Classify your IVDClassify your IVDClassify your IVDClassify your IVD
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Begin Marketing in Europe
December 8, 2023
CH REP: Add Directly to IVDR Labels
January 10, 2024

Classify your IVD

December 8, 2023

Devices are classified according to a set of risk-based ‘rules’ under IVDR Annex VIII: Class A, B, C and D

 

  • If the IVD is Class A sterile, Class B, Class C or Class D, it will require a formal CE Certificate issued by a European Notified Body.
  • If the device is Class A non-sterile, the manufacturer will ‘self-certify’ the IVD.
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