COUNCIL DIRECTIVE 93/42/EEC
Of 14 June 1993
1993年 6 月 14 日理(li)事會第(di) 93/42/EEC 號(hao)指令
concerning medical devices
關于醫療器材
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,
依據歐洲經濟體所制訂的羅馬條約，特別是第 100 條規定
Hving regard to the prposal from the Commission
依據執委會的建議案
In cooperation with the European Parliament
配合歐洲議會
Having regard to ;the opinion of the Economic and Social Committee.
依(yi)據經(jing)濟暨社會(hui)委員會(hui)的(de)意(yi)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(yu)內部(bu)市場之完(wan)成應采取一些措施；鑒于(yu)內部(bu)市場是(shi)一無內部(bu)疆界之區域，區域內之貨品(pin)，人(ren)員(yuan)，服務及資金應可自(zi)由流(liu)通(tong)
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(ge)會員國間現存有關醫療器材安全，對(dui)健康之(zhi)(zhi)保護及使用特性(xing)方(fang)面之(zhi)(zhi)法律，法規及行政命令之(zhi)(zhi)內(nei)容與(yu)范圍不盡相同(tong)(tong)；鑒于各(ge)會員國對(dui)此器材之(zhi)(zhi)驗證及檢驗程序(xu)也不相同(tong)(tong)；鑒于前述之(zhi)(zhi)分(fen)歧將阻礙(ai)共(gong)同(tong)(tong)體(ti)內(nei)的貿易活動；
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(yu)醫(yi)療器(qi)械(xie)之使(shi)(shi)用對(dui)病患，使(shi)(shi)用者(zhe)，甚至其他人有關安(an)全及健(jian)康保(bao)(bao)護的相關國(guo)家規(gui)定應加以調(diao)和(he)，以保(bao)(bao)證此(ci)類器(qi)材在(zai)內(nei)部市場自由流通(tong)；
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;
鑒于調和(he)之(zhi)規(gui)定必然與(yu)各會(hui)員國(guo)(guo)采取之(zhi)部分措(cuo)施(shi)有所不(bu)(bu)同，這(zhe)些(xie)措(cuo)施(shi)是(shi)為籌(chou)措(cuo)公共健康與(yu)疾病保險計劃之(zhi)基金，且直(zhi)接(jie)或間接(jie)與(yu)醫療器材有關(guan)；鑒于共同體若與(yu)上述(shu)措(cuo)施(shi)相(xiang)符，則這(zhe)些(xie)規(gui)定并不(bu)(bu)影響會(hui)員國(guo)(guo)落(luo)實(shi)上述(shu)措(cuo)施(shi)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;
鑒于醫療器材應提供病患，使(shi)用(yong)者(zhe)及第三者(zhe)高度(du)之保護，且應該達到廠商(shang)所要(yao)求之性(xing)能水準；鑒于維持(chi)或改進各會員(yuan)國對病患等保護的程度(du)乃本(ben)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;
鑒于部分醫療器材是符合1965年1月(yue)26日理(li)事會第65/65/EEC號指(zhi)令(ling)，與(yu)專賣(mai)醫(yi)藥產品(pin)有關之法律，法規(gui)(gui)或(huo)管理行為所訂之實施(shi)規(gui)(gui)定，鑒于醫(yi)療(liao)器材(cai)之上市基本(ben)上由(you)本(ben)指(zhi)令(ling)規(gui)(gui)范(fan)，但(dan)醫(yi)療(liao)產品(pin)之上市則受65/65/EEC號指令規范；鑒于若有某種器(qi)材須與其他(ta)醫(yi)療(liao)產品(pin)組(zu)成一完整的(de)產品(pin)而上市銷售，使用(yong)，且無法二次使用(yong)時，則該組(zu)合產品(pin)應(ying)受65/65/EEC號指令規(gui)范；鑒(jian)于(yu)前述之醫療器(qi)材和包(bao)含(han)醫療物(wu)(wu)質且(qie)該物(wu)(wu)質單獨使用時符合65/65/EEC號指令規定之醫療器材應(ying)加(jia)以區別；鑒于1975年(nian)5月20日75/318/EEC號理事會指(zhi)令[制(zhi)定(ding)各會(hui)員國(guo)在測試專利醫療產品方(fang)面有關分析藥物毒性和(he)臨床(chuang)之標準及調查書(shu)的法律調和(he)]，醫療(liao)物質之(zhi)(zhi)安(an)全(quan)，品質及效用在前(qian)述情況下則(ze)須依該(gai)指令明定(ding)之(zhi)(zhi)適當方(fang)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(di)]或[降低]危險部(bu)分之應用，應考慮(lv)(lv)設計(ji)當(dang)時之科技及(ji)實施情形，并在(zai)符合(he)健(jian)康和安全(quan)高度保(bao)護的(de)原則(ze)下考慮(lv)(lv)技術及(ji)經濟的(de)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和與標準化新方針所訂定的原則(ze)，有關醫療器材之設計及執照(zhao)應(ying)遵守(shou)相關條款以符合基本要(yao)求(qiu)(qiu)；鑒于這些要(yao)求(qiu)(qiu)屬基本要(yao)求(qiu)(qiu)，所以應(ying)取代對應(ying)之國家規定；
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(yu)基本要求之落實應(ying)謹(jin)慎考慮設計當(dang)時之科(ke)技術(shu)水準，并(bing)在符合(he)健康和(he)安全高(gao)度(du)保護的原則下考慮技術(shu)及經(jing)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(de)90/385/EEC號[各(ge)會(hui)員(yuan)國有(you)關(guan)主動植(zhi)入式醫療器材法律調和]之(zhi)理事指令是第(di)一個應用(yong)在醫療(liao)器(qi)(qi)材方(fang)面的新(xin)方(fang)法(fa)指令；鑒(jian)于(yu)(yu)為使共同體(ti)規定適用(yong)于(yu)(yu)所有(you)的醫療(liao)器(qi)(qi)材，本指令基本上是以90/385/EEC號指令的條(tiao)款(kuan)為(wei)依據；鑒于90/385/EEC號指(zhi)令，因此(ci)也必須增(zeng)加本(ben)指(zhi)令所列之(zhi)一般條款(kuan)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;
鑒于醫療器材的電磁相容性是整個產品安全的一部分；鑒于本指令因此須包括1989年5月3日89/336/EEC號(hao)[各會員(yuan)國有關電磁相容性法律調和]之(zhi)理事(shi)會(hui)指(zhi)令(ling)中所制訂的特定規定；
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;
鑒于本指令應包含釋放電離輻射醫療器材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(ling)所需要的授權，該(gai)指令(ling)目的在修訂(ding)為保護大眾(zhong)工作(zuo)人員健(jian)康(kang)，防止電離輻射(she)危險而制訂(ding)基本安全標(biao)準之(zhi)其他指令(ling)；本指令(ling)亦不(bu)影(ying)響1984年9月3日84/446/Euratom號[制訂保護人員在醫(yi)療(liao)檢查或治療(liao)中不受(shou)輻射(she)影響之基本方(fang)法]理(li)事會(hui)指令之適用(yong)；鑒于1989年6月12日89/391/EEC號(hao)理事(shi)會指令(ling)[鼓(gu)勵改善工作場所中工人之安全與健康]及其他(ta)相關(guan)主題之指(zhi)令(ling)應(ying)持續適用(yong)；
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，有必要建立調和之歐洲標準，以避免醫療器材在設計，制造及包裝上所可能帶來的危險，鑒于調和之歐洲標準由私人立法機構制訂，而且應維持自愿性質；鑒于歐洲標準化委員會（CEN）及(ji)歐洲(zhou)電標準化委員會（CENELEC）被認為是制(zhi)訂調和標準有(you)能力的團體(ti)（competent bodies）,而此(ci)標(biao)準符合1984年11月13日執(zhi)委會與上述兩團體所簽訂的(de)合作(zuo)綱要為基礎的(de)一般導原(yuan)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;
鑒于為達本指令目的，調和標準是前述機構接獲理事會命令后，依理事會1983年3月(yue)28日通過之83/189/EEC號指令(ling)[有關制(zhi)訂技術標準及法規資(zi)訊提供的程序]而采(cai)納的技術(shu)規范歐洲標(biao)準或調(diao)和文件(jian)，符合前述一般綱要(yao)的規定(ding)；鑒(jian)于(yu)調(diao)和標(biao)準的修正有(you)賴(lai)于(yu)83/189/EEC號指令(ling)建立(li)的委員(yuan)會的協助；鑒(jian)于(yu)應采取的措(cuo)施須(xu)依照理(li)事會87/378/EEC號指令(ling)程序一的(de)規定；鑒(jian)于特殊(shu)領域中現存(cun)之歐(ou)洲藥典專題論(lun)文(wen)應納入本(ben)指令(ling)的(de)架構中；因此數篇歐(ou)洲藥典專題論(lun)文(wen)將視其與前述調和標(biao)準有著同等(deng)的(de)效(xiao)力(li)；
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(yue)13日(ri)通(tong)過的90/683/EEC號[有(you)關技(ji)術調和指(zhi)令適用符合評(ping)鑒程序各階段模式(shi)]決定(ding)中制(zhi)定(ding)調(diao)和的(de)符合評(ping)鑒(jian)程序(xu)；鑒(jian)于這些模(mo)式于醫療(liao)器(qi)(qi)材(cai)之應(ying)用，可以依(yi)相關器(qi)(qi)材(cai)之型式決定(ding)制(zhi)造(zao)商及公告機構在符合評(ping)鑒(jian)程序(xu)中應(ying)負的(de)責任；鑒(jian)于醫療(liao)器(qi)(qi)材(cai)的(de)證明有必要在模(mo)式里增加細節(jie)的(de)規定(ding)；
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;
鑒于為達到符合評鑒的目的有必要將醫療器材分類四類；鑒于分類是以考慮器材之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類醫療器材對人體可能產生的傷害較輕微，其符合性評鑒程序大致可由制造商完全負責執行；鑒于對第Ⅱ（a ）類醫療器材而言，在生產階段時公告機構的介入應屬強制性質；鑒于屬于第Ⅱ（b）類(lei)及第Ⅲ類(lei)之醫療器(qi)材(cai)對(dui)人(ren)體(ti)具有較高的潛在危險，因此在器(qi)材(cai)的設計及制造階(jie)段必須有公告機構的檢驗；鑒于第Ⅲ類(lei)的器(qi)材(cai)皆為較特別的器(qi)材(cai)，其一致性需在上(shang)市之前獲得明確授權(quan)；
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(yu)(yu)器(qi)材之(zhi)一(yi)致性如(ru)能由制(zhi)(zhi)造商負責(ze)評鑒，相關主管(guan)機關，特別是緊急狀(zhuang)況時，應能聯絡到一(yi)位設于(yu)(yu)共同(tong)體(ti)內(nei)負責(ze)將器(qi)材在市場上銷(xiao)售之(zhi)人(ren)員(yuan)，該人(ren)員(yuan)可(ke)以是制(zhi)(zhi)造商本人(ren)或其(qi)他設于(yu)(yu)共同(tong)體(ti)內(nei)經(jing)制(zhi)(zhi)造商授權(quan)的人(ren)員(yuan)；
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;
鑒于醫療器材應附加CE標(biao)志，表示其符合(he)本(ben)指令的條款，而得以在共(gong)同體(ti)市場(chang)上自由流(liu)通(tong)并依(yi)其設計的目的使(shi)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(you)關(guan)共同體(ti)層次(ci)未來防止(zhi)暨控(kong)制愛(ai)滋病相(xiang)關(guan)活動(dong)的結論，用(yong)于防止(zhi)HIV病毒(du)感染(ran)的醫療器(qi)材應(ying)提供人(ren)體(ti)高(gao)度的保護；此類產品的設(she)計及(ji)制造應(ying)由公(gong)告(gao)機構的證實；
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地將醫療器材分類；鑒于醫療器材性質及相關領域技術進步之性質各異，因此必須采取一些措施以決定授予執委會的執行權力及有關器材的分類或再分類，或者于適當時調整分類的原則；鑒于上述的問題與人員健康的保護有著密切的關聯，因此這些決議應依照87/373/EEC號指令程序Ⅲa規定；
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(yu)制造商有責任(ren)執行(xing)臨床調查以(yi)證(zheng)明其醫(yi)療器材符合安全要求；因(yin)此(ci)為保證(zheng)大眾健(jian)康(kang)及秩序應明訂執行(xing)臨床調查的適當(dang)方(fang)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(yu)健(jian)康的(de)保(bao)護(hu)及相關的(de)管制方法以在共同體層次上建(jian)立一個醫(yi)療裝置(zhi)警戒系統為最有效；
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(ri)通過76/764/EEC號(hao)[有關各會員國水銀玻璃最高溫(wen)度計(ji)法律調和(he)]之指令中所提及的醫療器材亦受本指令規范；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(ri)通過之(zhi)84/539/EEC號指令(ling)[有(you)關各(ge)會員(yuan)國(guo)人類或動物醫療使用之電動醫療器(qi)材法律調和]，
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.
本指令適用于醫療器材及其附屬物.附屬物在本指令(ling)的適(shi)用范圍內亦視其為醫療器材.兩者以下皆稱(cheng)器材.
2. For the purposes of this Directive, the following definitions shall apply;
為本指令之目地,下列定(ding)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;
[醫療器(qi)材]是指制(zhi)造商(shang)設計供(gong)人類于下列情況(kuang),不論(lun)是單獨或合(he)并使用之(zhi)儀器,設備,器材,材料或其他(ta)物品,包括適(shi)當(dang)應(ying)用(yong)所需的軟件(jian),而此種應(ying)用是廠商為人(ren)們下列之目地而訂定:
diagnosis, prevention, monitoring, treatment or alleviation of disease,
診斷,預防,追蹤,治(zhi)療或減輕疾(ji)病,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
診斷,追蹤,治療或(huo)修(xiu)整傷處或(huo)殘障部(bu)位(wei),
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(huo)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(li)或新陳代謝的(de)方(fang)法在人體內達到其主(zhu)要設計的(de)目的(de),但可用這些(xie)器材(cai)輔助其功能者(zhe);
(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(ben)身(shen)不可獨(du)立使用的器材,制(zhi)造商設計附屬(shu)件之目(mu)地是配(pei)合其(qi)他器材(cai)合并使用,使該器材得以依(yi)其設計目地(di)發生功用(yong);
(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(cai)]是指任何(he)(he)自成(cheng)單(dan)位或(huo)與(yu)其他物件組合之(zhi)任何(he)(he)試(shi)劑,試劑品,套裝用具,儀器,設備(bei)或系統表態的(de)器材(cai).這種器材是(shi)制造商設計(ji)作為(wei)檢查人體(ti)組織標本(ben)用(yong)的器材,以(yi)期能夠(gou)提供有關(guan)其生理(li)狀況,健康(kang)或(huo)生病或(huo)任何先天(tian)不(bu)正常(chang)等訊(xun)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(zhi)的器材]是指(zhi)依照(zhao)合格醫(yi)療從業(ye)人員(yuan)描述的特(te)(te)色而特(te)(te)別(bie)制作的器材,該(gai)器材是為特定病患設(she)計且專供該(gai)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(de)描述可以(yi)由專業資(zi)格而(er)獲授權的(de)其(qi)他(ta)人提供(gong).
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(ding)制的器材(cai)(cai)不包括那(nei)些為滿足醫療(liao)人員或其(qi)他專汪使用人要求而改裝且大量生的器材(cai)(cai).
(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.
[臨床調查用(yong)之器材(cai)]是指(zhi)由適當的合格醫(yi)療從(cong)醫(yi)人員(yuan)在適當的類臨床環(huan)境中(zhong),執行附件十第2.1.所(suo)述(shu)之調查(cha)時所(suo)使(shi)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(ju)專業資格的人(ren)員經授權執(zhi)行(xing)此種臨(lin)床(chuang)調查(cha)將視同(tong)合格醫療從事人(ren)員所執(zhi)行(xing)的臨(lin)床(chuang)調查(cha);
(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(cai)以其(qi)名稱上市(shi)前,負責器材之設(she)計,制造,包裝及貼附標簽的自然人(ren)(ren)或(huo)法人(ren)(ren),無論(lun)這些(xie)設計(ji),制造等(deng)過(guo)程是(shi)否為自(zi)然(ran)人或法(fa)人親(qin)自(zi)執行(xing)或委托第三者(zhe)執行(xing).
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;
本指令所規定有關制造商的責任亦適用于將一個或一個以上現成的產品加以組裝,包裝,加工,重(zhong)新處理/或附加標簽而成(cheng)一(yi)器(qi)材(cai),指(zhi)定其用途并準(zhun)備以其名稱命名上市的自然人(ren)或法人(ren).對(dui)于(yu)那些屬前一段制(zhi)造商定義者,為個別病患的(de)需要拼裝(zhuang)或改裝(zhuang)已上市(shi)銷售之器材的(de)情形下適用本段的(de)規定;
(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;
[預期的(de)用(yong)途]是指器材須依照制造(zao)商于標簽(qian)上,說明書及(ji)/或(huo)促(cu)銷宣稱(cheng)中提(ti)供的使用條件及資(zi)料(liao).
(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(shang)市]是指為大(da)量行銷及/或于共同體市場(chang)使用之目的,首次以金錢交易或免(mian)費(fei)贈送方式提(ti)供(gong)臨床調(diao)查(cha)用全新(xin)或重新(xin)處理過(guo)之器材的行為(wei);
(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(shi)場(chang)首(shou)次可依(yi)原訂之(zhi)用途開始使用的日(ri)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(ding)義(yi)之醫療產(chan)品(pin)的器(qi)材,在(zai)不(bu)侵害65/65/EEC號有關醫(yi)療產(chan)品(pin)指令(ling)條款的規定下(xia),該類器材應受本指(zhi)令規(gui)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療產品組合(he)成一完整的(de)產品而上市銷售使用,且無法二(er)次使(shi)用時(shi),該組合產品應受65/65/EEC號(hao)指令規(gui)范.本指(zhi)令附(fu)件一所列有關器材安(an)全及性能方(fang)面(mian)的相關基本要求仍(reng)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.
如果醫療器材包含某項醫療物質,而(er)該物(wu)質單(dan)獨使(shi)用時符合65/65/EEC號指令第一條對醫(yi)療(liao)產品(pin)的(de)定義(yi),且(qie)可(ke)能對人體產生作(zuo)用以輔(fu)助醫(yi)療(liao)器材的(de)作(zuo)用時,該器材應(ying)依照本指令的規定加以評鑒并授權(quan).
5. This ;Directive does not apply to.
本(ben)指令不適用于下列(lie)器材(cai).
(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號指令規范(fan)之(zhi)主動(dong)植入(ru)式醫療器材;
(c )medicinal products covered by Directive 65/65/EEC;
受65/65/EEC號指令規范(fan)之(zhi)醫療產品
(d) medicinal products covered by Directive 76/768/EEC;
受76/768/EEC號指令規(gui)范之(zhi)化(hua)妝(zhuang)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,血液產品,血(xue)漿(jiang)或血(xue)球(qiu),或者(zhe)上市(shi)時包含人類(lei)血液產品,血漿(jiang)或血球(qiu)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,組織或細胞(bao)及(ji)及(ji)包(bao)含或由人(ren)類組織,細胞產(chan)生的(de)產(chan)品(pin);
(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(zu)織或細胞;但利用死的(de)動物(wu)組(zu)織或其產(chan)品而制造的(de)器材(cai)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號指令規范(fan)的個人(ren)保(bao)護裝備.而(er)要決定某產(chan)品應(ying)受(shou)該(gai)指令規(gui)范(fan)(fan)亦受(shou)本指令規(gui)范(fan)(fan)時,必須特別考慮該產品設(she)計的(de)主要目的(de).
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(di)二條第(di)2項(xiang)中所述(shu)的特定指(zhi)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(shi).
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(qi)材依其設計的目的安裝,維護及使用(yong)時不會犧牲(sheng)病患,使用者或,適用時,其他人員(yuan)的安全及健(jian)康后(hou)方可上(shang)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(yu)期(qi)的(de)用途.
Article 4
第4條
Free movement, devices intended for special purposes
自(zi)由流通(tong)及(ji)特殊(shu)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.
各會員國在其領土內不得對附加第十七條所述CE標(biao)示器材之上市及使用設立任何(he)障礙,CE標示代表(biao)該器材(cai)已依第十一條的規定經(jing)過符合(he)評鑒的程序.
2. Member States shall not create any obstacle to :
對(dui)于下列器(qi)材會(hui)員國不得設有任何障礙.
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定,供(gong)醫療(liao)從業人員或經(jing)授權之人員執行臨床調查(cha)而制造的器(qi)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定上市及使用的訂制器材;屬于第Ⅱa, Ⅱb,及Ⅲ類(lei)器材須附(fu)有附(fu)件八所提(ti)之(zhi)說明資料(liao).
These devices shall not bear the CE marking.
上述器材無需附加CE標志.
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(ming)顯的標識(shi)說明(ming)該器材在未符合本(ben)指令(ling)之規(gui)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.
會員國得要求專業或非專業用途之醫療器材,其依附(fu)件一第13點規定(ding)使用者及病患使用的(de)相(xiang)關資訊必須(xu)以(yi)該國(guo)語言或(huo)其他共(gong)同(tong)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范,且該等指令同時包(bao)含CE標(biao)示附加之說明(ming),則其CE標示表示該器(qi)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(ru)果上述(shu)指令(ling)中有單一或多數指令(ling)允許制造商在一段過渡期間內選擇適用的(de)安排,則CE標示只表示符合(he)制(zhi)造(zao)商(shang)所選擇適用(yong)的指令.在此(ci)種情況下,上(shang)述指令(ling)于歐體(ti)(ti)公(gong)報(bao)中所(suo)公(gong)布的(de)細則(ze)應于指令(ling)要求的(de)文件,通告或說(shuo)明中列(lie)出,并(bing)附隨器材.
Article 5
第5條
Reference to standards
標準之參考
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.
對于符合相關國家標準的器材,會員國應假定(ding)其符合(he)第三(san)條所述之基本要求(qiu),該相(xiang)關國家標準(zhun)必須是依照調標準(zhun)(其參(can)考(kao)號(hao)碼刊登(deng)于歐體公報中)更多
-
服務流程資料添加中....
- 官方收費資料添加中....
- 基礎法規資料添加中....
- 相關服務資料添加中....
全國服務熱線：
