UDI Carrier: Class A IVDs

26 May 2027

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:

“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 IVDD legacy devices.

Details

Date: 26 May 2027
Event Tags:Labeling, Unique Device Identifier (UDI)

Other

Legislation: EU IVDR
Region: Europe

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