UDI and EAN

[ines ha]

hello,
I have 2 questions concerning UDI please:
1. can the UDI and the data matrix replace the EAN and barcode that is already on our product boxes so that this EAN can be removed ?
2. I know that shipping containers are exempt from UDI however as a manufacturer we put a number of Pcs of a product in a a carton so it can be sent to our clients (distributors) however the product will not be sold under this form to the final user. is this carton considered as a shipping container or a higher packaging that needs another UDI?

thank you in advance

 

[Cybel]

Hello!
I'm familiar with GS1 only so I use them as reference, I'm not sure about other issuing agencies but I think they are aligned.

1. From the GS1 General Specifications Standard https://gs1it.org/content/public/f5...3-982c88f28037/general_specifications_v24.pdf, par 4.15.2: "A GS1 DataMatrix, QR Code (GS1 Digital Link URI) or Data Matrix (GS1 Digital Link URI), SHALL be used in addition to the EAN/UPC, or a GS1 DataBar retail POS family of barcodes, to ensure stakeholders that are not yet able to consistently scan 2D barcodes are not negatively impacted."
I've been recommended by my GS1 contact person to still use both GS1 datamatrix for UDI and EAN/UPC for logistic purposes. Important: all GS1 data carriers (the one in the GS1 datamatrix and the one in the EAN/UPC) on a single trade item SHALL encode the same GTIN.

2. I think your carton is considered as a shipping container/logistics unit (used "for shipping or to protect the individually packaged devices" - art. 3.2, part C, Annex VI of MDR. You may check also this (bold is mine): under the GS1 General Specifications, a logistic unit is an item of any composition established for transport and/or storage which needs to be managed through the supply chain. Logistic units take many forms, a single box containing a limited number of products, a pallet of multiple products, or an intermodal container containing multiple pallets.
https://www.gs1.org/sites/default/f...ition-papers/gs1_udi_guide_final_20170324.pdf

Hope it helps.

 

[ines ha]

thank you Cybel this helps a lot. following your answer I have one more point to confirm please: is it obligatory to have the same GTIN in the UDI and EAN codes because we did this with 2 different ways so we obtained different codes

 

[Cybel]

This is what I know and you can verify it in par. 4.15.1, point 2 of the same link: https://gs1it.org/content/public/f5...3-982c88f28037/general_specifications_v24.pdf
Take a look also to the following paragraphs 4.15.2 and 4.15.3.
I guess it is a matter of traceability and accurate data association.
What is some retailer can read both? He should not find any difference between them, they should be interchangeable, which is not possible if they have different GTIN.