UDI-DI for device components - configurable device

[SteTop]

Hi all,

is UDI-Di mandatory for components of configurable device?
According to EU MDR one UDI-Di can cover all groups of configurations, according to GS1 allocation rules there is or each one configuration - separate UDI-DI, or to assign GTIN to all base components.
Is there any possibility to follow only MDR although GS1 is our GTIN issung agency?
Does GS1 or FDA ever chech (inspect) GTIN designation?

Thank you.

 

[Billy Milly]

See option 2.
To comply with MDR, you need to comply to GS1 allocating rules, if using GS1. EB already explained that.

 

[SteTop]

Many thanks for provided interpretations. Very helpful.
Thing which bother me is that MDR said following:

and that not matching with GS1 at all. Also, this MDR rule is much more flexible than GS1 standard, although standard is not reguatory mandatory but Regulation like MDR is. Seems MDR is much more practicable than GS1 standard in this case.

This is reason I asked could we rely on MDR more then on GS1 allocation rules in this particular case.

 

[Billy Milly]

6.4.2 aligns with Option 2, read slowly.

 

[SteTop]

6.4.2 aligns with Option 2, read slowly.

To some extent. Although according to option 2 you do not need to assign GTIN to every configuration, you must assign to every component. So if you have a lot of base components - a lot of GTINs to be maintained on component level (according to my understanding).

 

[Billy Milly]

Basic componnt has a GTIN and add-ons are tracked by serial numbers, not individual GTINs.