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此文檔收集于網(wǎng)絡，如有侵權，請聯(lián)系網(wǎng)站刪除COUNCIL DIRECTIVE concerning medical devices關于醫(yī)療器械更改歷史記錄：l M1Directive 98/79/EC of the European Parliament and of the Council of L 331 1 7.12.1998 27 October 1998l M2Directive 2000/70/EC of the European Parliament and of the Council of L 313 22 13.12.200016 November 2000l M3Directive 2001/104/EC of the European Parliament and of the Council L 6 50 10.1.2002of 7 December 2001l M4Regulation (EC) No 1882/2003 of the European Parliament and of the L 284 1 31.10.2003Council of 29 September 2003l M5Directive 2007/47/EC of the European Parliament and of the Council of L 247 21 21.9.20075 September 2007THE COUNCIL OF THE EUROPEAN COMMUNITIES,歐洲共同體理事會Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,依據(jù)歐洲經(jīng)濟體所制訂的羅馬條約, 特別是第 100a 條規(guī)定Having regard to the proposal from the Commission 依據(jù)執(zhí)委會的建議案In cooperation with the European Parliament配合歐洲議會Having regard to the opinion of the Economic and Social Committee, 依據(jù)經(jīng)濟暨社會委員會的意見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;鑒于內(nèi)部市場的完成應采取一些措施; 鑒于內(nèi)部市場是一無內(nèi)部疆界的區(qū)域, 區(qū)域內(nèi)的貨物, 人員, 服務及資金應可自由流通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;鑒于各會員國間現(xiàn)存有關醫(yī)療器械的安全, 對健康的保護及使用特性方面的法律, 法規(guī)及行政命令的內(nèi)容與范圍不盡相同; 鑒于各會員國對此器械的驗證及檢驗程序也不相同; 鑒于前述的分歧將阻礙共同體內(nèi)的貿(mào)易活動;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;鑒于醫(yī)療器械的使用對病患,使用者,甚至其他人有關安全及健康保護的相關國家規(guī)定應加以調(diào)和,以保證此類器械在內(nèi)部市場能自由流通;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;鑒于調(diào)和的規(guī)定必然與各會員國采取的部分措施有所不同, 這些措施是為籌措公共健康與疾病保險計劃的基金, 且直接或間接與醫(yī)療器械有關; 鑒于共同體若與上述措施相符, 則這些規(guī)定并不影響會員國落實上述措施的能力;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 improvementof the level of protection attained in the Member States is one of the essential objectives of this Directive;鑒于醫(yī)療器械應提供病患,使用者及第三者高度的保護,且應該達到廠商所要求的性能水準;鑒于維持或改進各會員國對病患等保護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 CouncilDirective 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;鑒于部分醫(yī)療器械是符合 1965 年 1 月 26 日理事會第 65/65/EEC 號指令,與專賣醫(yī)藥產(chǎn)品有關的法律,法規(guī)或管理行為所訂的實施規(guī)定, 鑒于醫(yī)療器械的上市基本上由本指令規(guī)范, 但醫(yī)療產(chǎn)品的上市則受 65/65/EEC 號指令規(guī)范;鑒于若有某種器械須與其他醫(yī)療產(chǎn)品組成一完整的產(chǎn)品而上市銷售, 使用, 且無法二次使用時,則該組合產(chǎn)品應受65/65/EEC號指令規(guī)范; 鑒于前述的醫(yī)療器械和包含醫(yī)療物質(zhì)且該物質(zhì)單獨使用時符合 65/65/EEC 號指令規(guī)定的醫(yī)療器械應加以區(qū)別; 鑒于前述包含于醫(yī)療器械的醫(yī)療物質(zhì)若對人體產(chǎn)生作用以輔助醫(yī)療器械的作用時, 則該醫(yī)療器械的上市應由本指令規(guī)范;鑒于 1975 年 5 月 20 日 75/318/EEC 號理事會指令制定各會員國在測試專利醫(yī)療產(chǎn)品方面有關分析藥物毒性和臨床的標準及調(diào)查書的法律調(diào)和, 醫(yī)療物質(zhì)的安全,品質(zhì)及效用在前述情況下則須依該指令明定的適當方法加以證實;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;鑒于本指令附錄所訂的基本要求及其他要求,包括最低或降低危險部分的應用,應考慮設計當時的科技及實施情形,并在符合健康和安全高度保護的原則下考慮技術及經(jīng)濟的因素;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; 鑒于為符合 1985 年 5 月 7 日理事會決議中有關技術調(diào)和與標準化新方針所訂定的原則, 有關醫(yī)療器械的設計及執(zhí)照應遵守相關條款以符合基本要求; 鑒于這些要求屬基本要求, 所以應取代對應的國家規(guī)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;鑒于基本要求的落實應謹慎考慮設計當時的科技水準, 并在符合健康和安全高度保護的原則下考慮技術及經(jīng)濟的因素;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;鑒于 1990 年 6 月 20 日通過的 90/385/EEC 號各會員國有關主動植入式醫(yī)療器械法律調(diào)和的理事會指令是第一個應用在醫(yī)療器械方面的新方法指令;鑒于為使共同體規(guī)定適用于所有的醫(yī)療器械,本指令基本上是以 90/385/EEC 號指令的條款為依據(jù); 鑒于 90/385/EEC 號指令,因此也必須增加本指令所列的一般條款的部分;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; 鑒于醫(yī)療器械的電磁相容性是整個產(chǎn)品安全的一部分;鑒于本指令因此須包括 1989 年 5 月 3 日 89/336/EEC 號各會員國有關電磁相容性法律調(diào)和的理事會指令中所制訂的特定規(guī)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; 鑒于本指令應包含釋放電離輻射醫(yī)療器械設計及制造的相關要求;鑒于本指令不影響1980年7月15日80/836/Euratom理事會指令所需要的授權,該指令目的在修訂為保護大眾及工作人員健康,防止電離輻射危險而制訂基本安全標準的其他指令;本指令亦不影響 1984 年 9 月 3 日 84/466/Euratom 號制訂保護人員在醫(yī)療檢查或治療中不受輻射影響的基本方法理事會指令的適用;鑒于 1989 年 6 月 12 日 89/391/EEC 號理事會指令鼓勵改善工作場所中工人的安全與健康及其他相關主題的指令應持續(xù)適用;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;鑒于為證明符合基本要求并使該符合性得以落實,有必要建立調(diào)和的歐洲標準,以避免醫(yī)療器械在設計,制造及包裝上所可能帶來的危險, 鑒于調(diào)和的歐洲標準由私人立法機構制訂, 而且應維持自愿性質(zhì); 鑒于歐洲標準化委員會(CEN) 及歐洲電工標準化委員會(CENELEC)被認為是制訂調(diào)和標準有能力的團體(competent bodies),而此標準符合 1984 年 11 月 13 日執(zhí)委會與上述兩團體所簽訂的合作綱要為基礎的一般指導原則; 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;鑒于為達本指令目的, 調(diào)和標準是前述機構接獲理事會命令后, 依理事會 1983 年 3 月 28 日通過的 83/189/EEC 號指令有關制訂技術標準及法規(guī)資訊提供的程序而采納的技術規(guī)范(歐洲標準或調(diào)和文件,符合前述一般綱要的規(guī)定 ;鑒于調(diào)和標準的修正有賴于 83/189/EE 號指令建立的委員會的協(xié)助;鑒于應采取的措施須依照理事會 87/378/EEC 號指令程序一的規(guī)定; 鑒于特殊領域中現(xiàn)存的歐洲藥典專題論文應納入本指令的架構中; 因此數(shù)篇歐洲藥典專題論文將視其與前述調(diào)和標準有著同等的效力; 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;鑒于理事會在1990 年 12 月 13 日通過的90/683/EEC號有關技術調(diào)和指令適用的符合評鑒程序各階段模式?jīng)Q定中制定調(diào)和的符合評鑒程序; 鑒于這些模式于醫(yī)療器械的應用,可以依相關器械的型式?jīng)Q定制造商及公告機構在符合評鑒程序中應負的責任; 鑒于醫(yī)療器械的證明有必要在模式里增加細節(jié)的規(guī)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;鑒于為達到符合評鑒的目的有必要將醫(yī)療器械分為四類; 鑒于分類是以考慮器械的技術設計及制造對易受傷的人體可能帶來的危險程度為原則;鑒于第 I 類醫(yī)療器械對人體可能產(chǎn)生的傷害較輕微,其符合性評鑒程序大致可由制造商完全負責執(zhí)行; 鑒于對第 II(a)類醫(yī)療器械而言, 在生產(chǎn)階段時公告機構的介入應屬強制性質(zhì); 鑒于屬于第 II(b)類及第 III 類的醫(yī)療器械對人體具有較高的潛在危險,因此在器械的設計及制造階段必須有公告機構的檢驗;鑒于第III類的器械皆為較特別的器械, 其一致性需在上市的前獲得明確授權;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;鑒于器械的一致性如能由制造商負責評鑒,相關主管機關,特別是緊急狀況時,應能聯(lián)絡到一位設于共同體內(nèi)負責將器械在市場上銷售的人員, 該人員可以是制造商本人或其他設于共同體內(nèi)經(jīng)制造商授權的人員;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;鑒于醫(yī)療器械應附加 CE 標志, 表示其符合本指令的條款, 而得以在共同體市場上自由流通并依其設計的目的使用;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;鑒于為抵抗愛滋病, 并顧及理事會于1989 年 5 月 16 日采納有關共同體層次未來防止暨控制愛滋病相關活動的結論, 用于防止 HIV 病毒感染的醫(yī)療器械應提供人體高度的保護; 此類產(chǎn)品的設計及制造應由公告機構的證實;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;鑒于前述的分類原則大多可以適當?shù)貙⑨t(yī)療器械分類; 鑒于醫(yī)療器械性質(zhì)及相關領域技術進步的性質(zhì)各異, 因此必須采取一些措施以決定授予執(zhí)委會的執(zhí)行權力及有關器械的分類或再分類, 或者于適當時調(diào)整分類的原則; 鑒于上述的問題與人員健康的保護有著密切的關聯(lián), 因此這些決議應依照 87/373/EEC 號指令程序 IIIa 規(guī)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;鑒于制造商有責任執(zhí)行臨床調(diào)查以證明其醫(yī)療器械符合安全要求; 因此為保證大眾健康及秩序應明訂執(zhí)行臨床調(diào)查的適當方法;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;鑒于健康的保護及相關的管制方法以在共同體層次上建立一個醫(yī)療裝置警戒系統(tǒng)為最有效;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,鑒于理事會于 1976 年 7 月 27 日通過 76/764/EEC 號有關各會員國水銀玻璃最高溫度計法律調(diào)和的指令中所提及的 醫(yī)療器械亦受本指令規(guī)范;前述指令因此必須撤銷;基于同樣原因,理事會 1984 年 9 月 17 日通過的 84/539/EEC 號指令有關各會員國人類或動物醫(yī)療使用的電動醫(yī)療器械法律調(diào)和,HAS ADOPTED THIS DlRECTIVE:爰制訂本指令:Article 1第 1 條Definitions, scope定義, 范圍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.本指令適用于醫(yī)療器械及其附屬物. 附屬物在本指令的適用范圍內(nèi)亦視其為醫(yī)療器械. 兩者以下皆稱器械.2.For the purposes of this Directive, the following definitions shall apply: 為本指令的目地, 下列定義適用于:(a) M5 medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:醫(yī)療器械 是指制造商預定用于人體以下目的的任何儀器、裝置、器具、材料或其他物品，無論它們是單獨使用還是組合使用，包括製造商預定的用於人體診斷和/或治療目的的軟體及為其正常使用所需的軟體：-diagnosis, prevention, monitoring, treatment or alleviation of disease,診斷, 預防, 追蹤, 治療或減輕疾病,-diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,診斷, 追蹤, 治療或修整傷處或殘障部位,-investigation, replacement or modif