UDI on medical device: Does it make other markings obsolete?

A

arturo_papito

#1
Hi everybody from barcelona,

Current situation: We print in our medical device boxes some data that has to be included in UDI. The expiry date (format AAA-MM) and the Batch. Also symbols associated to those concepts, “sand clock” for expiry date and a LOT for the batch.
We have Classes 3, 2 and 1.

Future: With UDI all that info must be incluced in a barcode attached to de device (normally a data matrix with also Human readable information at one side with GTIN, exp date, and batch).

It is “the same” logical info but in different format…so, with UDI what can I remove from current markings? The data, the symbols, both, none? It looks like the data could be removed as it is really duplicated…but the symbols?

Anyone has a clear picture? Does UDI make some of these other requierement obsolete? Which ones.
 
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rob73

looking for answers
#2
Hi Arturo
I am treating the UDI as an additional requirement, not a replacement. The LOT and expiry date (production identifiers) are not mandatory in the UDI therefore I think they should still appear on the packaing. If you want to include them in the UDI then it will need to be clear that what the numbers stand for. i.e in GS1 speak (10) is LOT or serial number, (17) is expiry date, so not imeadiatley clear to the user what they mean. It is a matter for your risk management process to decide if the risk of misinterpteration is acceptable or not.
 
A

arturo_papito

#3
Hi Arturo
I am treating the UDI as an additional requirement, not a replacement. The LOT and expiry date (production identifiers) are not mandatory in the UDI therefore I think they should still appear on the packaing. If you want to include them in the UDI then it will need to be clear that what the numbers stand for. i.e in GS1 speak (10) is LOT or serial number, (17) is expiry date, so not imeadiatley clear to the user what they mean. It is a matter for your risk management process to decide if the risk of misinterpteration is acceptable or not.
Thanks for the answer.

My idea about this was that we would use a datamatrix with the following information in HRI (for instance)
GTIN ( ) .....
LOT: (10)0000123456
Expir.date (17)201131 (in AAMMDD)

So the UDI-DI would be the GTIN and the UDI-PI the lot + expiry date

So from the point of view of the common sense it looks like other markings can be skippd, as they are "repeated" in meaning. But I am afraid that the regulation may make me keep the symbols (sand clock for expery date and LOT inside a square for the lot) and the data for the date in format AAAA-MM additionally.
 
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