Technical File (STED) labelling - When you compile tech files do we have to include all the product labels?

[MDRexpert]

Hi Everyone,
I was wondering when you compile tech files do we have to include all the product labels?
How do you define representative product labels? Thanks!

 

[RobertvanBoxtel]

I assume you mean for CE marking / EU market access?
Yes you do in (probably) all different regulatory regions around the world.

All labels and IFUs (labelling) should be included or referenced in the technical documentation.

Regarding representative label, that's difficult to say.

 

[yodon]

I've seen label drawings / artwork used in submissions. Don't recall this ever being an issue.