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Class IIb Medical Devices (Conformity Assessment) – 验证评估程序——IIb 级

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For class IIb devices, such as infusion pumps, the manufacturer has to confirm one of the following procedures:

  • Conformity assessment procedure according to Annex II (complete Quality Managemenent System)
  • Conformity assessment procedure according to Annex III (EC type examination), which has always to be conducted together with one of the following procedures:
    • EC examination
    • EC declaration of conformity (Quality assurance production)
    • EC declaration of conformity (Quality assurance product)