Active Implantable Medical Devices Directive

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| The Directive: AIMDD 90/385/EEC | Scope | Compliance |
| Notified Bodies for Active Implantable Medical Devices |
| New Regulation Proposal: 542/2012 Compliance |

{:en}The Directive: AIMDD 90/385/EEC{:}{:zh}指令: AIMDD 90/385/EEC{:}

in Active Implantable Medical Devices Directive

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AIMDD (Active Implantable Medical Device Directive) 90/385/EEC has been in place since June 20, 1990. This directive applies to devices according to Article 2.C AIMDD, which defines an active implantable medical device as:

“any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure” additionally the directive requires that all active implantable medical device manufacturers must affix CE-Marking to the Directive in order to place their devices on the European Market. The AIMDD 90/385/ EEC also mentions the language requirement issue in Article 4.4, “when a device is put into service, Member States may require the information described in sections 13, 14 and 15 of Annex I to be in their national language(s).”

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AIMDD (有源植入性医疗器械指令) 90/385/EEC 于1990年6月20日发布。此指令适用于根据2.C AIMDD条款规定的器械， 它将有源植入医疗器械定义为：

“任何有源医疗设备，它的目的是通过手术或药物全部或部分进入人体或通过医疗干预进入一个自然体腔，并在此操作后仍保留在体内（体腔内）的设备。

此外，该指令要求所有的有源植入式医疗设备制造商都必须此指令的要求贴上CE标志，以使他们的设备投入欧盟市场。AIMDD90／385／EEC还在第4.4条中提到语言要求问题，“当一个设备投入使用，成员国可以要求在附录I, 13，14和15节中所描述的信息为他们的本国语言“。

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{:en}Scope{:}{:zh}范围{:}

in Active Implantable Medical Devices Directive

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Medical devices (as a whole) include any instrument, appliance, software, etc. used for the purpose of prevention (e.g. vaccine-delivery devices), screening (e.g. mammography for breast cancer), diagnosis (e.g. use ultrasound system) treatment, or alleviation of disease. Medical devices are currently regulated under three main Directives covering:

  1. Active Implantable Medical Devices (AIMD),
  2. Medical Devices (MDD)
  3. In Vitro Diagnostic Medical Devices (IVDD)

AIMD is classified as a device which must rely on a source not provided by the body or gravity and be designed to be introduced into the body with the intention to remain there following the procedure. The directive specifies that these products should meet essential safety requirements in terms of function, sterility, material compatibility, marking, user instructions and design documentation. In addition there are requirements for type approval, production quality management, clinical investigation and manufacturer registration.

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{:}{:zh}医疗设备（作为一个整体）包括任何仪器，设备，软件等用于预防（例如，疫苗输送设备），筛选（如乳腺钼靶摄影对乳腺癌），诊断（如使用超声系统）治疗，或减轻疾病的设备。医疗设备目前受3个主要的指令监管：

1，有源植入式医疗器械（AIMD），

2，医疗器械（MDD）。

3，体外诊断医疗器械（IVDD）

AIMD分类为必须依靠一种不由身体或重力提供资源的设备，并且此设备要进入身体并在之后的过程中保留在身体里。该指令规定这些产品应在功能，无菌性，材料的兼容性，标记，说明书和设计文档方面符合基本的安全要求。此外还有对类型批准、生产质量管理、临床调查和生产登记方面的要求。

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{:en}Compliance{:}{:zh}合规{:}

in Active Implantable Medical Devices Directive

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Demonstrating CE compliance with the AIMDD requires CE certification by a Notified Body, which involves some of the following:

1. Essential Requirements

        • General requirements (” The devices must be designed and manufactured in such a way, that their use does not compromise the clinical condition or the safety of patients.”)
        • Requirements regarding design and construction

2. Manufacturer appoints a European Authorized Representative (2007/47/EC Article 10a(2))

3. CE Declaration of Conformity (Complete quality assurance system)

        • Quality system
        • Examination of the design of the product
        • Surveillance
        • Administrative provisions(the declaration of conformity)

4. EC Type- Examination

        • Make an application for evaluation of quality system to a notified body (Annex III, section 3)

5. EC verification

6. EC Declaration of Conformity to Type

        • Quality system
        • Surveillance

7. Statement concerning devices intended for special purposes

8. Clinical evaluation

9. Minimum criteria to be met when designating inspection bodies to be notified

10. Conformity of CE marking

Restriction of Hazardous Substances Directive

The RoHS Directive 2011/65/EU that came in to force on the 21st July 2011 has placed a restriction on the use of certain substances in electrical and electronic equipment of manufactured products including medical devices. The RoHS Directive has listed substances and their percentage restrictions which will apply to all electrical and electronic equipment in Annex II of this Directive. From the 22rd July 2014, all electronic and electrical equipment contained in medical devices must comply with the restrictions established in this Directive.

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{:}{:zh}证明CE符合AIMDD要求由公告机构提交CE证书，涉及以下方面的要求：

  1. 基本要求
    • 通用要求(” 设备必须被设计和制造为不危害临床病情或者病人的安全”)
    • 关于设计和施工的要求；
  1. 制造商指定一位欧盟授权代表(2007/47/ECArticle 10a(2))
  2. CE 符合性声明(完整的质量保证体系)
  • 质量系统
  • 产品设计的检查
  • 监督
  • 管理规定(符合性声明)
  1. EC 类别检查
  • 向公告机构申请质量系统检查 (附件 III, 第 3节)
  1. EC 验证
  2. EC 类别符合性声明
  • 质量体系
  • 监督

7.如设备有特殊目的则需有声明

  1. 临床研究
  1. 检查机构的最低标准
  2. CE标志符合性

 

Restriction of Hazardous Substances Directive

危害性物质限制指令

 

RoHS指令2011 / 65 /EU是在2011年7月21日强制实施的， 此指令限制了电气和电子设备在制造产品包括医疗设备时某些物质的使用。RoHS指令在附件II内列明了适用于所有电气和电子设备的限制物内容和比例。从2014年7月22日起，所有包含电子和电气设备的医疗器械必须符合本指令规定的限制条件。

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{:en}Notified Bodies for Active Implantable Medical Devices{:}{:zh}有源植入性医疗器械公告机构{:}

in Active Implantable Medical Devices Directive

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Notified Bodies are responsible for ensuring that all the active implantable medical devices brought to the EU Market are safe and compliant. They help the manufacturers by implementing conformity assessment procedures and granting conformity certificates. There are some expectations that a Notified Body must meet before being designated by the EU Authorities. Their main role is to review the technical documentations and approve the Design Dossiers for all AIMD. They decide whether or not to grant them EC-Design Examination Certificates. Selecting the most suitable Notified Body for an active implantable medical device is vital. Manufacturers can choose a Notified Body from the European Commission´s complete directory of Notified Bodies who are accredited for CE marking of active implantable medical devices. It is available on the NANDO website and the list contains more than 60 Notified Bodies from 22 countries (including Turkey and Australia). Nonetheless, selecting a Notified Body device can be a complex process. As such, it is also advised to have 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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{:}{:zh}公告机构在保证制造商只将安全和兼容的医疗设备投放在欧盟市场（EU MARKET）上发挥了关键的作用。他们通过实施合格评定程序，并向医疗器械授予合格证书来帮助制造商。公告机构需要满足一定的期望才能被欧盟当局指定。通过颁发CE证书或EC设计档案证书，他们的任务中一个关键方面是检查AIMDD设备的技术资料以及审查和批准设计文件。制造商可以查看欧盟委员会的完整公告机构目录（在NANDO website网站提供）。然而，由于选择一个公告机构可以是一个复杂的过程，我们也建议您可以由一个外部专家来协助您做这个关键的决定。有关医疗设备的公告机构的更多信息，请参阅我们的公告机构选择页面(Notified Body Selection page).。{:}


{:en}New Regulation Proposal: 542/2012 Compliance{:}{:zh}新法令提案：542，2012 承诺{:}

in Active Implantable Medical Devices Directive

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On April 2nd, 2014 the European Parliament adopted a resolution introducing 347 amendments to the European Commission’s proposal for a new Regulation on medical devices. This resolution introduces the amendments that were initially voted on 22 October 2013 on first reading of the Commission’s proposal.

In accordance with the co-decision procedure, the text is now under review of the Council for 1st reading. At this stage, 2 outcomes are possible:

    1. The Council may side with the Parliament’s position, in which case the legislative act will be adopted;
    2. The Council may amend the text adopted by the Parliament’s, and return the proposal to Parliament for a 2nd reading.

When the new text will be adopted, medical manufacturing companies will have to make sure they are in compliance with new CE marking requirements in order to lawfully affix the CE mark.

The key amendments introduced by the European Parliament to the Commission’s proposal for a new Regulation on medical devices are:

    1. Introductions of rules concerning the reprocessing of single use devices: all medical devices are to be considered reusable and suitable for reprocessing by default. Only devices that will be defined by the Commission as being ‘unsuitable for reprocessing’ may be single use.
    2. Involvement of the Special Notified Bodies in the conformity assessment procedures of high-risk devices (e.g. class III and implantable devices) that would be designated by the European Medicines Agency (EMA).
    3. Introduction of medical devices for aesthetic purposes within the scope of the proposal for a Regulation on medical devices.
    4. The Unique Device Identification system proposed by the Commission was endorsed by the Parliament.
    5. Introduction of a prior approval by competent authorities in order to prove conformity with general safety and performance requirements by other means than clinical data. The possibility to use non-clinical testing methods to prove conformity is restricted to low-risk devices.

It is still unsure whether the Council will support the above-mentioned points. Obelis, in its role of European Authorized Representative, is constantly watching legislative developments so as to make sure to provide medical manufacturing companies with the best advisory services on CE marking.

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{:}{:zh}2014年4月2日，欧洲议会通过了一项决议，对欧盟委员会提出的关于医疗器械新法规的347项修正案提出了建议。这项决议介绍了于2013年10月22日最初投票的委员会建议的修正案。

根据联合决策程序，文案现在已在进行理事会的初次审阅。在这个阶段，有2个结果是可能的：

  • 该理事会可能会与议会的立场相同，在这种情况下，立法行为将通过；
  • 委理事会可以修改议会通过的文案，并将提案交还给议会，进行第二读。

 

当新的文本将被采用时，医疗制造公司必须确保他们符合新的CE标志要求，以合法地贴上CE标志。

由欧洲议会向理事会提出的新的医疗器械法令的关键修改包括：

A.介绍关于一次性使用设备再加工的规则：所有的医疗设备都被认为是可重复使用的，并默认适用于再加工。只有被委员会定义为“不适合再处理”的设备可能是单次使用。

B.参与高风险设备（如III类和植入设备）合格评定程序的特殊公告机构将由欧洲药品管理局（EMA）指定。

  1. 在此医疗器械法令的规定范围内的美容用途医疗器械使用此法令。
  2. 由理事会提出的独特的设备识别系统得到了议会的支持。
  • 引进除了临床数据以外的，经主管机关事先批准，以证明符合一般的安全和性能要求的其他方式。使用非临床试验方法，以证明符合性的可能性被限制使用于在低风险的设备。

 

现今仍不确定理事会是否会支持上述观点。obelis，作为欧盟授权代表的立场，不断观察立法的发展，以确保提供医疗制造企业关于CE标志最好的咨询服务。{:}