IVDR Compliance Date: Class A Sterile and Class B IVDs
15 May 2023UDI Direct Marking: Low-Risk
15 May 2023UDI 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.