In-Vitro Diagnostic Medical Device Directive

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| The Directive: IVDD 98/79/EC | Scope | Compliance |
| Notified Bodies for In-Vitro Diagnostic Medical Devices |
| New Regulation Proposal: 541/2012 Compliance |

{:en}The Directive: IVDD 98/79/EC{:}{:zh}体外诊断医疗器械指令{:}

in In-Vitro Diagnostic Medical Device Directive

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IVD 98/79/EC (In-Vitro Diagnostic Medical Device Directive) was published on October 7, 1998. It is separate from the Medical Device Directive with its own separate set of requirements for manufacturers wishing to place medical devices in the European Economic Area. This directive does not specifically list out the devices that fall under it. Rather, the responsibility is placed on the manufacturer to determine what directives apply to their device. The directive sets out device requirements, requirements for manufactures placing the device on the market, and also demands on safety and quality of the devices.

Under the IVDD 98/79/EC, an In-Vitro Diagnostic Medical Device is defined as “any medical device which is a reagent, reagent device, 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 state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients”.

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{:}{:zh}IVD98/79/EC(体外诊断医疗器械指令)在1998年10月7日发布，它从医疗器械指令中剥离开来，对准备将医疗设备投放在欧盟市场的制造商有一系列单独的要求。该指令并没有明确列出它所覆盖的范围。相反，制造商有责任来确定哪些他们的设备适用此指令。该指令规定了设备的要求，制造商将设备投放入市场中的要求，也对设备的安全和质量提出了要求。

在Doc_IVD_98.79.EC下，体外诊断医疗器械被定义为“任何医疗设备，其为一种试剂，试剂设备，校准器，控制材料，医疗包，仪器，装置，设备或系统，无论是单独使用或组合使用的，制造用途为体外试样的检查：包括取自于体内的血液和组织，完全或主要用于提供关于健康状况或者疾病或者先天性畸形的信息或者确定潜在接收者的安全性与兼容性。

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{:en}Scope{:}{:zh}范围{:}

in In-Vitro Diagnostic Medical Device Directive

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The directive applies to In-Vitro Diagnostic Medical Devices and their accessories. Whereas it is assumed that accessories shall be treated as In-Vitro Diagnostic Medical Devices in their own right.

Certain devices are excluded from the scope of the directive.  According to Article 1 of the directive, a decision whether a device is within the scope of the directive will depend upon the intended purpose of the device and the claims for it.

“For research use only” devices are not usually considered to be IVD medical devices.  This means that the device must have no medical intended purpose, no medical objective and it should not have a performance evaluation function.

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{:}{:zh}该指令适用于体外诊断医疗器械及其配件。而假定配件也应在体外诊断医疗器械范围内。
某些设备被排除在指令的范围外。根据该指令的第1章，判定设备是否是该指令的范围内将取决于设备的预期目的和它的宣称用途。
“仅用于科研”的设备通常不被认为是体外诊断医疗器械。这意味着该设备必须没有医疗倾向目的，没有医疗主旨，它不应该有性能评价功能

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{:en}Compliance{:}{:zh}合规{:}

in In-Vitro Diagnostic Medical Device Directive

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Each In-Vitro Device manufacturer must develop their own compliance program which addresses their particular device categories and business needs. The following are general steps to compliance:

  • Determination of the applicable standards (European, International or National)
  • Assessment and classification of your device (depending on the specific function of an In-Vitro Diagnostic Medical Device and whether or not it is listed in Annex II)
  • Identification of the appropriate conformity assessment module according to your device classification
  • Preparation of a “Technical File” including a user manual (Annex III, section 3)
  • Implementation of “Quality Assurance System” (Annex III, section 4)
  • Selection of a Notified Body within the European Economic Area to perform the official conformity assessment tasks
  • Preparation of an “EC Declaration of Conformity”
  • Affixing of the CE Marking in accordance with the directive

For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community

The European Standards that are presumed by the European Commission to provide technical definition for demonstrating conformance to the “essential requirements” in the directive are published in the “Official Journal of the European Community”. While other national, regional or international standards can be used as well, European Standards are preferred since they are presumed by the European Commission to address the “essential requirements” contained in the directive.

Manufacturers should test your device, determine its conformance to the appropriate legal requirements and construct a corresponding Technical File that should be available in the European Economic Area. Manufacturers also need to affix the required “CE Marking” Logo to the device before placement in the market. In many cases, manufacturers can self-certify that their devices meet the legal requirements contained in the directive. In most instances, such a self-certification requires the use of European Standards.

The “Declaration of Conformity” must be prepared and must contain the following information:

  • The manufacturer’s name and full address, telephone, fax numbers and e-mail
  • The European Directive complied with
  • Device identification
  • Standards used to verify compliance with the directives
  • Name of “Notifying Body” and its identification number
  • The “Authorized Representative’s” name and full address, telephone, fax numbers and e-mail

The “Declaration of Conformity” and the “Technical Files” need only be written in “English”. However, instruction manuals need to be in the local language of the end user.

The European Competent Authorities are the local regulating bodies in each member state responsible for fulfilling the obligations of market control. All IVDs require notification to the Competent Authorities and a European Authorized Representative for each device placed on the market. The Notified Body will issue the appropriate certification after an exhaustive assessment to ensure that all relevant requirements have been met. Subsequently, manufacturers can place the CE marking on their devices demonstrating their compliance with the requirements.

Notification procedure for IVDs:

Any manufacturer who places a device on the European market has to notify the competent authorities of each Member State concerned by that placing on the market

For non-EU manufacturers:

  • This action can only be completed through a designated European Authorized Representative who will notify the competent authorities of that placing on the European Economic Area,
  • European Authorized Representative will then equip a non-EU manufacturer with “A certificate of CE Registration” which will demonstrate the submission of files to the European Authorities. From this point a non-EU manufacturer may place the device on the market

For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.

Non-Compliance

The directive portrays European Law enforced within the EEA; non-compliance with the directive’s requirements will result in the removal of the device from the market and the revoking of the CE marking affixed on the device.

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{:}{:zh}每个体外设备制造商必须指定满足其特定的设备类别和业务需求的合规计划。以下是需遵循的一般步骤：
•    确定适用标准（欧洲，国际和国内）
•    设备的评估和分类（根据一个体外诊断医疗器械的具体功能和它是否被列入附录II）
•    根据你的设备类别确定相对应的合格评定模块。
•    准备“技术文件”，包括用户手册（附录III，第3节）
•    执行“质量保证体系”（附录III，第4节）
•    选择欧洲经济区内的公告机构来进行正式的合格评定任务
•    准备“EC符合性声明”
•    根据指令加贴CE标志。

对于非欧盟制造商：指定设立在欧盟的欧盟授权代表。

欧盟委员会预计发布于“欧盟官方公报“的欧洲标准能提供证明符合此指令中的“基本要求”的技术定义。
而其他国家，地区或国际标准也可以采用，欧洲标准是首选，因为欧盟委员会预计以此推行包含在指令中的“基本要求”。
.制造商应测试设备，确定其是否符合相应的法律要求和并建立一套在欧盟可用的技术文件。

制造商还需要在设备上市前贴上所需的“CE标志”。在许多情况下，制造商可以自我认证其设备符合包含在该指令里的法定要求。在大多数情况下，这样的自我认证要求使用欧洲标准的。

“符合性声明“必须具备，并且包含以下信息
•    制造商的姓名，地址，电话，传真和邮箱
•    符合的欧盟指令
•    设备标识
•    用来验证是否符合指令的标准
•     “公告机构”名称和它的识别号码
•     “授权代表的”名称和详细地址，电话，传真和电子邮件

“符合性声明”和“技术文件”只需要用“英语”书写。然而，说明书需要使用最终用户的当地语言。
欧盟主管机构是各会员国的地方调节机构，负责履行市场管理的义务。对于投放市场的每个体外诊断设备，均要求通告主管部门和欧盟授权代表。公告机构应在详尽的评估后发出相应的证书，以确保所有相关的要求已得到满足。随后，制造商可以在其设备上加贴CE标志以说明他们的符合相关规定。

体外诊断医疗器械通告程序

任何投放设备在欧盟市场上的制造商必须要通告所投放市场的各会员国的主管机构。
对于非欧盟制造商
•    这个行动只能通过指定的欧盟授权代表来完成，它将通知主管机构关于此市场投放，
•    欧盟授权代表将会发给非欧盟制造商一份“CE注册证书”，证明已提交文件到欧洲当局。通过这点非欧盟的制造商才能将设备投入市场
对于非欧盟制造商：指定欧共体内设立的一个欧洲授权代表。

不合规

此法令描述了在欧盟经济区内的欧盟法律强制要求；与此法令不符的设备将会被清除出欧盟经济区(Doc_Legislation_MD_93.42.EEC)

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Notified Bodies for In-Vitro Diagnostic Medical Devices

in In-Vitro Diagnostic Medical Device Directive

Notified Bodies are tasked with ensuring that all the in-vitro diagnostic medical devices placed on the EU Market are safe and compliant. They assist the manufacturers to carry out conformity assessment procedures and grant conformity certificates to in-vitro diagnostic medical devices. There are certain criteria that a Notified Body must meet before the EU Authorities can designate them. Their role mainly consists of inspecting the technical documentations of Self-Testing IVD medical devices and IVDs listed on the Directive’s Annex II (list A and list B). Selecting a Notified Body for an in-vitro diagnostic medical device is an important process. Manufacturers can consult the European Commission´s complete directory of Notified Bodies (available on the NANDO website). However, as selecting a Notified Body device can be a complex process, it is also advised that an external expert supports this critical decision. For more information about Notified Body for in-vitro diagnostic medical devices, please see our Notified Body Selection page.

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{:en}New Regulation Proposal: 541/2012 Compliance{:}{:zh}新法规提议：541/2012承诺{:}

in In-Vitro Diagnostic Medical Device Directive

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A Proposal for a new Regulation on In-Vitro Diagnostic Medical Devices has been adopted by the European Commission on 26 September 2012 in the context of a broader revision of the regulatory framework for Medical Devices.

The proposal is currently undergoing the Ordinary Legislative Procedure. It has been adopted by the European Parliament on 2 April 2013 and shall now be discussed by the Council.

The main novelties proposed consist in:

  • Clearer and broader scope for the IVD legislation, in particular with regard to:
      • High-risk devices manufactured and used within a single health institution, which are subject to most of the requirements set out in the proposal;
      • Tests providing information about the predisposition to a medical condition or a disease (e.g. genetic tests) and tests providing information to predict treatment response or reactions (e.g. companion diagnostics), which are considered as in vitro diagnostic medical devices;
      • Medical software, which is explicitly mentioned in the definition of IVDs.

 

  • Clear definition and explicit identification of the respective tasks of the different Economic Operators (namely the manufacturer, the authorized representative, the importer and the distributor).

 

  • Stricter obligations for the manufacturer, which are proportionate to the risk class of the devices they produce. This implies – for example that:
      • All manufacturers should have a quality management system (QMS) in place to ensure that their products consistently meet the regulatory requirements;
      • QMS-related responsibilities are stricter for manufacturers of high-risk devices than for manufacturers of low-risk devices;
      • The Manufacturers is the sole responsible for the drawing up of the key-documents for the aimed at demonstrating the compliance with the legal requirements of each device placed on the market. These are the technical documentation and the EU declaration of conformity.

 

  • Specific provisions concerning product’s traceability consisting of:
      • A requirement that manufacturers fit their devices with a Unique Device Identification (UDI) which allows traceability;
      • A requirement that manufacturers/authorized representatives and importers shall register themselves and the devices they place on the EU market in a central European database;
      • An obligation for manufacturers of high-risk devices to make publicly available a summary of safety and performance with key elements of the supporting clinical data;
      • Further development of the European databank on medical devices (Eudamed),

 

  • Clear identification of the general requirements for clinical evidence for in vitro diagnostic medical devices which are proportionate to the risk class.
      • For the purpose of the Regulation ‘clinical evidence’ means the information that supports the scientific validity and performance for the use of a device as intended by the manufacturer
      • Manufacturer will always need to demonstrate the products’ conformity with the general safety and performance and the intended purpose of the device on the basis of clinical evidence.

 

 Moreover the proposed Regulation shall introduce some new concepts the field of IVDs:

  • Requirement for the manufacturers to have a qualified person within their organization. The ‘qualified person’ should be responsible for regulatory compliance;
  • Identification of clear conditions for the relabeling and/or repackaging IVDs.

 

Under the proposed Regulation the general obligations of the manufacturer shall consist in:

  • Ensure the product compliance with the relevant essential requirements;
  • Draw up the Technical Documentation, the Declaration of Conformity and the other documents aimed at demonstrating the product’s compliance with the EU legislation
  • Carry out the necessary conformity assessment procedures (that may vary in proportion with the level of risk of the concerned device).

 

Manufacturer established outside the European Union MUST appoint an European Authorized Representative.

 

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{:}{:zh}欧盟委员会于2012年9月通过了一项关于体外诊断医疗器械的条例提案，此提案对医疗器械的法令框架进行了大范围修改。
该提案目前正在普通立法程序，已经在2013年4月2日通过了欧洲议会，现在要由理事会进行讨论。
提出的新颖观点包含：
•    对于IVD立法更清晰，更广泛，特别是在
•    用于制造和使用于一个单独医疗机构的高风险设备，其受制于大部分此提案的要求。
•    用以提供有关倾向信息的医学病症或疾病（例如遗传测试）的测试；用于提供关于预测治疗响应或反应（例如伴随诊断）信息的测试，其被认为是体外诊断医疗设备;
•    医疗软件，在体外诊断医疗器械指令中明确提到。
•    明确的定义和清晰的界定了关于不同经济经营者（即制造商，授权代表，进口商和经销商）的各自任务。
•    严格了制造商的义务，这与他们生产的设备类型之风险是成比例的。这意味着 – 例如：
•    所有制造商应该有一个质量管理体系（QMS），以确保他们的产品持续符合监管要求
•    QMS有关的责任对高风险设备制造商比对低风险设备制造商更严格
•    制造商是唯一对用于证明每个投放市场的设备都符合法律规定的关键文件进行拟定需    要负责的一方。它们是技术文件和欧盟符合性声明
•    关于产品的可追溯性的具体规定包括：
•    制造商的设备符合唯一设备标识（UDI）以使其可追溯性
•    生产商/授权代表和进口商应在欧盟中央数据库中登记自己和他们投放在欧盟市场上设备
•    高风险设备制造商有义务使一份概要公开可得，此概要中设备的安全性和性能的关键要素有临床数据支持。
•    医疗器械欧洲数据库的进一步发展

•    清楚鉴定了体外诊断医疗器械相对应的风险级别的关于临床证据的一般要求，
•    “临床证据”法规的目的是指支持制造商预期的此设备的科学有效性和性能的信息。
•    制造商总是需要证明产品符合一般的安全性和性能，以及基于临床证据的预期目的。

此外，该法规提案将引入一些有关体外诊断医疗器械的新概念：
•    要求各制造商有自己组织中的合格人员。合格的人应负责合规性;
•    鉴定重新贴标签和/或重新包装体外诊断医疗设备的明确条件

根据法令提案，制造商的一般义务应包括：
•    确保产品符合相关基本要求
•    拟定技术文档，符合性声明和其他文件，旨在证明该产品符合欧盟法规
•    Carry out the necessary conformity assessment procedures (that may vary in proportion with the level of risk of the concerned device).
进行必要的合格评定程序（根据不同的该设备风险级别而不同）。
欧盟以外的制造商必须指定一名设立于欧盟的欧盟授权代表。

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