014 年5 月17 日版号 A 生效日期2014 年8 月1 日XX 有限公司受控状态CE.JS-02企业简介拟制日期 2014 年5 月17 日审核日期 2014 年5 月17 日批准日期 2014 年5 月17 日版号 A 生效日期2014 年8 月1 日XX 有限公司企业概况受控状态CE.JS-03 关于欧洲代表声明拟制日期 2014 年5 月17 日审核日期 2014 年5 月17 日批准日期 2014 年5 月17 日版号 A 生效日期2014 年8 月1 日XX 有限公司关于确定欧洲代表的声明本公司欧洲代表是 XX，地址：XXX，联系方式:XXX。
特此确定声明！职位签名日期受控状态CE.JS-04产品描述拟制 ****** 日期 2014 年5 月17 日审核 ****** 日期 2014 年5 月17 日批准 ****** 日期2014 年5 月17 日版号 A 生效日期 2014 年8 月1 日XX 有限公司产品描述一、产品性能特性:“”(商品名:)是由有限公司根据市场和临床治疗的需要,产品中以无机生物活性材料为主要原料而研发生产的 XXX 医疗产品。
当 XXX 产品与创面组织接触时，其中具有生物活性的无机生物活性材料与组织发生离子交换，提高创面局部的氧分压和 PH 值，在表面形成较强的负电势，并通过一系列生化反应，形成一个羟基磷灰石（HCA）组成的多孔网状结果组织，能吸附大量与组织再生有关的各种物质，使新生组织得以顺利爬移。
从而达到加速创面愈合的作用。
二、产品适用范围：“******”(商品名:******)适用与各种手术及外伤造成的创面，皮肤溃疡及褥疮以及浅Ⅱ度烧、烫伤的创面愈合。
三、产品主要技术性能及参数：1、产品命名：1．1 产品通用名：******1．2 产品商品名：******2、产品成份：2．1 粉状产品由组成2、2 膏状产品由组成3、产品形式与规格：3.1产品形式：膏状、粉状3.2产品规格:1）粉状：2）膏状：，3）4、主要技术性能及参数:4、1 产品外观:粉状产品为。
（完整版）无源医疗器械研究资料-模板
（完整版）无源医疗器械研究资料-模板研究资料（一）产品性能研究1、xxxx是由公司开发并生产的新产品，该产品使用方便。
根据国家药品监督管理局xxxx年x月下发的《医疗器械分类目录》规定，本品属“68xx xxxx器械”，管理类别为x类医疗器械。
2、主要技术指标2.1 外观组成：2.2 尺寸2.3 材料2.4 物理性能2.5 化学性能.........3、性能指标的依据1）外观组成，根据使用要求制定；2）尺寸，根据xxxx标准制定；.........4、标准及参考文献标准列表（二）生物相容性评价研究生物相容性评价研究评价者：评价产品：一次性使用配药用注射器1、生物相容性评价的依据和方法该评价是对公司生产的xxxx产品进行的医疗器械生物学评价，所有产品采用同样的材料进行生产。
根据GB/T16886.1提供的生物学评价流程图制定本产品的生物学评价方法选择流程图为：2、结论公司生产的xxxx产品属非接触人体器械，使用时间为＜24h，产品用于临床抽取或配置药液，无需进行材料的生物相容性评价。
（三）生物安全性研究本品不含同种异体材料、动物源性材料或生物活性物质等，不是有生物安全风险类产品，不用提供相关材料及生物活性物质的生物安全性研究资料。
（四）灭菌/消毒工艺研究1、研究依据本品属于无菌类产品，含xxxx组件组成，采用环氧乙烷灭菌。
参照GB18279-2000医疗器械环氧乙烷灭菌确认和常规控制要求进行一次性使用配药用注射器的环氧乙烷灭菌，由ISO11135-1：2007验证试验与相关资料，以保证满足一次性医疗器械的无菌要求。
2、灭菌工艺的研究2.1 生物负载xxxx产品的初始污染菌为5.1（平均生物负载）。
根据GB18279-2000、ISO11135-1：2007和初始污染菌（平均生物负载），确定灭菌剂充入量、操作温度、湿度控制、真空度、灭菌时间及换气排残指标。
2.2 灭菌剂充入量根据GB18279-2000附录A3.2.2和附录C3.1，选择浓度30％的环氧乙烷（EO），设定xxxx 产品的环氧乙烷灭菌值为0.5kg/m3（相当于500mg/L）。
最新MDR一类医疗器械全套技术文件模板(中英文对照)
最新MDR一类医疗器械全套技术文档模板（中英文对照）CE TECHNICALDOCUMENTATION Based on REGULATION (EU) 2017/745Product Name: {填写申报产品名称}Model:{填写申报产品的具体型号}Document No.: {填写本文档编号}Edition: {填写本文档版本号}{填写申请者的企业名称}ContentRationale for the qualification as a medical device and the risk class attributedProduct Name:{填写申报产品名称}Model:{填写申报产品的具体型号}Document No.: {填写本文档编号}Edition: {填写本文档版本号}Drafted by: Date: {填写本文档编写日期}Checked by: Date: {填写本文档审核日期}Approved by: Date: {填写本文档批准日期}{填写申请者的企业名称}Revision records:1.Rationale for the qualification as a medical device{填写申报产品可作为器械的合理的理由}【可从产品的预期用途，适应症方面考虑】（参考示例：According to the definition of medical device in REGULATION (EU) 2017/745 as below and the application of{填写申报产品名称}（参考示例：CRP mask）, we consider that{填写申报产品名称}（参考示例：CRP mask）is a medical device.Define of medical device:“medical device” means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:—diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,—diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,—investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,—providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,and which does notachieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.The following products shall also be deemed to be medical devices:—devices for the control or support of conception;—products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.）2.Rationale for the risk class attributed{填写申报产品风险分类的基本原理}（参考示例：The risk class is attributed according to Annex VIII CLASSIFICATION RULES in REGULATION (EU) 2017/745.{填写申报产品名称}（参考示例：CPR mask）is a{填写申报产品的类别}【根据产品实际情况填写申报产品所属类别如是属于非侵入、侵入还是有源】（参考示例：non-invasive）device. The rules of classification for{填写申报产品的类别}【根据产品实际情况填写申报产品所属类别如是属于非侵入、侵入还是有源】（参考示例：non-invasive）devices is in{填写申报产品分类所适用的分类法规}（参考示例：Rule1-Rule4）, the details are as below.{填写申报产品分类所适用的分类法规原文}（4. NON-INVASIVE DEVICES4.1. Rule 1All non-invasive devices are classified as class I, unless one ofthe rules set out hereinafter applies.4.2. Rule 2All non-invasive devices intended for channelling or storingblood, body liquids, cells or tissues, liquids or gases for thepurpose of eventual infusion, administration or introduction intothe body are classified as class IIa:—if they may be connected to a class IIa, class IIb or class IIIactive device; or—if they are intended for use for channelling or storing blood or other body liquids or for storing organs, parts of organs or body cells and tissues, except for blood bags; blood bags are classified as class IIb.In all other cases, such devices are classified as class I.4.3. Rule 3All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, otherbody liquids or other liquids intended for implantation or administration into the body are classified as class IIb, unless thetreatment for which the device is used consists of filtration,centrifugation or exchanges of gas, heat, in which case they areclassified as class IIa.All non-invasive devices consisting of a substance or a mixtureof substances intended to be used in vitro in direct contact withhuman cells, tissues or organs taken from the human body orused in vitro with human embryos before their implantation oradministration into the body are classified as class III.4.4. Rule 4All non-invasive devices which come into contact with injuredskin or mucous membrane are classified as:—class I if they are intended to be used as a mechanical barrier,for compression or for absorption of exudates;—class IIb if they are intended to be used principally for injuriesto skin which have breached the dermis or mucous membraneand can only heal by secondary intent; —class IIa if they are principally intended to manage themicro-environment of injured skin or mucous membrane; and—class IIa in all other cases.This rule applies also to the invasive devices that come intocontact with injuredmucous membrane.）According to above rules, {填写申报产品名称}（参考示例：CPR mask）is classified as Class I according to{填写产品适用的分类规则}（参考示例：rule 1）.）Description and specificationProduct Name:{填写申报产品名称}Model:{填写申报产品的具体型号}Document No.: {填写本文档编号}Edition: {填写本文档版本号}Drafted by: Date: {填写本文档编写日期}Checked by: Date: {填写本文档审核日期}Approved by: Date: {填写本文档批准日期}{填写申请者的企业名称}Revision records:1 product or trade name and a general description of the device including its intended purpose and intended users;1.1 Name of the DeviceProduct name: {填写申报产品名称}1.2 Product description{对产品进行简要描述}【可从产品的组成，是否含附件以及所属的类别，是否需要灭菌等方面，进行简要描述】1.3 Intended Purpose{填写申报产品的预期用途}1.4 Intended User{填写申报产品的目标使用者}（参考示例：hospital staff）2 The intended patient population and medical conditions to be diagnosed, treated and/or monitored and other considerations such as patient selection criteria, indications, contra-indications, warnings;2.1 Intended patient population{填写产品适用的患者人群}（参考示例：adult）2.2 Medical conditions{填写产品适用的疾病阶段或程度}(参考示例：The patient requires ventilation)2.3 Other considerations2.3.1 Patient selection criteria{填写申报产品适用的病人的选择标准}（参考示例：the years old of patient over18）2.3.2 Indications{填写申报产品的适应症}2.3.3 Contra-indications,{填写申报产品的禁忌症}2.3.4 Warnings{填写申报产品的警告}3 Principles of operation of the device and its mode of action, scientifically demonstrated if necessary3.1 Principles of operation{填写申报产品的操作原理}3.2 Mode of action{填写申报产品的作用方式}4 The rationale for the qualification of the product as a devicePlease refer to Document 1 “Rationale for the qualification as a medical device and the risk class attributed”.5 The risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII;Please refer to Document 1 “Rationale for the qualification as a medical device and the risk class attributed”.6 An explanation of any novel features;{填写申报产品是否使用新技术的描述} （参考示例：This is a traditional technology. It has been used all over the world for many years. There are no novel features.）7 A description of the accessories for a device, other devices and other products that are not devices, which are intended to be used in combination with it;{对申报器械是否有附件，以及预期与其他非器械联合使用的简要描述} （参考示例：The actual device do not contain accessories. It is not used in combination with other devices.）8 A description or complete list of the various configurations/variants of the device that are intended to be made available on the market;{详细列出申报产品的所有的型号，并描述各型号之间的差异 }9 A general description of the key functional elements9.1 Its parts/components (including software if appropriate)9.1.1 Parts/ComponentsThe parts of {填写申报产品名称} are as below.{列出申报产品组件 }9.1.2 Software{此处对申报产品的软件进行描述}.9.2 FormulationIt is consisted of components as section 9.1.1. It does not contain special formulation.9.3 Its compositionPlease refer to section 10.1.1.9.4 Functionality{对关键原件的功能进行描述}9.5 qualitative and quantitative composition.{对关键元件的定性和定量进行描述}9.6 Labelled pictorial representations(e.g. diagrams, photographs, and drawings), clearly indicating key parts/components, including sufficient explanation to underst and the drawings and diagrams;The picture of key parts/components for actual device are as below:{填写申报产品的关键部件的图片或图示}【提供带标记的图形指示关键部件/组件，如图表、照片、图纸等】10 A description of the raw materials incorporated into key functional elements and those making either direct contact with the human body or indirect contact with the body, e.g., during extracorporeal circulation of body fluids;{填写预期与人体间接接触和直接接触的材料说明}（示例见下文，包括不限于下列表格中的内容）11 Technical specifications{对申报产品的技术规格进行描述}【包括但不限于特征、尺寸、性能属性，通常出现在用户阅读的产品规范中，例如宣传册、目录、相似出版物等】Technical SpecificationsProduct Name:{填写申报产品名称}Model:{填写申报产品的具体型号} Document No.: {填写本文档编号}Edition: {填写本文档版本号}Drafted by: Date: {填写本文档编写日期}Checked by: Date: {填写本文档审核日期}Approved by: Date: {填写本文档批准日期}{填写申请者的企业名称}Revision records:1.Raw materials{填写原材料信息}2.Drawings of components{请详细列出各种组件的图片或图纸}【若有多个组件图片，请依次列出】3. Quality control procedures{对申报产品的质量控制进行简要描述}（参考示例：Our company has established EN ISO 13485 quality system. The manufacture process is continuously monitored.Firstly, the materials are monitored. All incoming suppliers shall be selected by the company in accordance with the requirements of the Supplier management control procedures. When incoming materials of the supplier are delivered to the factory, the quality department shall formulate incoming inspection specifications and conduct incoming inspection in accordance with the inspection requirements. The defective incoming materials shall be handled in accordance with the company's procedure document control procedure for nonconforming products.Secondly, final product is monitored. Before product delivery, the final inspection should be conducted. Meanwhile, deal with the unqualified products according to thecontrol procedure of unqualified products.Thirdly, ex-factory process is monitored.According to the inspection specification, the inspector shall carry out factory inspection on the products, make inspection records and mark the quality status as required, and deal with the unqualified products according to the control procedure of unqualified products.）Information to be supplied by the manufacturerProduct Name:{填写申报产品名称}Model:{填写申报产品的具体型号}Document No.: {填写本文档编号}Edition: {填写本文档版本号}Drafted by: Date: {填写本文档编写日期}Checked by: Date: {填写本文档审核日期}Approved by: Date: {填写本文档批准日期}{填写申请者的企业名称}Revision records:er Manual and Label{放入申报产品的使用手册和标签}（参考示例：Please refer to***User Manual and ***Label.）{请放入申报产品的说明书}【对申报产品的说明书要求请参考MDR 法规第附录I第III章中对说明书，以及EN ISO 15223-1:2016标准中对说明书的要求】{请放入申报产品的标签}【对申报产品的标签的要求请参考MDR 法规第附录I第III章中对标签，以及EN ISO 15223-1:2016标准中对标签的要求】Reference to previous generations of the device andto similar devicesProduct Name:{填写申报产品名称}Model:{填写申报产品的具体型号}Document No.: {填写本文档编号}Edition: {填写本文档版本号}Drafted by: Date: {填写本文档编写日期}Checked by: Date: {填写本文档审核日期}Approved by: Date: {填写本文档批准日期}{填写申请者的企业名称}Revision records:1.An overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist{若申报产品有前代产品的话，请对前代产品进行简要概述}【参考示例：The actual device is the First-generation products, we consider there is no previous generation 】2. An overview of identified similar devices available on the Union or international markets, where such devices exist.{对欧盟以及国际市场上的类似产品进行简要概述}Design and manufacturing informationProduct Name:{填写申报产品名称}Model:{填写申报产品的具体型号}Document No.: {填写本文档编号}Edition: {填写本文档版本号}Drafted by: Date: {填写本文档编写日期}Checked by: Date: {填写本文档审核日期}Approved by: Date: {填写本文档批准日期}{填写申请者的企业名称}Revision records:rmation that allows the understanding of thedesign and manufacturing ofa device1.1Information that allows the understanding of thedesign of a device{填写申报产品的设计开发程序}（参考示例：The actual device are designed according to the Design and development Process as below.）1.2Information that allows the understanding of themanufacturing of a device1.2.1manufacturing processes{列出申报产品的生产程序}1.2.2Process validation{填写生产过程中的各种验证}.【应放入完整的测试数据或链接】(参考示例：The process validation are please refer to * * * Final product test report，* * * Packaging seal validation report)1.2.3 Continuous monitoring{对申报产品生产过程中的连续监测进行描述}（参考示例：Our company has established EN ISO 13485 quality system. The manufacture process is continuously monitored.Firstly, the materials are monitored. All incoming suppliers shall be selected by the company in accordance with the requirements of the Supplier management control procedures. When incoming materials of the supplier are delivered to the factory, the quality department shall formulate incoming inspection specifications and conduct incoming inspection in accordance with the inspection requirements. The defective incoming materials shall be handled in accordance with the company's procedure document control procedure for nonconforming products. Secondly, final product is monitored. Before product delivery, the final inspection should be conducted. Meanwhile, deal with the unqualified products according to the control procedure of unqualified products. Thirdly, ex-factory process is monitored.According to the inspection specification, the inspector shall carry out factory inspection on the products, make inspection records and mark the quality status as required, and deal with the unqualified products according to the control procedure of unqualified products.）1.2.4 Final product testing{列出最终产品的所有验证测试}2 Design calculations relevant to the intended use of the product{填写实现申报产品预期用途的设计原理}.3 Technology{对申报产品的当前技术生产工艺进行简要描述}.（参考示例：From the information of Section 2 of Document 5 Reference to previous generations of the device and to similar devices, the technology of actual device is mature. The design is safe and have been established for a number of years. Actual device have been performing as intended during that time such information is likely tobe sufficient to cover this requirement.）4 Identification of all sites4.1 Company addressThe company registration address：{填写公司注册地址} the manufacturing address：{填写生产地址}.4.2 Supplier addressThe supplier addresses of critical materials are as below:4.3 Sub-contractor address{填写分包商的地址}General safety and performance requirementsProduct Name: {填写申报产品名称}Model:{填写申报产品的具体型号}Document No.: {填写本文档编号}Edition: {填写本文档版本号}Drafted by: Date: {填写本文档编写日期}Checked by: Date: {填写本文档审核日期}Approved by: Date: {填写本文档批准日期}{填写申请者的企业名称}Revision records:1.General safety and performance requirements{放入一般安全和性能要求的符合性证明}（参考示例：Please refer to **** Checklist for General safety and performance requirements Compliance analysis）requirements Compliance analysis REGULATION (EU) 2017/745Conformity Assessment Procedure according to the following Annex of the Directive (pls. tick): Declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19(MDR regulation EU 2017/745) after drawing up the technical documentation set out in Annexes II and III.requirements Compliance analysisPage 3 of 104Page 4 of 104Page 5 of 104Page 6 of 104Page 7 of 104Page 8 of 104Page 10 of 104Page 11 of 104Page 12 of 104Page 14 of 104。
ce技术主文档
ce技术主文档Technical File一次性使用无菌安全自毁型注射器带针Disposal sterile safety & auto-disable syringe,with needle一次性使用无菌注射器带针Disposal sterile syringe,with needleDrafted by：Approved by：Number：Revision：AStatus：ControlledDate：有限公司Co.,Ltd.地址：Address:电话：传真：E-mail：目录第一章：产品简介1.1 生产商信息单位名称：英文：地址：Address:电话：传真：E-mail：联系人：1.2 公司简介有限公司是一家医疗机械专业生产企业。
公司位于村镇，占地面积近两万平米，以生产注射器、输液器等一次性医用耗材为主。
公司环境优美，拥有雄厚的技术力量和先进的生产设备以及精确的检测仪器。
公司将秉承“专业、务实、创新、奉献”的精神，为国内外用户提供产品和服务。
简介写的有点简单，可以增加点：公司的注册资金、人员情况、部门设置、设备情况、生产的产品情况、销售区域等等）1.3、公司组织机构图：Company Organization Structure1.4 关键原材料、供方及认证证书：（证书见附件1 ）1.4.2产品关键件清单注：注射针外购，检验报告见附件1.5 产品描述一次性使用无菌安全自毁型注射器带针Disposal sterile safety & auto-disable syringe,with needle 一次性使用无菌注射器带针Disposal sterile syringe,with needle1.5.1产品主要结构：a)一次性使用无菌安全自毁型注射器带针产品结构：由芯杆、连接座、外套、胶塞、注射针组成。
01—芯杆；02—外套；03—橡胶活塞；04—连接座；05－密封圈；06—注射针；07—注射针护套b)一次性使用无菌注射器带针产品结构：由芯杆、外套、胶塞、注射针组成。
guidance-technical-documentation-and-design-dossiers
Whereas the term “Technical Documentation” or “Technical File“ is used for medical devices of class I, class IIa, andclass IIb, the term “Design Dossier“ is used for class III products.术语“技术文档”或“技术文件”用于医疗设备的I类，IIA类和IIB类，术语“设计档案”用于第三类产品。
Technical Documentation is retained in the premises of the manufacturer or the Authorized Representative for potential review of Competent Authorities and Notified Bodies.技术文件保留在制造商或授权代表处，以备主管部门和公告机构审查。
Part B of the Technical File may be available at the manufacturer only, whereas Design Dossiers have to be submitted to the Notified Body for review prior to CE marking of the product技术文件的B部分可能仅在制造商提供，然而在产品标识"CE"之前，设计档案材料必须提交给认证机构(use form MDD Application for CE Conformity Assessment MED_F_03.15; http://www.tuev-sued.de/industry-and-consumer- products/download-center/applications).（使用MDD应用程序MED_F_03.15进行CE合格评估）We will assign a project coordinator who will entrust one or more further experts with the review of particular modules.我们将指派一个项目协调员，他将委托一个或多个进一步的专家对特定的模块进行评审。
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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。