欧盟医疗器械指令98&97

体外诊断医疗器械指令98/97/EC

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

欧盟议会和委员会体外诊断医疗器械 98/97/EC指令（1998，10.27）

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 100a there of, 关于建立欧盟的协定和100a的特别协议

Having regard to the proposal from the Commission (1),关于委员会的建议（1） Having regard to the opinion of the Economic and Social Committee (2),

关于经济和社会委员会的观点（2）

Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), 根据条约189b程序规定采取的方案(3) (1)Whereas measures should be adopted for the smooth operation 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;

鉴于内部市场的顺利运作而采取的措施；鉴于欧盟内部市场是产品、人员、服务以及资本运作自由活动的无边界区域

(2)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 and authorisation procedures for in vitro diagnostic medical devices are different; whereas the existence of such disparities creates barriers to trade, and whereas the need to establish harmonised rules has been confirmed by a comparative survey of national legislations carried out on behalf of the Commission;

在体外诊断医疗器械反面欧盟成员国在安全、健康保障和能力、特点和授权程序方面的法律法规以及行政规定的范围和内容存在差异性；鉴于差异性的存在而产生贸易壁垒，同时需要建立代统一和谐规则，其规则是委员会授权调查立法部门根据其调查比较后确认的。

(3)Whereas the harmonisation of national legislation is the only means of removing such

barriers to free trade and of preventing new barriers from arising; whereas this objective cannot be achieved in a satisfactory manner by other means by the

individual Member States; whereas this Directive lays down only such requirements as are necessary and sufficient to ensure, under the best safety conditions, free movement of the in vitro diagnostic medical devices to which it applies。

立法意在消除自由贸易的壁垒同时防止其不再产生，其目标的达成没能取得令各成员都满意的方式，其指令仅仅规定了以最安全的方式采取与之相适应的必要而足够措施的体外医疗器械的自由贸易活动。

体外诊断医疗器械指令98/97/EC

(4)Whereas the harmonised provisions must be distinguished from 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 harmonised provisions do not affect the ability of the Member States to implement such measures provided that they comply with Community law;

该协定条款有别于成员国直接或间接器械以发现公共健康和疾病的保险方案，因此其不影响成员实施该措施满足共同体法律的能力。 (5)Whereas in vitro diagnostic medical devices should provide patients, users and third

parties with a high level of health protection and attain the performance levels originally attributed to them by the manufacturer; whereas, therefore, maintenance or improvement of the level of health protection attained in the Member States is one of the main objectives of this Directive;

制造商提供给病人、使用者和第三方高水平的健康防护和能力的体外诊断医疗器械应该满足其预期能力，因此维护和改进他们获取该能力是本指令的目的。 (6)Whereas, in accordance with the principles set out in the Council resolution of 7 May

1985 on a new approach to technical harmonisation and standards (4), rules

regarding the design, manufacture and packaging of relevant products must be confined to the provisions required to meet the essential requirements; whereas, because they areessential, such requirements should replace the corresponding national provisions; whereas the essential requirements, including requirements to minimise and reduce risks, should be applied with discretion, taking into account the technology and practice at the time of design and technical and economic

considerations compatible with a high level of protection of health and safety;

根据1985,5月7日会议解决方案设定的原则采用了新方面和标准（4），规则，其产品的设计、制造、包装都强制满足其根本需求，包含最低要求和减少风险，应该谨慎选择、采用的技术和设计实践以及技术和经济考虑以满足高水平的健康和安全防护。

(7)Whereas the major part of medical devices are covered by Council Directive

90/385/EEC of 20 June 1990 on the approximation of laws relating to active

implantable medical devices (5) and Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (6) with the exclusion of in vitro diagnostic medical devices; whereas this Directive seeks to extend the harmonisation to in vitro

diagnostic medical devices and whereas, in the interest of uniform Community rules, this Directive is based largely on the provisions of the said two Directives;

欧盟指令90/385主要包括几乎所有的有源植入医疗器械（5），93/42指除体外医疗器械外的医疗器械（6），指令要求的体外医疗器械条款很大程度依赖于这两个指令。

(8)Whereas instruments, apparatus, appliances, materials or other articles, including

software, which are intended to be used for research purposes, without any medical objective, are not regarded as devices for performance evaluation;

设施、设备、器具、材料或其他用品，包含用于研究目的的软件，如果不是以医疗为目的就不被当做器械评估其能力

(9)Whereas, although internationally certified reference materials and materials used for

external quality assessment schemes are not covered by this Directive, calibrators

体外诊断医疗器械指令98/97/EC

and control materials needed by the user to establish or verify performances of devices are in vitro diagnostic medical devices; 尽管国际认证材料和用于品质内部评估方案的材料不是本指令所要求的范围，校验评估人眼需要建立和评估该类器械的性能。 (10) Whereas, having regard to the principle of subsidiarity, reagents which are

produced within health-institution laboratories for use in that environment and are not subject to commercial transactions are not covered by this Directive;

关于子原则，适用于健康机构实验室的试剂，其不以商业交换为目的不在本指令没有要求。

(11) Whereas, however, devices that are manufactured and intended to be used in a

professional and commercial context for purposes of medical analysis without being marketed are subject to this Directive;

然而，器械以专业和商业用途的医疗分析但没有在销售市场上的也属于本指令要求的范围 (12) Whereas mechanical laboratory equipment especially designed for in vitro

diagnostic examinations falls within the scope of this Directive and whereas,

therefore, in order to harmonise the relevant directives, Directive 98/37/EC of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machinery (7), should be appropriately amended to bring it into line with this Directive;

特别以实验设备为目的的医疗器械在其指令范围内，因此 98/37（98，6/2） 指令所有关于机械装置的法律条文都要修订与此指令保持一致。

(13) Whereas this Directive should include requirements regarding the design and manufacture of devices emitting ionizing radiation; whereas this Directive does not affect the application of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation (8);

此指令包含设计制造器械的离子辐射要求，因此次指令不影响96/29原子能应用领域指令关于工人健康的基本安全标准和离子辐射的公共危险保护.

(14) Whereas, since electromagnetic compatibility aspects form an integral part of the

essential requirements of this Directive, Council Directive 89/336/EEC of 2 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility (9) does not apply;

本指令设计的电磁兼容性方面的基本需求并不适用于89/336指令关于成员国的电磁兼容性的几乎所有法律条文 (15) Whereas, in order to ease the task of proving conformity with the essential

requirements and to enable conformity to be verified, it is desirable to have

harmonised standards in respect of the prevention of risks associated with the design, manufacture and packaging of medical devices; whereas such harmonised 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 Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) are

recognised as the competent bodies for the adoption of harmonised standards in

体外诊断医疗器械指令98/97/EC

accordance with the general guidelines on cooperation between the Commission and those two bodies signed on 13 November 1984; 为使更容易提供基本需求的一致性和验证， 在设计，制造和包转医疗器械时的风险预防方面标准的协同性，私立法律机构和组织应撤销其标准文本并保持无非授权文本。自此，根据1984,11/13委员会和这两家机构签订的通用合作指南，欧盟保准委员会和欧洲电子兼容委员会是认可的标准委员会。 (16) Whereas, for the purpose of this Directive, a harmonised standard is a technical specification (European standard of harmonisation document) adopted, on a mandate from the Commission, by CEN or Cenelec or by both of those bodies in accordance with Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (10), and pursuant to the above mentioned general guidelines; 该指令条文采用的技术规范是基于欧盟委员会和电磁兼容委员会或其二者根据98/34指令授权的程序信息及技术标准和规定。并采用以上提到的通用指南

(17) Whereas, by way of exception to the general principles, the drawing up of common technical specifications takes account of a current practice in some Member States

whereby for selected devices mainly used for the evaluation of the safety of blood supply and of organ donation, such specifications are adopted by the public authorities; whereas it is appropriate that these particular specifications should be replaced by

common technical specifications; whereas these common technical specifications can be used for performance evaluation and reevaluation;

除通用原则之外的方式，通用标准技术说明拟定考虑成员在选择器械用于评估输血和器官捐献的实际操作，类似的特殊规范适用于公共的权威授权机构，这些特别的规范应代替通用的技术规范；通用规范能用于其能力的评估和再评鉴.

(18) Whereas scientific experts from various interested parties could be involved in the drafting of common technical specifications and in the examination of other specific or general questions;

各领域的对此感兴趣的科学专家可以参与其通用规范的起草以及其他规范的检查或提出问题

(19) Whereas manufacturing, as covered by this Directive, also includes the packaging of the medical device, insofar as such packaging is related to the safety and performance aspects of this device;

医疗器械的制造和包装属于此指令的范畴，在此范围内的包装关系到包装安全和其性能方面

(20) Whereas certain devices have a limited life owing to the decline in their

performance over time, which is related, for example, to the deterioration in their physical or chemical properties, including the sterility or integrity of the packaging; whereas the manufacturer should determine and indicate the period during which the device will perform as intended; whereas the labelling should indicate the date until which the device or one of its components can be used with complete safety;

必然器械因为长时间导致性能下降而有其寿命限制，比如其物理或化学特性的退化，包含完成的包装或缺失。制造商应该决定和指示使用期限，并标注其器械或其零部件保证完全安全的时间期限。

体外诊断医疗器械指令98/97/EC

(21) Whereas, in Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives (11), the Council laid down harmonised conformity assessment procedures; whereas the details added to these modules are justified by the nature of the verification required for in vitro diagnostic medical devices and by the need for consistency with Directives 90/385/EEC and 93/42/EEC;

93/465决议关于其多方面符合性评估程序和CE符合性标贴规则，其适用条款为11，委员会界定了其统一的评估程序，其细节根据体外诊断医疗器械自然属性验证而定并与90/385和93/42的需要保持一致 (22) Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group in vitro diagnostic medical devices into two main product classes; whereas, since the large majority of such devices do not constitute a direct risk to

patients and are used by competently trained professionals, and the results obtained can often be confirmed by other means, the conformity assessment procedures can be

carried out, as a general rule, under the sole responsibility of the manufacturer; whereas, taking account of existing national regulations and of notifications received following the procedure laid down in Directive 98/34/EC, the intervention of notified bodies is needed only for defined devices, the correct performance of which is essential to medical practice and the failure of which can cause a serious risk to health

最根本和核心的目的是符合性评估程序将体外医疗器械整合成两个主要的产品等级，因此大部分主要器械不能替代病患者的直接风险和也不能替代受过培训的胜任专家使用。通常的规则是，符合性评估是制造者的唯一责任，其评估结果的获得可以是其他的方式。考虑到现有98/34指令法规要求和忠告性通知，报告机构组织仅需要定义器械作为医疗器械的正确性能以及失效导致的健康风险

(23) Whereas, among the in vitro diagnostic medical devices for which intervention of a notified body is required, the groups of products used in blood transfusion and the prevention of AIDS and certain types of hepatitis require a conformity assessment

guaranteeing, with a view to their design and manufacture, an optimum level of safety and reliability;

关于涉及到需要介入人体的体外诊断医疗器械，产品系类用于输血、艾滋病防御和某些肝炎病需要通过评估其设计、制造以保证安全和可靠性的最佳水平达到符合性保证。

(24) Whereas the list of in vitro diagnostic medical devices to be subjected to third-party conformity assessment needs updating, taking account of technological progress and of developments in the field of health protection; whereas such updating measures must be taken in line with procedure III(a) as laid down in Council Decision 87/373/EEC of 13 July 1987 laying down the procedures for the exercise of implementing powers conferred on the Commission (12);

体外诊断医疗器械的第三方符合性评估清单需要保持最新状态，考虑到健康防护领域的技术进步和发展，其最新的测量应该和委员会赋予的执行能力程序保持一致(87/373 程序III(a).

(25) Whereas an agreement on a modus vivendi between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in

体外诊断医疗器械指令98/97/EC

accordance with the procedure laid down in Article 189b of the Treaty was reached on 20 December 1994 (13);三方达成的执行方案妥协办法参考1994（13）条约189b条款

(26) Whereas medical devices should, as a general rule, bear the CE marking indicating 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; 通常贴有CE符合性标志的医疗器械根据指令规定可以在共同体内按照预期目的自由运输转移和交付服务。

(27) Whereas manufacturers will be able, when the intervention of a notified body is required, to choose from a list of bodies published by the Commission; whereas, although Member States do not have an obligation to designate such notified bodies, they must ensure that bodies designated as notified bodies comply with the assessment criteria laid down in this Directive; 当需要介入告知主体时，制造商能从委员会发布的清单中选择，成员国即使没有分派被告知主体的义务，但需要保证被安排的主体要符合指令标准的要求。

(28) Whereas the director and staff of the notified bodies should not, themselves or through an intermediary, have any interest in the establishments subject to assessment and verification which is likely to compromise their independence;

被告知主体的监管者或陪护人员-他们或他们的媒介，在建立评估和验证上应该没有厉害关系，需要承若其独立性。

(29) Whereas the competent authorities in charge of market surveillance should be able, particularly in emergencies, to contact the manufacturer or his authorised representative established in the Community, in order to take any protection measures that should prove necessary; whereas cooperation and exchange of information between Member States are necessary with a view to uniform application of this Directive, in particular for the purpose of market surveillance; whereas to that end it is necessary to establish and manage a database containing data on manufacturers and their authorised

representatives, on devices placed on the market, on certificates issued, suspended or withdrawn, and on the vigilance procedure; whereas a system of adverse incident reporting (vigilance procedure) constitutes a useful tool for surveillance of the market, including the performance of new devices; whereas information obtained from the vigilance procedure as well as from external quality assessment schemes is useful for decision-making on classification of devices;

为了采取任何有效的防护措施，特别是紧急情况，负责市场监督的权威机构应该能联系到其制造商或其授权代表；成员国之间为了信息交流与合作必须遵照指令的统一实施要求，尤其是市场监督方面；至此，有必要建立起数据库，其包含制造商、授权表，产品市场，执照颁发、暂停以及召回程序，预警系统和程序，有用的市场监督工具，新产品性能，内部品质评估方案，器械等级的决定等。

(30) Whereas it is essential that manufacturers notify the competent authorities of the placing on the market of 'new products` with regard both to the technology used and the substances to be analysed or other parameters; whereas this is true in particular of high-density DNA probe devices (known as micro-chips) used in genetic screening; 最根本的是制造者需要通知权威机构关于其投放市场的新产品在技术应用和分析的物质或其他的参数，尤其是高密度的DNA探测设备（众所周知的微芯片）在基因筛查中的应用。

体外诊断医疗器械指令98/97/EC

(31) Whereas, when a Member State considers that, as regards a given product or group of products, it is necessary, in order to protect health and safety and/or ensure compliance with the imperatives of public health, in accordance with Article 36 of the Treaty, to prohibit or restrict their availability or to subject it to special conditions, it may take any transitional measures that are necessary and justified; whereas, in such cases, the Commission consults the interested parties and the Member States and, if the national measures are justified, adopts the necessary Community measures, in accordance with procedure III(a) as laid down in Decision 87/373/EEC;

根据条约36条款，为了健康防护和安全或满足公共安全的必要，成员国必须考虑产品或产品系列的禁止或限制其使用或特殊条件项目，其必须采取必要和合理的过度措施。此种情况下，委员会问询利益相关方和成员国，如果措施是合理的，则根据87/373决议程序III(a)采用其必要的共同体措施。

(32) Whereas this Directive covers in vitro diagnostic medical devices manufactured from tissues, cells or substances of human origin; whereas it does not refer to the other medical devices manufactured using substances of human origin; whereas, therefore, work will have to continue in this connection in order to produce Community legislation as soon as possible;

指令涉及皮肤、细胞或神经组织物质的体外诊断医疗器械但不包含使用这些物质，因此还要尽快开展这方面相关的共同体立法工作

(33) Whereas, in view of the need to protect the integrity of the human person during the sampling, collection and use of substances derived from the human body, it is

appropriate to apply the principles laid down in the Convention of the Council of Europe for the protection of human rights and dignity of the human being with regard to the application of biology and medicine; whereas, furthermore, national regulations relating to ethics continue to apply人在取样、收集和使用人体的物质时关于人的健全保护需要，根据欧盟会议国际公约关于生物学和医疗应用方面，恰当的人权保护和尊严保护方面的伦理道德规定照常适用

(34) Whereas, in the interests of overall consistency between directives on medical devices, some of the provisions of this Directive should be incorporated into Directive 93/42/EEC, which needs to be amended accordingly;

(35) Whereas it is necessary to draw up as quickly as possible the legislation which is lacking on medical devices manufactured using substances of human origin,

HAVE ADOPTED THIS DIRECTIVE: 必须采用的指令

Article 1 Scope, definitions 范围，定义

1. 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.

此指令适用于体外诊断医疗器械及其附件，指令的目的，附件应该当做器械自身的部分。二者在下文中都称为器械。

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

体外诊断医疗器械指令98/97/EC

依据指令下列定义应该采用 (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:

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

- diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap, - investigation, replacement or modification of the anatomy or of a physiological process, - control of conception, 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;

“医疗器械”是指制造商打算给人使用为下列目的的任何设施、设备、器具，材料或其他物品，无论是否独立使用或一起使用，包含应用软件。

诊断、监控，预防，处置或减缓疾病诊断、监控、处置，减缓或伤害或残障补救 研究，代替或解剖修复或生理过程或怀孕控制

其不适用于意在人体或生理反应在内的药理学，生理学或新城代谢方式但可以是其功能的辅助方式 (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: - concerning a physiological or pathological state, or

- concerning a congenital abnormality, or

- to determine the safety and compatibility with potential recipients, or

- to monitor therapeutic measures.

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.

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;

体外诊断医疗器械是指试剂、试剂产品、口径测量仪、控制材料，套件、设施、设备、器具、仪器系统等，无论其单独或混合使用，供应商意在用于体外抽样检查、化验包含血液，组织捐献等为目的并在以下范畴

病理和生理状态；先天畸形；决定潜在治疗者的安全和兼容性；监控治疗措施

采样容器也被当做体外诊断医疗器械，采样容器无论真空与否，只要制造商意在用于诊断或检查为目的的人体的样本的储存与保存

体外诊断医疗器械指令98/97/EC

(c) 'accessory` means an article which, whilst not being an in vitro medical device, is intended specifically by its manufacturer to be used together with a device to enable that device to be used in accordance with its intended purpose.

For the purposes of this definition, invasive sampling devices or those which are directly applied to the human body for the purpose of obtaining a specimen within the meaning of Directive 93/42/EEC shall not be considered to be accessories to in vitro diagnostic medical devices;

附件是指不是体外诊断医疗器械的物品但制造商用于特定辅助器械正常使用为目的的物品，，此指令不包含93/42所指的直接植入人体或直接用于人体抽样目的的医疗器械 (d) 'device for self-testing` means any device intended by the manufacturer to be able to be used by lay persons in a home environment;

自检装置是指制造商意在用于家庭环境卧床的人使用的器械

(e) 'device for performance evaluation` means any device intended by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate environments outside his own premises;

能力评估器械是指以一种或多种实验研究课题或医疗分析或其他适宜的外部环境的能力评估为目的使用的器械

(f) 'manufacturer` 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.

制造者是指器械投放市场前具有设计、制造、包装或贴标签责任的自然人或法人主体，无论其是否本人执行操作或其第三方代表

The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as devices with a 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;

指令强制义务也适用于组装，包装，加工，整修或贴一种或多种完工产品或委派其检查其产品的自然人或法人，但不适用于那些已经组装或改装投放市场以使用为目的的病人 (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;

授权代表是指组织或团体明确指派的人，行动和被权威组织和机构明确宣布但不是本指令下的事后责任义务

(h) '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 for use and/or in promotional materials;

预期目的是指制造贴付的标签，指引或推销材料提供数据的器械的预期

体外诊断医疗器械指令98/97/EC

(i) '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 performance evaluation with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;。。。。

(j) 'putting into service` means the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended 。。。。。.

3. For the purposes of this Directive, calibration and control materials refer to any substance, material or article intended by their manufacturer either to establish

measurement relationships or to verify the performance characteristics of a device in conjunction with the intended use of that device. 。

4. For the purposes of this Directive, the removal, collection and use of tissues, cells and substances of human origin shall be governed, in relation to ethics, by the principles laid down in the Convention of the Council of Europe for the protection of human rights and dignity of the human being with regard to the application of biology and medicine and by any Member States regulations on this matter.

指令要求人体物质，组织，细胞移除，收集或使用都应该管理，欧盟议会在伦理方面， 生理学应用和医疗应用在人权和人类尊严保护方面的条款

5. This Directive shall not apply to devices manufactured and used only within the same health institution and on the premises of their manufacture or used on premises in the immediate vicinity without having been transferred to another legal entity. This does not affect the right of Member State to subject such activities to appropriate protection requirements.。。。。。

6. This Directive shall not affect national laws which provide for the supply of devices by a medical prescription.

指令不影响处方下的器械提供方面的法律

7. This Directive is a specific directive within the meaning of Article 2(2) of Directive 89/336/EEC, which shall cease to apply to devices which have complied with this Directive.

Article 2 Placing on the market and putting into service

Member States shall take all necessary steps to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied and properly installed, maintained and used in

accordance with their intended purpose. This involves the obligation of Member States to monitor the security and quality of these devices. This Article applies also to devices made available for performance evaluation.

成员国必须采取必要的步骤保证期符合指令的器械可以投放市场并及时交付恰当安装，维护和使用，它涉及成员国的监控安全和品质的义务，此条款也适用于器械的有效性能评估 Article 3 Essential requirements

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.

器械必须满足符合附件I相应的基本需求，考虑器械相关的预期目的

体外诊断医疗器械指令98/97/EC

Article 4 Free movement 自由运动

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 16 if these devices have undergone conformity assessment in

accordance with Article 9.

成员国在其领地内不能设置任何障碍阻碍贴有CE标志的产品（根据16款CE标签并符合9条款符合性评估）投放市场和服务提供

2. Member States shall not create any obstacle to devices intended for performance evaluation being made available for that purpose to the laboratories or other institutions listed in the statement referred to in Annex VIII if they meet the conditions laid down in Article 9(4) and Annex VIII. 成员国不能创造任何障碍阻碍关于符合附件8以及条款9（4）条件的在编实验室或其它机构进行性能评估

3. At trade fairs, exhibitions, demonstrations, scientific or technical gatherings, etc. Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that such devices are not used on specimens taken from the participants and that a visible sign clearly indicates that such devices cannot be marketed or put into service until they have been made to comply.

贸易事务，展览，演示，科学和技术集会等

成员国不能设置障碍阻止器械的展示，该器械不符合该指令但不以采集参见者样本为目的同时其显著标志该器械如果不全部符合要求绝不投放市场和服务

3. Member States may require the information to be supplied pursuant to Annex I, part

B, section 8 to be in their official language(s) when a device reaches the final user.根据指令附件I,B部分8节，产品到达最终用户时，成员国可以要求其提供的官方语言信息

Provided that safe and correct use of the device is ensured, Member States may

authorise the information referred to in the first subparagraph to be in one or more other official Community language(s).

为了保障安全正确的适用器械，成员国可以要求在第一小段，其有一种或多钟官方共同体语言信息

In the application of this provision, Member States shall take into account the principle of proportionality and, in particular:本条款的应用，成员国应该考虑其适用原则，特别是： (a) whether the information can be supplied by harmonised symbols or recognised codes or other measures;是否该信息以一致的符号或识别码或其他措施

(b) the type of user anticipated for the device.是否适用这预期的器械类型

5. Where the devices are subject to other directives concerning other aspects 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.器械满足提供CE标志的其他方面要求的要求在随后的有关于满足其他指令要求的指示说明

However, should one or more of these directives allow the manufacturer, during a

transitional period, to choose 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

体外诊断医疗器械指令98/97/EC

European Communities, must be given in the documents, notices or instructions required by the directives and accompanying such devices

而一个或更多指令容许制造者在过渡期选择其试用范围，CE标签需要指示其规定的范围，这种情况，指令的特别之处需要根据指令和相应器械产品在欧盟官方杂志发行书面的通知或指引。

Article 5 Reference to standards 参考标准

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 transposing the harmonised standards the reference numbers of which have been published in the Official Journal of the European Communities; Member States shall publish the reference numbers of such national standards.

2. If a Member State or the Commission considers that the harmonised standards do not entirely meet the essential requirements referred to in Article 3, the measures to be taken by the Member States with regard to these standards and the publication referred to in paragraph 1 of this Article shall be adopted by the procedure defined in Article 6(2).

3. Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices designed and manufactured in conformity with common technical specifications drawn up for the devices in List A of Annex II and, where necessary, the devices in List B of Annex II. These specifications shall establish

appropriate performance evaluation and re-evaluation criteria, batch release criteria, reference methods and reference materials.

The common technical specifications shall be adopted in accordance with the procedure mentioned in Article 7(2) and be published in the Official Journal of the European Communities.

Manufacturers shall as a general rule be required to comply with the common technical specifications; if for duly justified reasons manufacturers do not comply with those specifications they must adopt solutions of a level at least equivalent thereto.

Where, in this Directive, reference is made to harmonised standards, this is also meant to refer to the common technical specifications.

Article 6 Committee on Standards and Technical Regulations 标准和技术委员会

1. The Commission shall be assisted by the committee set up by Article 5 of Directive 98/34/EC.

2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.

The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.

The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account.

体外诊断医疗器械指令98/97/EC

Article 7 Committee on Medical Devices 医疗器械委员会

1. The Commission shall be assisted by the committee set up by Article 6(2) of Directive 90/385/EEC.

2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the

committee shall be weighted in the manner set out in that Article. The chairman shall not vote.

The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.

If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.

If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.

3. The committee referred to in paragraph 1 may examine any question connected with the implementation of this Directive.

Article 8 Safeguard clause 安全保证条款

1. Where a Member State ascertains that the devices referred to in Article 4(1), when correctly installed, maintained and used for their intended purpose may compromise the health and/or safety of patients, users or, where applicable, other persons, or the safety of property, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service. The Member State shall immediately inform the Commission of any such measures,

indicating the reasons for its decision and, in particular, whether non-compliance with this Directive is due to:

(a) failure to meet the essential requirements referred to in Article 3;

(b) incorrect application of the standards referred to in Article 5, insofar as it is claimed that the standards have been applied;

(c) shortcomings in the standards themselves

成员国追溯产品参考条款4(1),当产品不能达成其预期承诺的患者健康或安全，使用者，或其他使用人以及财产安全方面的预期目的而安全维护时，其应该采取所有恰当的短期措施召回或禁止或限制投放市场货交互服务，成员国应当立即通知委员会关于其采取的措施，说明采决定的原因，特别是因为如下因素导致不符合指令的情形：

a. 不能满足条款3要求的失效

b. 不适用条款5的标准，指出今后适用的标准

c. 他们在标准方面的不足

体外诊断医疗器械指令98/97/EC

2. The Commission shall enter into consultation with the parties concerned as soon as

possible. Where, after such consultation, the Commission finds that:委员会应该尽快进入相关方关心问题的磋商和质询，之后，委员会找到：

- the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the parties concerned, bring the matter before the committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the procedures referred to in Article 6; where the measure referred to in paragraph 1 is attributed to problems related to the contents or to the application of the common technical specifications, the Commission shall, after consulting the parties concerned, bring the matter before the Committee referred to in Article 7(1) within two months, - the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorised representative.

措施是适宜合理的，其立即通知最先涉及的成员和其他成员国，如果决定涉及到第一段相关的标准不足，如成员国根据条款6提出修正，委员会质询相关方关注点以后在两个月（根据条款6.1）内提请委员会。如果涉及到问题的内容和技术规范，成员国在会议前两月内提交委员会。

3. Where a non-complying device bears the CE marking, the competent Member State shall take appropriate action against whomsoever affixed the marking and shall inform the Commission and the other Member States thereof.

贴有CE标签的不合格的医疗器械，做决定的成员国应该采取恰当的措施防止他的贴付并通知委员会和他的其他成员。

4. The Commission shall ensure that the Member States are kept informed of the

progress and outcome of this procedure.

委员会要确保成员国一直知道信息的进程和最终结果

Article 9 Conformity assessment procedures 合规性评价

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.

除了附件II涵盖的所有医疗器械和其性能评估，为了CE标志的贴付，制造者应该遵循附件III程序，在产品投放市场前草拟欧盟符合性宣言

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. Instead of applying this procedure, the manufacturer may follow the procedure referred to in paragraphs 2 or 3

除附件II外的所有自测器械的性能评估，制造者优先草拟前述的合规性声明，同时满足附件III 6点的补充要求，制造者参照第二或第三段的程序而不是本程序

体外诊断医疗器械指令98/97/EC

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: (a) follow the procedure relating to the EC declaration of conformity set out in Annex IV (full quality assurance), or

(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).

附件II 清单A的器械除性能评估用途外，为了CE标签的贴付，要么 a. 根据附件4 全面品质保证程序相关的欧盟合规性声明，或者

b. 根据附件5 设定的欧盟型号审查而后根据附件6（生产品质保证）做出欧盟合规性声

明

2. 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:

所有附件II清单B的器械（除性能评估外的）制造者申请CE标志，遵循如下： (a) the procedure relating to the EC declaration of conformity set out in Annex IV (full quality assurance) or a. 根据附件4 全面品质保证程序相关的欧盟合规性声明 (b) the procedure relating to EC type-examination set out in Annex V couplet with:

根据附件5进行产品审核

(i) the procedure relating to EC verification set out in Annex VI, or

根据附件6验证器械

(ii) the procedure relating to the EC declaration of conformity set out in Annex VII

(production quality assurance).

根据附件7（生产品质保证）做出合规性声明

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.

产品性能评估的情况，制造商应该根据附件8的程序，在产品可用前做出声明。本规不影响涉及适用皮肤和身体物质的性能评估方面的伦理道德规定

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.

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

制造者要指导其授权代表宣传附件3,5,6,8程序

体外诊断医疗器械指令98/97/EC

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.

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.

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.

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.

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.

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.

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. Article 10 Registration of manufacturers and devices

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:

- of the address of the registered place of business,

- 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,

- 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.

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

体外诊断医疗器械指令98/97/EC

instructions for use when such devices are placed on the market and/or put into service within their territory.

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.

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.

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. For the purposes of this Article, a device is 'new` if:

(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;

(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.

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.

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.

Article 11 Vigilance procedure 预警程序

1. Member States shall take the necessary steps to ensure that any information brought to their knowledge, in accordance with the provisions of this Directive, regarding the incidents mentioned below involving devices bearing the CE marking is recorded and evaluated centrally:

(a) any malfunction, failure or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health;

(b) any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to in subparagraph (a), leading to systematic recall of devices of the same type by the manufacturer.

2. Where a Member State requires medical practitioners, the medical institutions or the organisers of external quality assessment schemes to inform the competent authorities

体外诊断医疗器械指令98/97/EC

of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorised representative, is also informed of the incident.

3. After carrying out an assessment, if possible together with the manufacturer, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of the incidents referred to in paragraph 1 for which appropriate measures, including possible withdrawal, have been taken or are contemplated.

4. Where, in the context of notification referred to in Article 10, a device notified, bearing the CE marking, is a 'new` product, the manufacturer shall indicate this fact on his notification. The competent authority so notified may at any time within the following two years and on justified grounds, require the manufacturer to submit a report relating to the experience gained with the device subsequent to its being placed on the market.

5. The Member States shall on request inform the other Member States of the details referred to in paragraphs 1 to 4. The procedures implementing this Article shall be adopted in accordance with the procedure referred to in Article 7(2).

Article 12 European databank

1. Regulatory data in accordance with this Directive shall be stored in a European

databank accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis.

The databank shall contain the following:

(a) data relating to registration of manufacturers and devices in accordance with Article 10;

(b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedure as laid down in Annexes III to VII;

(c) data obtained in accordance with the vigilance procedure as defined in Article 11.

2. Data shall be forwarded in a standardised format.

3. The procedures implementing this Article shall be adopted in accordance with the procedure laid down in Article 7(2).

Article 13 Particular health monitoring measures 特定健康监测措施

Where a Member State considers, in relation to a given product or group of products, that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed pursuant to Article 36 of the Treaty, the availability of such products should be prohibited, restricted or made subject to particular

requirements, it may take any necessary and justified transitional measures. It shall then inform the Commission and all the other Member States, giving the reasons for its decision. The Commission shall consult the interested parties and the Member States and, where the national measures are justified, adopt necessary Community measures in accordance with the procedure referred to in Article 7(2).

Article 14 Amendments to Annex II, and derogation clause 附件二的修订和减少条款

1. Where a Member State considers that:

(a) the list of devices in Annex II should be amended or extended, or

体外诊断医疗器械指令98/97/EC

(b) the conformity of a device or category of devices should be established, by way of derogation from the provisions of Article 9, by applying one or more given procedures taken from amongst those referred to in Article 9,

it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures. The measures shall be adopted in accordance with the procedure laid down in Article 7(2).

2. When a measure is to be taken in accordance with paragraph 1, due consideration shall be given to:

(a) any relevant information available from the vigilance procedures and from external quality assessment schemes as referred to in Article 11;

(b) the following criteria:

(i) whether total reliance has to be placed on the result obtained with a given device, this result having a direct impact on subsequent medical action, and

(ii) whether action taken on the basis of an incorrect result obtained using a given device could prove to be hazardous to the patient, to a third party or to the public, in particular as a consequence of false positive or false negative results, and

(iii) whether the involvement of a notified body would be conducive to establishing the conformity of the device.

3. The Commission shall inform the Member States of the measures taken and, where appropriate, publish these measures in the Official Journal of the European

Communities.

Article 15 Notified bodies

1. Member States shall notify the Commission and other Member States of the bodies which they have designated for carrying out the tasks pertaining to the procedures

referred to in Article 9 and the specific tasks for which the bodies have been designated. The Commission shall assign identification numbers to these bodies, hereinafter referred to as 'notified bodies`.

The Commission shall publish a list of the notified bodies, together with the identification numbers it has allocated to them and the tasks for which they have been notified, in the Official Journal of the European Communities. It shall ensure that the list is kept up to date.

Member States shall not be obliged to designate a notified body.

2. Member States shall apply the criteria set out in Annex IX for the designation of bodies. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonised standards shall be presumed to meet the relevant criteria.

3. Member States shall apply continual surveillance of notified bodies to ensure ongoing compliance with the criteria set out in Annex IX. A Member State that has notified a body shall withdraw or restrict that notification if it finds that the body no longer meets the criteria referred to in Annex IX. It shall immediately inform the other Member States and the Commission of any withdrawal of notification or any restriction placed on it.

体外诊断医疗器械指令98/97/EC

4. The notified body and the manufacturer, or his authorised representative established in the Community, shall lay down, by common accord, the time limits for completion of the assessment and verification operations referred to in Annexes III to VII.

5. The notified body shall inform the other notified bodies and the competent authority about all certificates suspended or withdrawn and, on request, about certificates issued or refused. It shall also make available, on request, all additional relevant information.

6. Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or where a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer. In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof. The Member State shall inform the other Member States and the Commission.

7. The notified body shall, on request, supply all relevant information and documents, including budgetary documents, required to enable the Member State to verify compliance with Annex IX requirements.

Article 16 CE marking CE标志

1. Devices, other than devices for performance evaluation, considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market.

2. The CE marking of conformity, as shown in Annex X, must appear in a visible, legible and indelible form on the device, where practicable and appropriate, and on the instructions for use. The CE marking of conformity must also appear on the sales packaging. The CE marking shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes III, IV, VI and VII.

3. It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking. Any other mark may be affixed to the device, to the packaging or to the instruction leaflet accompanying the device provided that the visibility and legibility of the CE marking is not thereby reduced. Article 17 Wrongly affixed CE marking 错误的标志贴付

1. Without prejudice to Article 8:

(a) where a Member State establishes that the CE marking has been wrongly affixed, the manufacturer or his authorised representative shall be obliged to end the infringement under conditions imposed by the Member State;

(b) where non-compliance continues, the Member State must take all appropriate

measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market, in accordance with the procedure in Article 8.

体外诊断医疗器械指令98/97/EC

2. The provisions stated in paragraph 1 shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive.

Article 18 Decisions in respect of refusal or restriction 拒绝或限制决定

1. Any decision taken pursuant to this Directive:

(a) to refuse or restrict the placing on the market or any making available or putting into service of a device, or

(b) to withdraw devices from the market,

shall state the exact grounds on which it is based. Such decisions shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the national law in force in the Member State in question and of the time limits to which such remedies are subject.

2. In the event of a decision as referred to in paragraph 1, the manufacturer or his authorised representative shall have an opportunity to put forward his point of view in advance, unless such consultation is not possible because of the urgency of the measure to be taken as justified in particular by public health requirements.

Article 19 Confidentiality 机密性

Without prejudice to national law and practice on medical secrecy, Member States shall ensure that all the parties involved in the application of this Directive are bound to observe confidentiality with regard to information obtained in carrying out their tasks. This does not affect the obligations of Member States and notified bodies with regard to mutual information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.

Article 20 Cooperation between Member States 成员国合作

Member States shall take appropriate measures to ensure that competent authorities charged with the implementation of this Directive cooperate with each other and convey to each other the information necessary to ensure application in compliance with this Directive.

Article 21 Amendment of directives 指令修订

1. In Directive 89/392/EEC, the second indent of Article 1(3), 'machinery for medical use, used in direct contact with patients` shall be replaced by the following:

'- medical devices,`.

2. Directive 93/42/EEC is hereby amended as follows:

(a) in Article 1(2):

- point (c) shall be replaced by the following:

'(c) "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:

本文来源：https://www.bwwdw.com/article/jcoe.html