Non-EU Language Requirements

#1
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!
 
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Mark Meer

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#2
...Is it still the responsibility of the manufacturer to ensure that the appropriate languages for the target markets are on the labels?...
As you say, it's a safe assumption (usability & safety considerations, and all that...;)), but to know for sure you'd really have to go regulation-by-regulation, as different markets can certainly have their own unique requirements.
For example, Canada requires both national languages (French and English), but only if the device is for sale to the general public. Otherwise, either is ok, provided you can supply the other upon request.
Some emerging markets, I'm pretty sure, have no specific requirements.

For other countries, access to English versions of regulations can be hard to come by, so it may be necessary to inquire through distributor or a regulatory consultant.
 
#3
Cheers Mark, appreciate the response.

All of our IVDs are for professional use only, and I'm *fairly* certain that this changes the landscape slightly in that if it's professional use only then more markets are happy to accept English - would you agree? Obviously depends market by market, and like you said, we will need to determine our target markets and work out the language requirements on a country by country basis - but generally speaking I think (hope) I'm correct.
 

Mark Meer

Trusted Information Resource
#4
...I'm *fairly* certain that this changes the landscape slightly in that if it's professional use only then more markets are happy to accept English - would you agree?....but generally speaking I think (hope) I'm correct.
That's the thing: It's really impossible to make any generalizations.
Certainly you are correct re: professional use in some countries (e.g. Saudi Arabia), but like I say impossible to generalize. You have to go regulation-by-regulation.
 
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