COUNCIL DIRECTIVE 93/42/EEC
Of 14 June 1993
1993年 6 月 14 日理事會第 93/42/EEC 號指令
concerning medical devices
關(guān)于醫(yī)療器材
THE 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 100 條規(guī)定
Hving regard to the prposal 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 frontier in which the free movement of goods, persons, services and capital is ensured;
鑒于內(nèi)部市場之完成應(yīng)采取一些措施；鑒于內(nèi)部市場是一無內(nèi)部疆界之區(qū)域，區(qū)域內(nèi)之貨品，人員，服務(wù)及資金應(yīng)可自由流通
Whereas the content and scope of the laws, regulations and adrninistrative 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(guān)醫(yī)療器材安全，對健康之保護及使用特性方面之法律，法規(guī)及行政命令之內(nèi)容與范圍不盡相同；鑒于各會員國對此器材之驗證及檢驗程序也不相同；鑒于前述之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 protetion 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 intemal markert;
鑒于醫(yī)療器械之使用對病患，使用者，甚至其他人有關(guān)安全及健康保護的相關(guān)國家規(guī)定應(yīng)加以調(diào)和，以保證此類器材在內(nèi)部市場自由流通；
Whereas the harmonized provisions must be distinguished from the measures adopted by the Member States to manage the funding of jpublic health and sickness insurance schemes relating directly or indirectly to such devices; whereas, therefore,the provisions do nto affect the alility of the Member States to implement the abovementioned measures provided Community law is complied with;
鑒于調(diào)和之規(guī)定必然與各會員國采取之部分措施有所不同，這些措施是為籌措公共健康與疾病保險計劃之基金，且直接或間接與醫(yī)療器材有關(guān)；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 maintenace or improvement of the level of the level of protection attained in the Member States in one of the essential objectives of this Directive;
鑒于醫(yī)療器材應(yīng)提供病患，使用者及第三者高度之保護，且應(yīng)該達(dá)到廠商所要求之性能水準(zhǔn)；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之一；
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 exlusively for use in the given combination and which is not reusable, that single-umit product shall be govemed by Directive 65/65/EEC; whereas a distinction must be drawn between the abvementioned devices and medical 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- to xicological and clinical standards and protocols in respect of the testing of proprietary medicinal products;
鑒于部分醫(yī)療器材是符合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(guān)之法律，法規(guī)或管理行為所訂之實施規(guī)定，鑒于醫(yī)療器材之上市基本上由本指令規(guī)范，但醫(yī)療產(chǎn)品之上市則受65/65/EEC號指令規(guī)范；鑒于若有某種器材須與其他醫(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(yīng)受65/65/EEC號指令規(guī)范；鑒于前述之醫(yī)療器材和包含醫(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)定之醫(yī)療器材應(yīng)加以區(qū)別；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(guān)分析藥物毒性和臨床之標(biāo)準(zhǔn)及調(diào)查書的法律調(diào)和]，醫(yī)療物質(zhì)之安全，品質(zhì)及效用在前述情況下則須依該指令明定之適當(dāng)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 interprepreted 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;
鑒于本指令附件所訂之基本要求及其他要求，包括[最低]或[降低]危險部分之應(yīng)用，應(yīng)考慮設(shè)計當(dāng)時之科技及實施情形，并在符合健康和安全高度保護的原則下考慮技術(shù)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(guān)技術(shù)調(diào)和與標(biāo)準(zhǔn)化新方針?biāo)喍ǖ脑瓌t，有關(guān)醫(yī)療器材之設(shè)計及執(zhí)照應(yīng)遵守相關(guān)條款以符合基本要求；鑒于這些要求屬基本要求，所以應(yīng)取代對應(yīng)之國家規(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;
鑒于基本要求之落實應(yīng)謹(jǐn)慎考慮設(shè)計當(dāng)時之科技術(shù)水準(zhǔn)，并在符合健康和安全高度保護的原則下考慮技術(shù)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(guān)主動植入式醫(yī)療器材法律調(diào)和]之理事指令是第一個應(yīng)用在醫(yī)療器材方面的新方法指令；鑒于為使共同體規(guī)定適用于所有的醫(yī)療器材，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之一般條款的部分；
Whereas the electromagnetic compatibility aspects form an integral part of the safety of medical devices; whereas the 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)療器材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(guān)電磁相容性法律調(diào)和]之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 Directive 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 directive on the same subject should continue to apply;
鑒于本指令應(yīng)包含釋放電離輻射醫(yī)療器材設(shè)計及制造的相關(guān)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(quán)，該指令目的在修訂為保護大眾工作人員健康，防止電離輻射危險而制訂基本安全標(biāo)準(zhǔn)之其他指令；本指令亦不影響1984年9月3日84/446/Euratom號[制訂保護人員在醫(yī)療檢查或治療中不受輻射影響之基本方法]理事會指令之適用；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之安全與健康]及其他相關(guān)主題之指令應(yīng)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)和之歐洲標(biāo)準(zhǔn)，以避免醫(yī)療器材在設(shè)計，制造及包裝上所可能帶來的危險，鑒于調(diào)和之歐洲標(biāo)準(zhǔn)由私人立法機構(gòu)制訂，而且應(yīng)維持自愿性質(zhì)；鑒于歐洲標(biāo)準(zhǔn)化委員會（CEN）及歐洲電標(biāo)準(zhǔn)化委員會（CENELEC）被認(rèn)為是制訂調(diào)和標(biāo)準(zhǔn)有能力的團體（competent bodies）,而此標(biāo)準(zhǔn)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(chǔ)的一般導(dǎo)原則；
Whereas, for the purpose of this Directive, a harmonized 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 83/139/EEC; whereas the measures to be taken must be defined in line with procedure l, 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 incorporate 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(dá)本指令目的，調(diào)和標(biāo)準(zhǔn)是前述機構(gòu)接獲理事會命令后，依理事會1983年3月28日通過之83/189/EEC號指令[有關(guān)制訂技術(shù)標(biāo)準(zhǔn)及法規(guī)資訊提供的程序]而采納的技術(shù)規(guī)范歐洲標(biāo)準(zhǔn)或調(diào)和文件，符合前述一般綱要的規(guī)定；鑒于調(diào)和標(biāo)準(zhǔn)的修正有賴于83/189/EEC號指令建立的委員會的協(xié)助；鑒于應(yīng)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(lǐng)域中現(xiàn)存之歐洲藥典專題論文應(yīng)納入本指令的架構(gòu)中；因此數(shù)篇歐洲藥典專題論文將視其與前述調(diào)和標(biāo)準(zhǔn)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 anables the responsibility of manufacturers and notifiled 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(guān)技術(shù)調(diào)和指令適用符合評鑒程序各階段模式]決定中制定調(diào)和的符合評鑒程序；鑒于這些模式于醫(yī)療器材之應(yīng)用，可以依相關(guān)器材之型式?jīng)Q定制造商及公告機構(gòu)在符合評鑒程序中應(yīng)負(fù)的責(zé)任；鑒于醫(yī)療器材的證明有必要在模式里增加細(xì)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 Ⅱ a 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(dá)到符合評鑒的目的有必要將醫(yī)療器材分類四類；鑒于分類是以考慮器材之技術(shù)設(shè)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)療器材對人體可能產(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(fù)責(zé)執(zhí)行；鑒于對第Ⅱ（a ）類醫(yī)療器材而言，在生產(chǎn)階段時公告機構(gòu)的介入應(yīng)屬強制性質(zhì)；鑒于屬于第Ⅱ（b）類及第Ⅲ類之醫(yī)療器材對人體具有較高的潛在危險，因此在器材的設(shè)計及制造階段必須有公告機構(gòu)的檢驗；鑒于第Ⅲ類的器材皆為較特別的器材，其一致性需在上市之前獲得明確授權(quán)；
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;
鑒于器材之一致性如能由制造商負(fù)責(zé)評鑒，相關(guān)主管機關(guān)，特別是緊急狀況時，應(yīng)能聯(lián)絡(luò)到一位設(shè)于共同體內(nèi)負(fù)責(zé)將器材在市場上銷售之人員，該人員可以是制造商本人或其他設(shè)于共同體內(nèi)經(jīng)制造商授權(quán)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)療器材應(yīng)附加CE標(biāo)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(shè)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(guān)共同體層次未來防止暨控制愛滋病相關(guān)活動的結(jié)論，用于防止HIV病毒感染的醫(yī)療器材應(yīng)提供人體高度的保護；此類產(chǎn)品的設(shè)計及制造應(yīng)由公告機構(gòu)的證實；
Whereas the classification rules generally enable medical devices to be 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(dāng)?shù)貙⑨t(yī)療器材分類；鑒于醫(yī)療器材性質(zhì)及相關(guān)領(lǐng)域技術(shù)進步之性質(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(quán)力及有關(guān)器材的分類或再分類，或者于適當(dāng)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(guān)聯(lián)，因此這些決議應(yīng)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(zé)任執(zhí)行臨床調(diào)查以證明其醫(yī)療器材符合安全要求；因此為保證大眾健康及秩序應(yīng)明訂執(zhí)行臨床調(diào)查的適當(dāng)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(guān)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(guān)各會員國水銀玻璃最高溫度計法律調(diào)和]之指令中所提及的醫(yī)療器材亦受本指令規(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日通過之84/539/EEC號指令[有關(guān)各會員國人類或動物醫(yī)療使用之電動醫(yī)療器材法律調(diào)和]，
HAS ADOPTED THIS DIRECTIVE：
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)療器材及其附屬物.附屬物在本指令的適用范圍內(nèi)亦視其為醫(yī)療器材.兩者以下皆稱器材.
2. For the purposes of this Directive, the following definitions shall apply;
為本指令之目地,下列定義適用于:
(a) medical device′means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of;
[醫(yī)療器材]是指制造商設(shè)計供人類于下列情況,不論是單獨或合并使用之儀器,設(shè)備,器材,材料或其他物品,包括適當(dāng)應(yīng)用所需的軟件,而此種應(yīng)用是廠商為人們下列之目地而訂定:
diagnosis, prevention, monitoring, treatment or alleviation of disease,
診斷,預(yù)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 modification of the anatomy or of a physiological process,
解剖或生理過程中之檢查,換置或修正,
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;
這些器材不可借藥性,免疫力或新陳代謝的方法在人體內(nèi)達(dá)到其主要設(shè)計的目的,但可用這些器材輔助其功能者;
(b) 'accessory' means an article which whilst not being a device is intended specifically by its manufacturer to be used 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;
[附屬物]是指本身不可獨立使用的器材,制造商設(shè)計附屬件之目地是配合其他器材合并使用,使該器材得以依其設(shè)計目地發(fā)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 there of;
[體外診斷用器材]是指任何自成單位或與其他物件組合之任何試劑,試劑品,套裝用具,儀器,設(shè)備或系統(tǒng)表態(tài)的器材.這種器材是制造商設(shè)計作為檢查人體組織標(biāo)本用的器材,以期能夠提供有關(guān)其生理狀況,健康或生病或任何先天不正常等訊息;
(d) 'custom-made device' means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient.
[訂制的器材]是指依照合格醫(yī)療從業(yè)人員描述的特色而特別制作的器材,該器材是為特定病患設(shè)計且專供該病患使用.
The above mentioned prescription may also be made out by any other person authorized by virtue of his professional qualifications to do so.
前述的描述可以由專業(yè)資格而獲授權(quán)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.
但訂制的器材不包括那些為滿足醫(yī)療人員或其他專汪使用人要求而改裝且大量生的器材.
(e) 'device intended for clinical investigation' means any device intended for use by a duly qualified medical practitioner when conducting investigations as referred to in Section 2.1 of Annex X in an adequate human clinical environment.
[臨床調(diào)查用之器材]是指由適當(dāng)?shù)暮细襻t(yī)療從醫(yī)人員在適當(dāng)?shù)念惻R床環(huán)境中,執(zhí)行附件十第2.1.所述之調(diào)查時所使用的任何器材.
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.
其他具專業(yè)資格的人員經(jīng)授權(quán)執(zhí)行此種臨床調(diào)查將視同合格醫(yī)療從事人員所執(zhí)行的臨床調(diào)查;
(f) 'manufacturel' means the natural or legal person with responsibility for the design, manufacture , packaging and labelling 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]是指器材以其名稱上市前,負(fù)責(zé)器材之設(shè)計,制造,包裝及貼附標(biāo)簽的自然人或法人,無論這些設(shè)計,制造等過程是否為自然人或法人親自執(zhí)行或委托第三者執(zhí)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 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;
本指令所規(guī)定有關(guān)制造商的責(zé)任亦適用于將一個或一個以上現(xiàn)成的產(chǎn)品加以組裝,包裝,加工,重新處理/或附加標(biāo)簽而成一器材,指定其用途并準(zhǔn)備以其名稱命名上市的自然人或法人.對于那些屬前一段制造商定義者,為個別病患的需要拼裝或改裝已上市銷售之器材的情形下適用本段的規(guī)定;
(g) 'intended purpose' means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials;
[預(yù)期的用途]是指器材須依照制造商于標(biāo)簽上,說明書及/或促銷宣稱中提供的使用條件及資料.
(h) 'placing on the market' means the first making available in return for payment or free of charge of a device other than 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]是指為大量行銷及/或于共同體市場使用之目的,首次以金錢交易或免費贈送方式提供臨床調(diào)查用全新或重新處理過之器材的行為;
(i) 'putting into service' means the stage at which a device is ready for use on the Community market for the first time for its intended purpose.
[開始使用]是指某一器材在共同體市場首次可依原訂之用途開始使用的日期.
3. Whereas a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 65/65/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.
對于用來管理65/65/EEC號指令第一條定義之醫(yī)療產(chǎn)品的器材,在不侵害65/65/EEC號有關(guān)醫(yī)療產(chǎn)品指令條款的規(guī)定下,該類器材應(yīng)受本指令規(guī)范.
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 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,假若某種器材須與其他醫(yī)療產(chǎn)品組合成一完整的產(chǎn)品而上市銷售使用,且無法二次使用時,該組合產(chǎn)品應(yīng)受65/65/EEC號指令規(guī)范.本指令附件一所列有關(guān)器材安全及性能方面的相關(guān)基本要求仍然適用.
4. Whereas a device incorporates, as an integral part, a substance which, if used separately, may be considered to be 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.
如果醫(yī)療器材包含某項醫(yī)療物質(zhì),而該物質(zhì)單獨使用時符合65/65/EEC號指令第一條對醫(yī)療產(chǎn)品的定義,且可能對人體產(chǎn)生作用以輔助醫(yī)療器材的作用時,該器材應(yīng)依照本指令的規(guī)定加以評鑒并授權(quán).
5. This Directive does not apply to.
本指令不適用于下列器材.
(a) in vitro diagnostic devices;
體外診斷器材;
(b) active implantable devices covered by Directive 90/385/EEC;
受90/385/EEC號指令規(guī)范之主動植入式醫(yī)療器材;
(c )medicinal products covered by Directive 65/65/EEC;
受65/65/EEC號指令規(guī)范之醫(yī)療產(chǎn)品
(d) medicinal products covered by Directive 76/768/EEC;
受76/768/EEC號指令規(guī)范之化妝品;
(e) human blood, human blood products, human plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells;
人類之血液,血液產(chǎn)品,血漿或血球,或者上市時包含人類血液產(chǎn)品,血漿或血球的器材;
(f) transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin;
人類之移植器官,組織或細(xì)胞及及包含或由人類組織,細(xì)胞產(chǎn)生的產(chǎn)品;
(g) transplants or tissues or cells of animal origin, unless device is manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissue;
動物之移植器官,組織或細(xì)胞;但利用死的動物組織或其產(chǎn)品而制造的器材則不在此限.
6. This Directive does not apply to personal protective equipment covered by Directive 89/686/EEC. In deciding whether 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號指令規(guī)范的個人保護裝備.而要決定某產(chǎn)品應(yīng)受該指令規(guī)范亦受本指令規(guī)范時,必須特別考慮該產(chǎn)品設(shè)計的主要目的.
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號指令第二條第2項中所述的特定指令.
8. This Directive does not affect the application of Directive 80/836/Euratom, not of Directive 84/466/Euratom.
本指令不影響80/836/Euratom指令及84/466/Euratom指令的實施.
Article 2
第2條
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.
各會員國必須采取所有必要的措施,以確保器材依其設(shè)計的目的安裝,維護及使用時不會犧牲病患,使用者或,適用時,其他人員的安全及健康后方可上市.
Article 3
第3條
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.
器材依其設(shè)計的目的必須符合附件一所列適用的基本要求,并顧及器材原先預(yù)期的用途.
Article 4
第4條
Free movement, devices intended for special purposes
自由流通及特殊目的器材
1. Member States shall not create any obstacle to the placing on the market or the putting into service within their territory 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.
各會員國在其領(lǐng)土內(nèi)不得對附加第十七條所述CE標(biāo)示器材之上市及使用設(shè)立任何障礙,CE標(biāo)示代表該器材已依第十一條的規(guī)定經(jīng)過符合評鑒的程序.
2. Member States shall not create any obstacle to :
對于下列器材會員國不得設(shè)有任何障礙.
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,
符合第十五條及附件八規(guī)定,供醫(yī)療從業(yè)人員或經(jīng)授權(quán)之人員執(zhí)行臨床調(diào)查而制造的器材
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.
符合第十一條及附件八規(guī)定上市及使用的訂制器材;屬于第Ⅱa, Ⅱb,及Ⅲ類器材須附有附件八所提之說明資料.
These devices shall not bear the CE marking.
上述器材無需附加CE標(biāo)志.
3. At trade fairs, exhibitions, demonstrations, etc. Member States shall not create any obstacle to the showing of devices 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.
對于未符合本指令之器材,但有明顯的標(biāo)識說明該器材在未符合本指令之規(guī)定前不可上市銷售或使用時,各會員國不得妨礙其于商展中展示.
4. Member States may require the information, which must be made available to the user and the patient in accordance with Annex 1, 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.
會員國得要求專業(yè)或非專業(yè)用途之醫(yī)療器材,其依附件一第13點規(guī)定使用者及病患使用的相關(guān)資訊必須以該國語言或其他共同體語言書寫.
5. Where the devices are subject to other Directives concerning other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that the devices also fulfil the provisions of the other Directives.
若某器材在其他方面亦受到其他指令的規(guī)范,且該等指令同時包含CE標(biāo)示附加之說明,則其CE標(biāo)示表示該器材亦符合其他指令的條款.
However, should one or more of these directives allow the manufacturer, during a transitional period, to shoose 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.
但是,如果上述指令中有單一或多數(shù)指令允許制造商在一段過渡期間內(nèi)選擇適用的安排,則CE標(biāo)示只表示符合制造商所選擇適用的指令.在此種情況下,上述指令于歐體公報中所公布的細(xì)則應(yīng)于指令要求的文件,通告或說明中列出,并附隨器材.
Article 5
第5條
Reference to standards
標(biāo)準(zhǔn)之參考
1. Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonized standards the references of which have been publishes in the Official Journal of the European Communities; Member States shall publish the references of such national standards.
對于符合相關(guān)國家標(biāo)準(zhǔn)的器材,會員國應(yīng)假定其符合第三條所述之基本要求,該相關(guān)國家標(biāo)準(zhǔn)必須是依照調(diào)標(biāo)準(zhǔn)(其參考號碼刊登于歐體公報中)更多
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