UDI-DI does it always have to use the manufacturers GTIN?

JP12345

Involved In Discussions
Hello, we are manufacturing a class I product under private label for our customer (we are the legal manufacturer on the label and we hold the medical device file but it is their branding, they are identified as the distributor on the label) and they are insisting that we use their UDI-DI on the product containing a GTIN which identifies their company. From my understanding the GTIN should identify the legal manufacturer and that we should assign the UDI-DI and register it in EUDAMED. I wondered if anybody else had experience in this situation? Thank you
 

Billy Milly

Quite Involved in Discussions
Since you mentioned GTIN, I assume you use GS1 (I am not familiar with requirements form other providers).
According to GS1's labelling standards, GTIN (covering the UDI requirement) should be provided by the brand owner. From MDR perspective, legal manufacturer is responsible to assign the UDI (and respect the chosen labelling standards). So, if you assign the customer's GTIN, you fulfill both requirements. You assigned, brand is not yours.
That is my understanding and my approach. Of course we were not able to convince every customer to provide "their" GTINs - in those cases, we applied ours and clearly informed them that, according to GS1 standards, they no longer "hold" the brand name.
bUDI (GMN) is of course yours in all cases.
 

Cybel

Involved In Discussions
Hello, we are manufacturing a class I product under private label for our customer (we are the legal manufacturer on the label and we hold the medical device file but it is their branding, they are identified as the distributor on the label) and they are insisting that we use their UDI-DI on the product containing a GTIN which identifies their company. From my understanding the GTIN should identify the legal manufacturer and that we should assign the UDI-DI and register it in EUDAMED. I wondered if anybody else had experience in this situation? Thank you

Hi, I have the identical experience. We are manufacturer and we assign GTIN and UDI to our products. When a customer wants to use their GTIN, there is a problem because:
- the UDI must be issued by the manufacturer
- the UDI is based on the GTIN number assigned to the manufacturer by GS1.
- if the GTIN belongs to the customer/distributor, the manufacturer should assign another UDI based on his GTIN, but actually this is not possible because the UDI and the GTIN shall be the same (UDI will be: zero+GTIN).

I've contacted GS1 on this matter and they suggested to add, in the QTA we sign with customers/distributors, a specific clause stating that:
- the manufacturer agrees to create the UDI using the GTIN of the distributor, if the distributor needs to assign his own GTIN (for example because of logistic purpose).
- the distributor recognises that the manufacturer is responsible for assigning the UDI but he "allows" the manufacturer to create the UDI based on the distributor’s GTIN

Of course, I really prefer to avoid this situation.

To clarify, in my case the customers' brand is registered in our CE certificate, so we are in the condition described in MDR art. 16, 1 a): ...except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation.

Since you mentioned GTIN, I assume you use GS1 (I am not familiar with requirements form other providers).
According to GS1's labelling standards, GTIN (covering the UDI requirement) should be provided by the brand owner. From MDR perspective, legal manufacturer is responsible to assign the UDI (and respect the chosen labelling standards). So, if you assign the customer's GTIN, you fulfill both requirements. You assigned, brand is not yours.
That is my understanding and my approach. Of course we were not able to convince every customer to provide "their" GTINs - in those cases, we applied ours and clearly informed them that, according to GS1 standards, they no longer "hold" the brand name.
bUDI (GMN) is of course yours in all cases.

If you refer to the cases where the customer owns the brand and is subject to requirements in art. 16, I agree with you.
 

Billy Milly

Quite Involved in Discussions
- the UDI must be issued by the manufacturer
Assigned. In compliance with issuing entity's standards.

I was specifically referring to art. 16, 1a. Customer owns the brand, manufacturer is responsible for compliance and is labelled as such, this is covered by an agreement. I was not referring to OEM/OBL scenario (whole art. 16), that's another story.
Art. 27 and and Annex VI only state that manufacturer has to assign the UDI. There is no requirement it should be "theirs". Respecting GS1's standards, assigned UDI should be brand owner's.
 

Cybel

Involved In Discussions
Art. 27 and and Annex VI only state that manufacturer has to assign the UDI. There is no requirement it should be "theirs".
So, do you mean that MDR already foresees that the manufacturer can assign to a product (marketed under the customer's brand) the customer's UDI (the UDI based on the GTIN number assigned by GS1 to his customer/the brand owner)?
Assigned. In compliance with issuing entity's standards.
thanks for the correction!
 

Billy Milly

Quite Involved in Discussions
I dived deep into this when setting up our UDI system. We also had an onsite training/discussion with GS1 and during discussion, they stressed that GTIN holder = brand owner. At first, I was also confused on how to solve this, but after reading the UDI requirements in MDR, I came to such conclusion. I wouldn't say MDR foresees this, more like "does not forbid". :)
 

JP12345

Involved In Discussions
@Billy Milly @Cybel Thank you both for your information and shared experiences you have really helped. I will contact GS1 also and confirm with them also that we (as manufacturer) can assign the brand holder GTIN when creating the UDI-DI. Have either of you already registered the UDI-DI of these products in EUDAMED using the brand holder/distributor GTIN with no problems?
 

Billy Milly

Quite Involved in Discussions
Me neither, not yet. I reviewed Eudamed specifications and submission guide and found no restrictions for this scenario so far.
 
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