How should a UDI appear on the label or package of a device?

Modified on Wed, 28 Aug at 8:22 PM

The UDI Carrier in Automated Identification for Data Capture (AIDC) and human readable interpretation (HRI) formats shall be on the label or on the device itself and on all higher levels of device packaging.

In the event of significant space constraints on the unit of use packaging, the UDI carrier may be placed on the next higher packaging level.

Please note that shipping containers shall be exempted from the requirement.

For other specific requirements related to the UDI carrier, please consult Section 4 of Annex VI Part C of the EU MDR and IVDR Regulations.