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欧盟CE认证

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DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998 on in vitro diagnostic medical devices

体外诊断医疗设备指令

、范围

This Directive shall apply to in vitro diagnostic medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as in vitro diagnostic medical devices in their own right. Both in vitro diagnostic medical devices and accessories shall hereinafter be termed devices.

本指令适用于体外诊断医疗设备及其附件。为本指令的目的,附件本身应被视为体外诊断医疗设备。体外诊断医疗设备和附件以下均应称为设备

二、IVDD指令关键名词解释:

For the purposes of this Directive, the following definitions shall apply:

‘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:

“医疗装置”是指制造商拟供人类用于以下目的的任何仪器、器具、器具、材料或其他物品,无论单独使用或组合使用,包括为其适当应用所必需的软件:

— diagnosis, prevention, monitoring, treatment or alleviation of disease,

诊断、预防、监测、治疗或减轻疾病,

— diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap, 对受伤或残疾的诊断、监测、治疗、减轻或补偿,

— investigation, replacement or modification of the anatomy or of a physiological process, 解剖或生理过程的研究、替换或修改,

— control of conception, 控制概念

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;

不能通过药理学、免疫学或代谢手段在人体内或人体上实现其主要预期作用,但可以通过这些手段辅助其功能;

(b) ‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, 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 for the purpose of providing information: “体外诊断医疗设备”是指任何医疗设备是一种试剂,试剂产品,校准器,控制材料,设备,工具,仪器,设备,或系统,无论单独使用或组合,由制造商预期使用的体外检测的标本,包括血液和组织捐赠,源自人类的身体,完全或主要是为了提供信息:

— concerning a physiological or pathological state, or关于生理或病理状态的,或

— concerning a congenital abnormality, or关于先天畸形的,或

— to determine the safety and compatibility with potential recipients, or以确定与潜在接收者的安全性和兼容性,或

— to monitor therapeutic measures. 监测治疗措施

Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. 标本容器被认为是体外诊断医疗设备。“标本容器”是指制造商专门为体外诊断检查目的而对取自人体的标本进行主要容器和保存的设备,无论是否是真空型的。

Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination; 一般实验室使用的产品不是体外诊断医疗设备,除非这些产品的制造商根据其特性专门用于体外诊断检查;

 

(g) ‘authorised representative’ means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this Directive; “授权代表”是指在共同体中设立的任何自然人或法人,由制造商明确指定,就制造商在本指令下的义务采取行动,并可由共同体的当局和机构代替制造商处理;

 

三、合格评定程序Conformity assessment procedures(认证程序)

1. For all devices other than those covered by Annex II and devices for performance evaluation, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex III and draw up the EC declaration of conformity required before placing the devices on the market. 除附件II所涵盖的装置及性能评估装置外的所有装置,制造商须按照附件III所述程序,在该等装置投放市场前,拟备符合欧盟要求的声明,以贴有CE标志。

For all devices for self-testing other than those covered by Annex II and devices for performance evaluation, the manufacturer shall, prior to the drawing up of the aforementioned declaration of conformity, fulfil the supplementary requirements set out in Annex III, point 6. 除附件二所列的自检装置和性能评估装置外,制造商须在拟定上述合格声明前,满足附件三第6点所列的补充要求。

Instead of applying this procedure, the manufacturer may follow the procedure referred to in paragraphs 2 or 3. 制造商可采用第2或第3段所述的程序,而不是采用此程序。

2. For all devices referred to in List A in Annex II other than those intended for performance evaluation, the manufacturer shall, in order to affix the CE marking either:

对于附件二清单A中提及的所有设备,除了用于性能评估的设备外,制造商为了贴有CE标志,应:

(a) follow the procedure relating to the EC declaration of conformity set out in Annex IV (full quality assurance), or按照附件IV(全面品质保证)所载有关欧洲委员会合格声明的程序,或

(b) follow the procedure relating to EC type-examination set out in Annex V coupled with the procedure relating to the EC declaration of conformity set out in Annex VII (production quality assurance). 遵守附件五所载有关欧盟产品类型检验的程序,以及附件七所载有关欧盟产品合格声明的程序(产品质量保证)。

3. For all devices referred to in List B in Annex II other than those intended for performance evaluation, the manufacturer shall for the purposes of affixing the CE marking, follow either: 对于附件二清单B中提及的所有设备,除了用于性能评估的设备外,制造商在贴上CE标记时,应遵循以下规定:

(a) the procedure relating to the EC declaration of conformity set out in Annex IV (full quality assurance) or附件IV(全面品质保证)所载有关欧盟委员会合格声明的程序或

(b) the procedure relating to EC type-examination set out in Annex V couplet with: 附件五所载有关欧盟委员会类型检验的程序:

(i) the procedure relating to EC verification set out in Annex VI, or有EC verification的程序载于附件六,或

(ii) the procedure relating to the EC declaration of conformity set out in Annex VII (production quality assurance). 有关欧盟合格声明的程序载于附件七(生产品质保证)。

4. In the case of devices for performance evaluation, the manufacturer shall follow the procedure referred to in Annex VIII and draw up the statement set out in that Annex before such devices are made available. This provision does not affect national regulations relating to the ethical aspects of carrying out performance evaluation studies using tissues or substances of human origin.

对于性能评估的设备,制造商应遵循附件八中所述的程序,并在设备提供之前拟定附件中所述的说明。这项规定不影响有关利用人类来源的组织或物质进行业绩评价研究的伦理方面的国家条例。

5. During the conformity assessment procedure for a device, the manufacturer and, if involved, the notified body shall take account of the results of any assessment and verification operations which, where appropriate, have been carried out in accordance with this Directive at an intermediate state of manufacture.

在设备的符合性评估过程中,制造商和公告机构(如果涉及)应考虑任何评估和验证操作的结果,在适当的情况下,这些操作已按照本指令在中间生产状态下进行。

6. The manufacturer may instruct his authorized representative to initiate the procedures provided for in Annexes III, V, VI and VIII.

制造商可指示其授权代表启动附件III、V、VI和VIII中规定的程序。

7. The manufacturer must keep the declaration of conformity, the technical documentation referred to in Annexes III to VIII, as well as the decisions, reports and certificates, established by notified bodies, and make it available to the national authorities for inspection purposes for a period ending five years after the last product has been manufactured. Where the manufacturer is not established in the Community, the obligation to make the aforementioned documentation available on request applies to his authorised representative.

制造商必须符合标准声明,技术文档在附件三到八,以及决定,报告和证书,由NB机构,并使其可用国家当局用于检验一段结束后五年过去产品生产。如果制造商不是在欧共体建立的,应要求提供上述文件的义务适用于其授权代表。

8. Where the conformity assessment procedure involves intervention of a notified body, the manufacturer, or authorised representative, may apply to a body of his choice within the framework of tasks for which the body has been notified. 如果符合性评估程序涉及公告机构的干预,制造商或授权代表可以在已通知该机构的任务框架内,向其选择的机构申请。

9. The notified body may require, where duly justified, any information or data, which is necessary for establishing and maintaining the attestation of conformity in view of the chosen procedure. NB机构可以要求,在适当的情况下,任何信息或数据,这是建立和维持符合所选择的程序认证所必需的。

10. Decisions taken by the notified bodies in accordance with Annexes III, IV, and V shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both parties, for further periods of up to five years. 公告机构根据附件三、四、五作出的决定有效期最长为五年,可以在双方签署的合同中约定的时间申请延长,最长为五年。

11. The records and correspondence relating to the procedures referred to in paragraphs 1 to 4 shall be in an official language of the Member State in which the procedures are carried out and/or in another Community language acceptable to the notified body. 与第1至第4款所述程序有关的记录和通信应以执行该程序的成员国的官方语言和/或以公告机构可接受的其他共同体语言。

12. By way of derogation from paragraphs 1 to 4, the competent authorities may authorise, on duly justified request, the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices for which the procedures referred to in paragraphs 1 to 4 have not been carried out and the use of which is in the interest of protection of health. 减损从段落1到4,主管机关授权,在适时合理的要求,市场上的放置和投入服务,有关成员国境内的,内提及的个人设备的程序段1到4尚未进行,使用的是健康的保护。

13. The provisions of this Article shall apply accordingly to any natural or legal person who manufacturers devices covered by this Directive and, without placing them on the market, puts them into service and uses them in the context of his professional activity. :本条款的规定将相应地适用于任何制造本指令所涵盖的设备,并且在没有将其投放市场的情况下,将其投入服务并在其专业活动中使用的自然人或法人。

 

四、欧盟医疗注册

Article 10 Registration of manufacturers and devices制造商和设备的注册

1. Any manufacturer who places devices on the market under his own name shall notify the competent authorities of the Member State in which he has his registered place of business: 任何以自己的名义在市场上投放设备的制造商应通知其注册营业地所在成员国的主管当局:

— of the address of the registered place of business, 注册营业地点的地址,

— of information relating to the reagents, reagent products and calibration and control materials in terms of common technological characteristics and/or analytes and of any significant change thereto including discontinuation of placing on the market; for other devices, the appropriate indications, 有关试剂、试剂产品和校准和控制材料的共同技术特性和/或分析物的信息,以及任何重大改变,包括停止上市的信息;对于其他设备,适当的适应症,

— in the case of devices covered by Annex II and of devices for self-testing, of all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Annex I, part A, section 3, the outcome of performance evaluation pursuant to Annex VIII, certificates and any significant change thereto, including discontinuation of placing on the market. 在设备的情况下由附件II和自我测试的设备, 所有的数据允许这类设备的识别、分析,在适当情况下,诊断参数如附件I part A部分, 第3节,绩效评估的结果根据附件VIII, 证书和任何重大改变,包括市场上放置的中止

2. For devices covered by Annex II and for devices for self-testing, Member States may request to be informed of the data allowing identification together with the label and the instructions for use when such devices are placed on the market and/or put into service within their

territory. 对于附件二所涵盖的设备和用于自我测试的设备,当这些设备在其

区域内投放市场和/或投入使用时,成员国可要求获得允许识别的数据以及标签和使用说明。

These measures cannot constitute a precondition for the placing on the market and/or putting into service of devices which are in conformity with this Directive. 这些措施不能构成符合本指令的装置上市和/或投入使用的先决条件。

3. Where a manufacturer who places devices on the market under his own name does not have a registered place of business in a Member State, he shall designate an authorised representative. The authorised representative shall notify the competent authorities of the Member State in which he has his registered place of business of all particulars as referred to in paragraph 1.

如果以自己的名义在市场上投放设备的制造商在成员国没有注册营业地,他必须指定一名授权代表。授权代表应将第1款所述的一切详情通知其注册营业地所在成员国的主管当局。

4. The notification referred to in paragraph 1 shall also include any new device. In addition, where, in the context of such notification, a device notified, bearing the CE marking, is a ‘new product’, the manufacturer shall indicate this fact on his notification. :第一项之通知,亦应包括任何新装置。此外,如果在该通知中,被通知的带有CE标记的设备是“新产品”,制造商应在其通知中注明这一事实。

For the purposes of this Article, a device is ‘new’ if: 在本文中,如下是‘新设备’:

(a) there has been no such device continuously available on the Community market during the previous three years for the relevant analyte or other parameter; 在过去三年,在欧共体市场上没有持续供应相关分析物或其他参数的此类设备;

(b) the procedure involves analytical technology not continuously used in connection with a given analyte or other parameter on the Community market during the previous three years. 该程序涉及的分析技术在过去三年里没有与特定的分析物或共同体市场上的其他参数连续使用。

5. Member States shall take all necessary measures to ensure that the notifications referred to in paragraphs 1 and 3 are registered immediately in the databank described in Article 12. The procedures for implementing this Article and in particular those referring to the notification and the concept of significant change shall be adopted in accordance with the procedure referred to in Article 7. 会员国应采取一切必要措施,确保第1款和第3款所述的通知立即登记在第12条所述的数据库中。实施本条的程序,特别是提及通知和重大变更概念的程序,应按照第7条所述程序采取。

6. Transitionally, pending the establishment of a European databank accessible to the competent authorities of the Member States and containing the data relating to all devices available on the territory of the Community, the manufacturer shall give such notification to the competent authorities of each Member State concerned by the placing on the market.

过渡地,等待欧洲建立一个数据库访问包含数据的会员国和主管部门有关社区的领土上的所有设备,制造商应当给通知每个成员国的主管当局担心市场上放置。

 

 

五、CE marking 要求

1、除性能评估设备外,符合第三条所述基本要求的设备在投放市场时必须带有CE合格标志。

2、CE合格标志,必须以可视、易读和不可磨灭的形式出现在设备上(如果可行和适当)以及使用说明上。CE合格标志也必须出现在销售包装上。CE标志应附有负责执行附件III、IV、VI和VII所列程序的公告机构的标识号。

3、禁止在CE标志的含义或图形上添加可能误导第三方的标志或铭文。任何其他标记可以贴在设备上,包装上或设备的说明书上,只要CE标记的可见度和易读性不因此而减少。

六、ANNEX II LIST OF DEVICES REFERRED TO IN ARTICLE 9(2) AND (3)

设备分类清单

List A

— Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell, -用于确定以下血型的试剂和试剂产品,包括相关校准器和控制材料:ABO系统,rhesus (C, C, D, E, E) anti-Kell,

— reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D. 用于HIV感染(HIV 1和2)、HTLV I和II、乙型、丙型和丙型肝炎人类标本标志物检测、确认和定量的试剂和试剂产品,包括相关校准器和控制材料

List B

— Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: anti-Duffy and anti-Kidd, -用于确定以下血型的试剂和试剂产品,包括相关校准器和控制材料:anti-Duffy和anti-Kidd,

— reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies, 用于检测不规则抗红细胞抗体的试剂和试剂产品,包括相关校准器和控制材料,

— reagents and reagent products, including related calibrators and control materials, for the detection and quantification in human samples of the following congenital infections: rubella, toxoplasmosis, 试剂和试剂产品,包括相关校准器和控制材料,用于在人类样本中检测和定量下列先天性感染:风疹、弓浆虫病、

— reagents and reagent products, including related calibrators and control materials, for diagnosing the following hereditary disease: phenylketonuria, 用于诊断下列遗传性疾病的试剂和试剂产品,包括相关校准器和控制材料:苯丙酮尿症,

— reagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus, chlamydia, 用于确定以下人类感染的试剂和试剂产品,包括相关校准器和控制材料:巨细胞病毒、衣原体、

— reagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, B, 用于确定以下HLA组织组的试剂和试剂产品,包括相关校准器和对照材料:DR、A、B

— reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSA, 用于确定以下肿瘤标记物的试剂和试剂产品,包括相关校准器和控制材料:PSA、

— reagents and reagent products, including related calibrators, control materials and software, designed specifically for evaluating the risk of trisomy 21, 为评估trisomy 21风险而专门设计的试剂和试剂产品,包括相关校准器、控制材料和软件。

— the following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar. 一种用于自我诊断的装置,包括其相关的校准器和控制材料:血糖测量装置。

 

 

 

相关技术资料下载:

IVDD ANNEX I ESSENTIAL REQUIREMENTS基本要求

IVDD ANNEX III EC DECLARATION OF CONFORMITY - DOC自我声明

IVDD ANNEX V EC TYPE-EXAMINATION - EC型式检查

IVDD EC VERIFICATION - EC验证

IVDD认证工厂需要准备哪些技术资料TCF?

IVDD认证如何申请?

IVDD体外诊断医疗设备认证