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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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