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Brand owner or manufacturer responsible for Basic UDI-DI and UDI-DI?

#1
Hi,
I find different info online about who is responsible to assign the Basic UDI-DI and UDI-DI. I sometimes see the brandowner and I sometimes see the manufacturer. What is correct? Because I am currently on this position: our company in Belgium holds the brandname, but we let it manufacture in France under our legal entity in France. So the entity in Belgium holds the brandname. The entity in France is mentioned on the label as manufacturer en our entity in Belgium is mentioned on the label as distributor. So which GS1 company prefix do I have to use for making the basic UDI-DI and UDI_DI codes? The one from the Belgium entity (brandowner) or the one from France (manufacturer)?
 
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paris

Registered
#2
There are difference between BASIC UDI-DI and UDI-DI:
Basic UDI-DI is a number for device group such as GMDN or UMDN codes.
but UDI-DI is a number for your product model and it can be GTIN code, which means manufacturer shall provide and assign it.
 

Cybel

Involved In Discussions
#3
According to MDR art. 29, the manufacturer is responsible to assign the basic UDI-DI to its medical devices.

There are difference between BASIC UDI-DI and UDI-DI:
Basic UDI-DI is a number for device group such as GMDN or UMDN codes.
Basic UDI-DI is a number assigned by the manufacturer to one of its specific device group (while GMDN or UMDN are generic: the same GMDN number is used by more manufacturers to identify the same product category to which their product belongs).
Basic UDI-DI appears on relevant documents such as Technical Documentation, CE certificates, DoC, FSC and in Eudamed: these documents are under responsibility of the manufacturer (unless the article 16 of MDR applies)

but UDI-DI is a number for your product model and it can be GTIN code, which means manufacturer shall provide and assign it.
The UDI-DI is assigned for each device and shall be associated with one basic UDI-DI, and it is based on the GTIN code (it may use the GS1 company prefix but it is not the GTIN code).

(Attention: there is some difference with systems or procedure packs).
 
#4
According to MDR art. 29, the manufacturer is responsible to assign the basic UDI-DI to its medical devices.

Basic UDI-DI is a number assigned by the manufacturer to one of its specific device group (while GMDN or UMDN are generic: the same GMDN number is used by more manufacturers to identify the same product category to which their product belongs).
Basic UDI-DI appears on relevant documents such as Technical Documentation, CE certificates, DoC, FSC and in Eudamed: these documents are under responsibility of the manufacturer (unless the article 16 of MDR applies)

The UDI-DI is assigned for each device and shall be associated with one basic UDI-DI, and it is based on the GTIN code (it may use the GS1 company prefix but it is not the GTIN code).

(Attention: there is some difference with systems or procedure packs).
thank you for your explanation, I mean it exactly.
 

duinyk

Involved In Discussions
#6
Hello, is the device module for product upload available in EUDAMED already? They had a date for May 2021 but I cant find anything in there. Just the actor module seems active.

Thanks
 

koulidis

Starting to get Involved
#7
Hello, is the device module for product upload available in EUDAMED already? They had a date for May 2021 but I cant find anything in there. Just the actor module seems active.

Thanks
It is not ready yet. It has been announced that it will be ready at Q4
 
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