Hi Anon
Assuming your question relates to EUDAMED...
True, the software does not enforce entry of packaging-level UDIs when a device is first entered. You can go back and add them later if you have any. If your device is only packaged as a single unit, you will never have a packaging-level UDI. If you design a new packaging level later, you can add it to EUDAMED then. If you discontinue one, you can mark it in EUDAMED as no longer placed on the EU market.
While entry of a packaging-level UDI into EUDAMED is optional, since some devices may not have any, if your device has more than a single packaging level, it is mandatory to assign UDIs at each level and enter them all into the database.
See the regulation, Article 27:
3. Before placing a device, other than a custom-made device, on the market, the manufacturer shall assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance with the rules of the issuing entity designated by the Commission in accordance with paragraph 2.
Before a device, other than a custom-made or investigational device, is placed on the market the manufacturer shall ensure that the information referred to in Part B of Annex VI of the device in question are correctly submitted and transferred to the UDI database referred to in Article 28.
And Annex VI:
The manufacturer shall provide to the UDI database the UDI-DI and all of the following information relating to the manufacturer and the device:
1. quantity per package configuration,
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Anne LeBlanc
United States
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Original Message:
Sent: 18-Apr-2022 14:31
From: Anonymous Member
Subject: UDI container package details
This message was posted by a user wishing to remain anonymous
Question -
Is it true that in the UDI device registration module it is not required to enter the UDI-DI's for all packaging levels? In the user guide it is stated that this information is optional to complete.
So only the device or device level (each) packaging UDI-DI is all that is needed?