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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)