UDI-DI and level of packaging

[TomQA]

Hello,

I have a quick question for which I can't seem to find the answer.
In our case we have a reusable class IIa electrical medical device which is packaged into one box (one level of packaging). there are no other level of packaging.
The device has its own UDI-DI ("UDI-DI 1") and the packaging should also have a UDI-DI ("UDI-DI 2") as the UDI-DI is "required for every level of packaging".
My question is : Should the UDI-DI 2 be different than the UDI-DI 1 although there is only one unit inside the packaging ?
I would completely understand if there were many devices in one Packaging unit (UDI-DI 2 would be different to UDI-DI 1) but in our case where we have only 1 device in one packaging unit (so 1:1), I seem to be confused.
I hope that I am clear.
(PS, if you could give also the "source"/requirement for your answer that would be great ! )
Thank you so much.

 

[yodon]

The ONLY thing in the outer box is the inner box (containing the device)? No IFU or anything else? Is the outer box just a shipping container?

 

[TomQA]

The ONLY thing in the outer box is the inner box (containing the device)? No IFU or anything else? Is the outer box just a shipping container?

No there is only one box (black square) which has the device in red!

 

[yodon]

Ah, my apologies, after re-reading, I see that now. I do believe that the UDI-DI will be different and will indicate a packaging level. My understanding (and certainly don't take this as gospel) is that your UDI DIs will be 0 + 10-digit company prefix + pkg level + a number (0 .. 9 if you bought a block of 10) + a check digit (the services have a calculator to get this one).

Again, that's just been my experience with a couple of projects and getting feedback from actual experts has been challenging.

 

[Cybel]

According to my experience, the device and its single packaging (1:1) should have the same UDI as per article 3.1, Annex VI, part C of MDR:

3.1. A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging shall have their own UDI.

In fact, the single packaging (the box where you punt 1 device) is not a "higher level of packaging", it is the same first level (1:1). I struggled to find some guidances where it is more clear, but I wasn't able to find anything.
The only sign that my interpretation may be correct is that, as per article 4.12, Annex VI, part C:

4.12, If the UDI carrier is readily readable or, in the case of AIDC, scannable, through the device's packaging, the placing of the UDI carrier on the packaging shall not be required.
This may suggest that the UDI on the single packaging is not different from the UDI on the device, otherwise why that should be allowed?

In my company, in most of the cases we are in the situation at #4.12; in the few cases where the UDI carrier is not readily readable through the device's packaging, we place on its singe box a sticker with the same UDI as it is marked on the product. I cannot think to any good reason why it is different.
Then, if my single unit is packaged in a multiple unit box (second packaging level), I apply on this multiple box a different UDI.

 

[Cybel]

I recently attended a webinar about GS1 standard for UDI, with GS1 and I asked that question. They confirm that one device packaged into one box is considered "the device itself", and that its single box is not another packaging level. So the UDI on the device and on its single packaging can be the same.

I asked them this question also referring to this FAQ from the European Commission website
UDI assignment
Q: When the packaging contains only one device and is distributed solely in this configuration to the intended user (patient), can the UDI (DI + PI) on the reusable device and its packaging be different or should it be the same one?
A: Each level of packaging must have a distinctly different UDI.

where, as per my understanding, the answer is not answering the question.
GS1 confirmed that each level of packaging must have a distinctly different UDI but that the single box is NOT a level of packaging.

Hope it helps.