Hi all,
Just wondering if anybody has any experience or guidance on what the rules are when supplying IFUs/labels to a market outside of the EU? Obviously the IVDD/IVDR states that the labelling must be in the local language within the EU (to paraphrase), but what about countries outside the EU - ie Russia, Serbia, China etc?
Is it still the responsibility of the manufacturer to ensure that the appropriate languages for the target markets are on the labels?
I am assuming we are, but I just wanted to confirm.
Thanks!
Just wondering if anybody has any experience or guidance on what the rules are when supplying IFUs/labels to a market outside of the EU? Obviously the IVDD/IVDR states that the labelling must be in the local language within the EU (to paraphrase), but what about countries outside the EU - ie Russia, Serbia, China etc?
Is it still the responsibility of the manufacturer to ensure that the appropriate languages for the target markets are on the labels?
I am assuming we are, but I just wanted to confirm.
Thanks!