Higher level of packaging UDI-PI

[indre.jur]

Hello
I have some questions about EUR MDR higher level of packaging UDI.
For example there is a higher level case of 120 units of products with their own package and UDI. So as I understand there should be a new UDI on this case of 120 units. UDI-DI part: a new GTIN will be generated in GS1.
But what about UDI-PI part? There should be specified for example: Lot Number, Exp. Date? What if there would be same products with different Lot Numbers? What then should be specified in UDI-PI part?
I hope someone will understand my question and will answer me.
Thank you in advance!

 

[Billy Milly]

UDI-DI is fixed for the device and packaging level. It does not change. In your case, 1 UDI-DI for #1 and 1 (different) UDI-DI for #120.
UDI-PI includes production information. Its content (data) changes with every batch. Same for all levels of packaging.

HTH

 

[Cybel]

UDI is made of both UDI-DI and UDI-PI. There is not such a thing as a UDI only made of UD-DI, so I guess the UDI-PI shall be indicated in the high level case of 120 units and reflect the UDI-PI of the single units inside.

I understand your issue; in our company we take care to put in the same case only units with same lots and expiry date, but we've considered to specify in our outer label something as:

This case contains:
- XXX units with lot XXX and expiry date XXXX
- YYY units with lot YYY and expiry date YYYY

adding the UDI barcode for both.

However, if your higher level case of 120 units is only a container for shipping (for example because you receive orders of multiple products), it does not require UDI.

 

[Ed Panek]

For Eudamed I think they only require the UDI-DI so you arent adding tens of identifier to the database.

 

[indre.jur]

UDI is made of both UDI-DI and UDI-PI. There is not such a thing as a UDI only made of UD-DI, so I guess the UDI-PI shall be indicated in the high level case of 120 units and reflect the UDI-PI of the single units inside.

I understand your issue; in our company we take care to put in the same case only units with same lots and expiry date, but we've considered to specify in our outer label something as:

This case contains:
- XXX units with lot XXX and expiry date XXXX
- YYY units with lot YYY and expiry date YYYY

adding the UDI barcode for both.

However, if your higher level case of 120 units is only a container for shipping (for example because you receive orders of multiple products), it does not require UDI.

Thank you for your answer.

Case of 120 units is not a shipping cointeiner. It's only a higher level boxe. I think we will try to put in the same case only units with same lots and expiry date. It would be simpler that way.

But please can you tell me more about this part:

but we've considered to specify in our outer label something as:
This case contains:
- XXX units with lot XXX and expiry date XXXX
- YYY units with lot YYY and expiry date YYYY
adding the UDI barcode for both.

If I understand correctly you would add one UDI barcode for both lot? But wich one lot and exp. date will be added in UDI-PI part?
Or two separate UDI barcodes for every new lot?

 

[EmiliaBedelia]

The PI for the upper level box should reflect what your actual production controls are and how you label the device. I do not think there is a requirement for the PI to be the same across all levels of packaging, so IMO you do not need to include the lower level PI information in the upper level UDI.

What do you do now? Does the larger box have a separate lot code and separate production process from the smaller boxes? Do you indicate the expiry date on the 120-pack? If, on the larger box, you do not indicate an expiry date, I would not put it in the PI. If you do indicate an expiry date, that would need to be in the PI. MDR specifies that if a PI (lot, serial, expiry, mfg. date) appears on the label, it needs to be in the PI, so I would start there.

It sounds like in your process, you pack the unit level packages, and then at a separate time/date you pack the 120-unit packages. I would consider them to have their own unique lot code and production information, separate from the lower level.

I understand your issue; in our company we take care to put in the same case only units with same lots and expiry date, but we've considered to specify in our outer label something as:

This case contains:
- XXX units with lot XXX and expiry date XXXX
- YYY units with lot YYY and expiry date YYYY

adding the UDI barcode for both.

Is this a "shipping container" or is this case a trade item in itself? If it's a trade item, it needs a unique DI.
Is the case labeled with its own unique UDI in addition to the unit level UDIs?
I'm curious why you include the lower level expiry dates and lot info...

 

[Cybel]

Is the case labeled with its own unique UDI in addition to the unit level UDIs?
I'm curious why you include the lower level expiry dates and lot info...

If the 120 unit case is stored in a warehouse, I should keep traceability of lot and expiry date of all the devices inside, for the time of storage.

I do not think there is a requirement for the PI to be the same across all levels of packaging

You are right, MDR states that "The UDI-DI shall be unique at each level of device packaging", no words about UDI-PI.
But how can you keep traceability if the PI changes?

If I understand correctly you would add one UDI barcode for both lot? But wich one lot and exp. date will be added in UDI-PI part?
Or two separate UDI barcodes for every new lot?

Sorry, I meant I would add two separate UDI barcodes. But I don't know if this can work and can be accepted, we evaluated this possibility in the first place but we've decided that is definitely better to avoid to mix lots in the same case.

For Eudamed I think they only require the UDI-DI so you arent adding tens of identifier to the database.

Yes, but you shall provide the UDI-PI type (e.g. expiry date, lot number...) for registering a device in Eudamed and the actual UDI-PI of a device involved in serious incidents and FSCA.

 

[EmiliaBedelia]

So again, this goes back to how you actually control your production. I totally see your point about having an expiry date for product control purposes - however, the upper level package would still have its own PI, which you can determine however you want (including taking it from the lower level PI). Realistically, if you have a case that contains product with expiry dates of Oct 1 and Oct 5, the expiry date for the entire box is Oct 1. Your warehouse team wouldn't say "eh, it's October 2 but part of the box is usable so we'll ship it anyway", right?

Therefore the PI for the upper level box might be based on the lower level package PI, but it still has its own distinct PI. Once you've declared that case to be a trade item, it is now considered as "one item" and therefore it can't have multiple identifiers associated to it. That is why I am confused about putting 2 UDI barcodes on 1 package - each trade item needs its own UDI.

My overall point here is that this is probably not a new question. Presumably mixing lots and expiry dates is an issue that you have already considered just from a logistical standpoint and you have some solution in your process as to how you would handle it. UDI for MDR is probably not introducing anything new - you just need to codify what your actual production practice is.

 

[Cybel]

Your position is interesting, but I'm not sure.
Maybe I'm wrong but if you have 1 case containing products with two different PI, and you label the case in the same way as the content inside, you have direct traceability of both, I don't see contra-indications for this: the person in the warehouse just have to scan both to know the content of the case.