UDI Carrier: Class B & C IVDs and Class I medical devices

UDI carrier is required on 1) MDR Class I device labeling, and 2) IVDR Class B and C IVD labeling.

This is outlined under:

• MDR Article 123(f): “for implantable devices and for class III devices Article 27(4) shall apply from 26 May 2021. For class IIa and class IIb devices Article 27(4) shall apply from 26 May 2023. For class I devices Article 27(4) shall apply from 26 May 2025″
• IVDR Article 113(e): “for class D devices, Article 24(4) shall apply from 26 May 2023. For class B and class C devices Article 24(4) shall apply from 26 May 2025. For class A devices Article 24(4) shall apply from 26 May 2027″

This requirement does not apply to MDD/IVDD legacy devices.