UDI-DI and UDI-PI labelling


Starting to get Involved
Although I have been reading through numerous UDI treads and UDI guidelines, I still have a problem applying the regulation in practice.
I'd therefore appreciate any input on the following.

Today, our product is an over the counter sold metal cannister (spray) in a carton box.
  • The cannister contains a primary label with name and brand info, the bottom of the cannister has a directly printed HRI batchlot nr and expiry date in HRI format only
  • the secondary packaging is a carton box with GTIN barcode containing UDI-DI like data.
Do i understand it correctly that in order to comply to the UDI regulation:
  • Our cannister should have both UDI-DI and UDI-PI
    • Does this need to be in 1 carrier? Can we eg print the UDI-DI information on the primary label and the UDI-PI information on the bottom of the cannister as we do today?
    • Would it be ok if the UDI-PI would be printed in HRI format only?
  • Our secondary package would have a UDI-DI only, this UDI-DI is differs from the one printed on the primary label as it is a higher level of packaging
Your input is much appreciated!


Involved In Discussions
UDI-PI you can think it as SN number, normally only ClassIIB or Class III high risk products need to use it. Others use LOT is ok.

UDI-DI you can think it as model number .

GTIN is your factory ID number, which is part of UDI-DI. No need to print it on label separately.

In this case , your minimum products A need to put into a box B. Let’s say there are 10 pcs A in one box B.

You need UDI-DI for your A, which means one pcs of A;
You also need another UDI-DI for B, which means a box of B or 10 pcs of A.
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