医疗器械CE认证相关问题汇编.doc

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1、【精品文档】如有侵权，请联系网站删除，仅供学习与交流医疗器械CE认证相关问题汇编.精品文档.CE MARKING 相关问题目 录1. 什么是 CE 标志(标记)?- 1 -2. 为什么称 CE 标志(标记) 为产品进入欧盟市场的 “特别通行证”?- 1 -3. CE 标志(标记) 如何影响对欧盟的出口贸易?- 2 -4. 哪些国家要求产品必须携带 CE 标志(标记) ?- 2 -5.哪些产品必须加贴 CE 标志(标记) ?- 3 -6. 哪些为CE认证过程中最常涉及到的欧盟产品指令 Product Directives？- 8 -7. CE 认证包括哪四方面 ？- 9 -8. CE 认证程序-

2、 9 -9关于CE认证中EC(CE)证书的常见问题- 11 -10CE标志后面的号码是什么意思？ 与获证者或其产品有关系吗？- 12 -11Whos going to enforce the requirement for CE Marking?- 12 -12什么是欧盟授权代表(欧盟代表/歐體代表) European Authorised Representative？- 13 -13CE认证时选择欧盟授权代表(欧盟代表)时务必注意什么?- 13 -14为什么您需要一个欧盟授权代表(欧盟授权代理) (Authorized Representative)?- 15 -15为什么欧盟授权代表(欧

3、盟授权代理) Authorized Representative 不同于产品的进口商或销售商 ？- 16 -16CE认证模的9种基本模式- 17 -17我的产品属于医疗器械吗?- 17 -18为什么必须将医疗器械, 体外诊断医疗器械(包括体外诊断试剂)信息注册/通告欧盟主管机关?- 18 -19欧盟的主管机关收取注册费吗?- 19 -20什么时候必须注册/通告主管机关?- 19 -21已通告主管机关的信息变更了，怎么办?- 20 -22经过欧盟注册后，如果制造商名称变了，应该怎么办？- 20 -23体外诊断医疗器械(包括体外诊断试剂)IVD在欧盟注册与通告时应该注意的问题：- 21 -24医疗

4、器械产品出口到欧盟需要注册吗?- 23 -25我公司要做类产品的CE认证, 符合性声明里要写产品型号, 很多类器械都没有型号, 是不是可以不写啊?- 23 -26为什么I类的反而要欧盟代表拿去注册，而II, III类的就不要呢？原因主要有二:- 24 -27谁应该向主管机关申请/注册?- 24 -28医疗器械产品CE认证需要的技术文档- 25 -29基本要求检查表 MDD 93/42/eec Essential Requirements Checklist- 27 -30医疗器械出口欧盟及 EFTA 国家编写标签和说明书涉及的25种官方语言- 28 -31I类医疗器械的CE认证途径- 29 -

5、32IIa类医疗器械的CE认证步骤- 31 -33IIb类医疗器械的CE认证步骤- 33 -34III类医疗器械的CE认证步骤- 34 -35各类医疗器械申请CE的MDD附录?- 35 -36欧盟法律对印制CE标志有何要求?- 36 -37. 各类产品CE认证适用的程序- 37 -1. 什么是 CE 标志(标记)?CE 标志, 又称 CE标记，英文为 CE Marking 是一个30个欧洲国家强制性地要求产品必须携带的安全标志, 其型如 ， 其放大图型如本页顶部中间所示。字母 CE 是法文句子 Conformit Europene 的缩写。其意为 符合欧洲 (标准)。CE 标志(标记) 最初所

6、使用的英文术语为 EC Mark，该术语于1993年签署的欧盟产品指令第93/68/EEC号中正式被术语 CE Marking 所取代。现在，所有的欧盟官方文件中均使用术语 CE Marking。术语 CE Mark 有时也见使用，但是并非官方术语。 1. 一个产品带有CE 标志(标记) 也就意味着其制造商宣告：该产品符合欧洲的健康、安全、与环境保护之相关法律中所规定的基本要求。因而该产品是对: 使用者(译者注：人)，宠物(译者注：家畜家禽)，财产(译者注：物业)，及环境 (译者注：自然环境)都安全的产品。 在实际中，这些法律多以所谓的产品指令(Product Directives)*之方式而

7、发布。 *产品指令通常包含产品必须满足的基本要求essential requirements 或者 性能水平 performance levels 与 协调标准 Harmonized Standards。 协调标准指的是由若干欧洲标准局(CEN, CENELEC, 等)所制定的具体技术规范(也称：欧洲标准 European Standards 或协调文件 Harmonization Documents). CEN 欧洲标准委员会。 CENELEC 欧洲电工技术标准委员会。 2. 一个产品带有CE 标志(标记) 也就是向欧盟盟国的官员表明：该产品可以 合法地进入欧盟统一市场。 3. 一个产品带有

8、CE 标志(标记) 可以确保：该产品可以自由地在欧盟统一市场内流通。 4. 产品(必须)携带CE 标志(标记) (之法规)允许欧盟的： o 海关依法将缺乏CE 标志(标记) 的产品在进入欧盟海关时扣留， o 市场监督机关依法将缺乏CE 标志(标记) 的产品从市场上取缔， o 执法机关依法追究将缺乏CE 标志(标记) 的产品投放市场之个人或公司的法律责任。 随着越来越多的产品指令进入实施阶段，越来越多的产品已经被化入必须携带CE标志(标记) ，否则不准进入欧盟统一市场流通之列。可是，许多非欧盟出口商、制造商仍然没有意识到CE标志(标记) 之重要性，以及CE标志(标记) 对其欧盟出口业务的影响。2

9、. 为什么称 CE 标志(标记) 为产品进入欧盟市场的 “特别通行证”? CE标志相关的欧盟的“产品指令”强制所有成员国制订相应的本国法律。欧盟各成员国制订的与“产品指令”相应的本国法律均要求制造商在产品，包装，及 伴随文件(比如：说明书)上加贴CE标志。一但与CE标志相关的某一欧盟“产品指令”开始强制实施，只有加贴了CE标志的产品才能在市场流通，将缺乏CE标志的产品投放欧盟统一市场将构成违法行为。 制造商有法律责任确保其产品符合相关的欧盟的“产品指令”中的要求并加贴CE标志。CE标志是欧盟为了建立统一市场和促进成员国经济发展而采取的一个重要措施。实施CE标志的目的是为了简化使产品进入欧盟和在

10、其成员国间移动所需的手续，随着越来越多的国家预期加入欧盟，最终导致加贴CE标志的产品可在整个欧洲境内自由移动。因此，欧盟委员会将CE标志看作可使产品在欧洲统一市场内自由流通的通行证。3. CE 标志(标记) 如何影响对欧盟的出口贸易? CE认证的优越性如果任何一个与CE标志相关的产品指令涉及到您的产品，而且您打算出口至30个欧盟和EFTA成员国中的任何一个，那么进行CE认证将是您对欧贸易成功的关键： 通过CE认证，您的产品可以获得一张特别“通行证”，从而可以在30个欧洲国家内自由流通。欧盟东扩后，中国的企业将面对一个更大、运作规则统一的欧洲市场，通过CE认证，只要产品打入欧盟一个成员国，就可以

11、进入其他成员国市场。中国企业在10个新入盟国家的业务相对较多，东扩为这些企业进入欧盟老成员国市场提供了机遇。 CE标志的实施，大大地简化了产品投放欧洲市场的手续，制造商只需要遵守一套法律和要求，亦即欧盟的产品指令即可。而在CE标志的实施之前，制造商若要出口至此30个欧洲国家，不得不遵守每个国家的法律和要求，也就是说，多达20多种法律和要求，不但费时又增加操作成本。 产品通过进行CE认证，使其从设计，生产，包装 各方面更规范，更安全。从而，减少了可能由事故引起的消费者对制造商的起诉。购买保险的费用及售后维护费用也因此而降低。4. 哪些国家要求产品必须携带 CE 标志(标记) ?一共有下列 30

12、(15+10+2+3)个欧洲国家强制性地要求产品携带CE标志. 2004年5月1日前已有的15个欧盟成员国: Austria 奥地利, Belgium 比利时, Denmark 丹麦, Finland 芬兰, France 法国, Germany 德国, Greece 希腊, Ireland 爱尔兰, Italy 意大利, Luxemburg 卢森堡, the Netherlands 荷兰, Portugal 葡萄牙, Spain 西班牙, Sweden 瑞典, United Kingdom (Great Britain) 英国. 2004年5月1日加入欧盟的10个新成员国: Estonia

13、爱沙尼亚, Latvia 拉脱维亚, Lithuania 立陶宛, Poland 波兰, Czech Republic 捷克, Slovakia 斯洛伐克, Hungary 匈牙利, Slovenia 斯洛文尼亚, Malta 马耳他, Cyprus 塞浦路斯. 2007年1月1日加入欧盟的2个新成员国: Bulgaria 保加利亚, Romania 罗马尼亚. 欧洲自由贸易协会 EFTA 的共4个成员国中除瑞士以外的其它3个成员国: Iceland 冰岛, Liechtenstein 列支敦士登, Norway 挪威.5.哪些产品必须加贴 CE 标志(标记) ? 一般地讲，如果您的产品出口到

14、欧盟和欧洲自由贸易协会的30个成员国中的任何一个，并且您的产品属于下列任何一类，您的产品将非常可能需要进行CE认证：1. 燃气炉具 Appliances Burning Gaseous Fuels (AppliGas) The appliances burning gaseous fuels used for cooking, heating, hot water production, refrigeration, lighting or washing and having, where applicable, a normal water temperature not exceedin

15、g 105 gC. Forced draught burners and heating bodies to be equipped with such burners will also be considered as appliances.The gaseous fuel means any fuel which is in a gaseous state at a temperature of 15 gC under a pressure of 1 bar. more 2. 载人的索道装置 Cableway Installations to Carry Persons The cabl

16、eway installations designed to carry persons shall mean installations made up of several components, designed, manufactured, assembled and put into service with the object of carrying persons.These on-site installations are used for the carriage of persons in vehicles or by towing devices, whereby t

17、he suspension and/or traction is provided by cables positioned along the line of travel. . more 3. 低电压电气设备 Low Voltage Electrical EquipmentThe Electrical Equipment means any equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current (A.C.) and between 75 and 15

18、00 V for direct current (D.C.). Therefore, it is called often Low Voltage Electrical Equipment which includes the vast majority of electrical equipment in everyday use. more 4. 建筑产品 Construction Products The construction product means any product which is produced for incorporation in a permanent ma

19、nner in construction works, including both buildings and civil engineering works. more 5. 使用于具有爆炸性环境中的设备和防护系统Equipment and Protective Systems for Used in Potentially Explosive Atmospheres (Atex)o Equipment means machines, apparatus, fixed or mobile devices, control components and instrumentation the

20、reof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy for the processing of material and which are capable of causing an explosion through their own potential sources of ignition. o Pro

21、tective systems means design units which are intended to halt incipient explosions immediately and/or to limit the effective range of explosion flames and explosion pressures. Protective systems may be integrated into equipment or separately placed on the market for use as autonomous systems. o Comp

22、onents means any item essential to the safe functioning of equipment and protective systems but with no autonomous function. Explosive atmospheres Mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapours, mists or dusts in which, after ignition has occurr

23、ed, combustion spreads to the entire unburned mixture.Potentially explosive atmosphere means an atmosphere which could become explosive due to local and operational conditions. . more 6. 民用爆破器材 Explosives for Civil UsesThe Explosives here shall mean the materials and articles considered to be such i

24、n the United Nations recommendations on the transport of dangerous goods and falling within Class 1 of those recommendations. more 7. 燃烧液体或气体燃料的热水锅炉 Hot Water Boilers The hot-water boilers here means a boiler fired by liquid or gaseous fuels with a rated output of between 4 kW and 400 kW (including

25、4 kW and 400 kW). more 8. 家用电冰箱或电冷柜 Household Refrigerators & Freezers more 9. 升降机 LiftThe lift here means an appliance serving specific levels, having a car moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal and intended for the transport of:- per

26、sons,- persons and goods,- goods alone if the car is accessible, that is to say, a person may enter it without difficulty, and fitted with controls situated inside the car or within reach of a person inside. more 10. 机械 Machinery the machinery means: o an assembly of linked parts or components, at l

27、east one of which moves, with the appropriate actuators, control and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material, o an assembly of machines which, in order to achieve the same end, are arranged and c

28、ontrolled so that they function as an integral whole, o interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipme

29、nt is not a spare part or a tool. more 11. 航海设备 Marine EquipmentThe Marine Equipment here means items listed in Directive 96/98/ec Annexes A.1 and A.2 which must be placed on board a ship for use in order to comply with international instruments or are voluntarily placed on board for use, and for wh

30、ich the approval of the flag State administration is required according to international instruments. more 12. (普通)医疗器械 Medical Devices A Medical Device is defined in Directive (93/42/EEC) as: any instrument, apparatus, appliance, material or other article, whether used alone or in combination, incl

31、uding the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of : o diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap. o investigation, replacement or modification of the anatomy or o

32、f a physiological process. o control of conceptionand 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 by such means. more 13. 主动可植入医疗器械 Active Implantable Medical DevicesThe active medical de

33、vice means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravityThe active implantable medical device means any active medical device which is intended to be totally or partially introduc

34、ed, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure. more 14. 体外诊断医疗器械 In Vitro Diagnostic Medical Devices The in vitro diagnostic medical device means any medical device which is a reagent, reagent p

35、roduct, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally fo

36、r the purpose of providing information: - concerning a physiological or pathological state, or - concerning a congenital abnormality, or - to determine the safety and compatibility with potential recipients, or - to monitor therapeutic measures. more 15. 非自动称量仪器 Non-automatic Weighing Instruments A

37、Weighing Instrument is defined as a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters or characteristics. A non-automatic weighing instrumen

38、t is defined as a weighing instrument requiring the intervention of an operator during weighing. more 16. 无线电及电信终端设备 Radio Equipment & Telecommunications Terminal Equipment (R&TTE)more 17. 个人防护设备 Personal Protective Equipment (PPE) The personal protective equipment means any device or appliance desi

39、gned to be worn or held by an individual for protection against one or more health and safety hazards. more 18. 简单压力容器 Simple Pressure Vessels The simple pressure vessel means any welded vessel subjected to an internal gauge pressure greater than 0,5 bar which is intended to contain air or nitrogen

40、and which is not intended to be fired. more 19. 压力设备 Pressure Equipment The Pressure Equipment means vessels, piping, safety accessories and pressure accessories.Where applicable, pressure equipment includes elements attached to pressurized parts, such as flanges, nozzles, couplings, supports, lifti

41、ng lugs, etc.Vessel means a housing designed and built to contain fluids under pressure including its direct attachments up to the coupling point connecting it to other equipment. A vessel may be composed of more than one chamber.Piping means piping components intended for the transport of fluids, w

42、hen connected together for integration into a pressure system. Piping includes in particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or other pressure-bearing components as appropriate. Heat exchangers consisting of pipes for the purpose of cooling or heating air shall

43、be considered as piping.Safety accessories means devices designed to protect pressure equipment against the allowable limits being exceeded. Such devices include:- devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure r

44、elief systems (CSPRS), and- limiting devices, which either activate the means for correction or provide for shutdown or shutdown and lockout, such as pressure switches or temperature switches or fluid level switches and safety related measurement control and regulation (SRMCR) devices.Pressure acces

45、sories means devices with an operational function and having pressure-bearing housings.Assemblies means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole. more 20. 休闲用船只 Recreational CraftThe Recreational craft means any boat of any typ

46、e, regardless of the means of propulsion, from 2,5 to 24 m hull length, measured according to the appropriate harmonized standards intended for sports and leisure purposes. more 21. 玩具 Toys A toy shall mean any product or material designed or clearly intended for use in play by children of less than

47、 14 years of age. more 22. 跨欧洲高速列车系统 Trans-European Conventional Rail System The Trans-European Conventional Rail system means the structure composed of lines and fixed installations, of the trans-European transport network, built or upgraded for conventional rail transport and combined rail transpo

48、rt, plus the rolling stock designed to travel on that infrastructure.6. 哪些为CE认证过程中最常涉及到的欧盟产品指令 Product Directives？CE认证过程中涉及到约30个欧盟产品指令，可分为三类：基本指令、通用指令、和以产品分类的指令。其中最常涉及到的指令有下列4个： 1- 73/23/EEC 低电压电气设备指令 Low Voltage Electrical Equipment (LVD) 1974年8月1日颁布，1997年1月开始为CE标志的强制性指令。低电压电气设备指令适用于工作(输入)电压在交流 50V 至 1000V，或者直流 75V 至 1500V 之间