UDI Carrier: Class A IVDs

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IVDR Compliance Date: Class A Sterile and Class B IVDs

15 May 2023

UDI Direct Marking: Low-Risk

15 May 2023

IVDR Compliance Date: Class A Sterile and Class B IVDs

15 May 2023

UDI Direct Marking: Low-Risk

15 May 2023

UDI carrier required on Class A IVD device labeling.

This is outlined in the IVDR: Article 113(e) establishes that Article 24(4) shall apply from 26 May 2027.

This requirement does not apply to IVDD legacy devices.

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