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I 类医疗器械的CE认证途径

I 类医疗器械的CE认证途径

I 类医疗器械的CE认证步骤

  1. 分类:确认产品属于I类医疗器械
  2. 选择符合性评估途径:请参考下面的流程图
  3. 编制技术文件
  4. CE符合性声明
  5. 委任欧盟授权代表
  6. 由欧盟授权代表将制造商及产品在欧盟主管机关注册
  7. 建立售后警戒系统/加贴CE标签并将产品投放市场

I  类医疗器械: CE 符合性评估途径

  1. 制造商有责任确保其产品符合93/42/eec指令的所有相关的基本要求,必须制定一份书面(自我)声明来保证。

  2. 不具备测量功能非灭菌的I类医疗器械(的CE认证过程中)不需要第三方公告机构(NB)参与。是否符合ISO13485:2003标准,由制造商自愿选择,并非强制性

  3. 具有测量功能灭菌类的I类医疗器械(的CE认证过程中)必须要有第三方公告机构(NB)参与。

  4. 一旦制造商认为其产品符合93/42/eec指令的所有相关的基本要求,(欧盟境内的)制造商,或者(欧盟境外制造商的)欧盟授权代表必须先在欧盟主管机关注册,然后才可加贴CE标签并将产品投放EEA市场。
Flow Chart of Class I MDD

Flow Chart of Class I MDD

Medical Devices MDD conformity assessment procedures table

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About CE Marking: