Begin Marketing in Europe
December 8, 2023CH REP: Add Directly to IVDR Labels
January 10, 2024
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.