Medical Device Packaging Multilingual Labeling

image182

Involved In Discussions
#1
Currently our labeling consists of
  • Packaging with english text and ISO 15223 Symbols
  • IFU with translations in various languages and explanations of the ISO 15223 symbols in their respective languages
Recently we have had requests from our distributors in various EU and other non-EU countries to add translations of device type onto the packaging.
Is it becoming standard practice to include multilingual translations on the packaging as well as in the IFU?
If so, is there any guidance as to what content is expected to be in multilingual format on the packaging?
 
Elsmar Forum Sponsor
#2
I have never been asked to do this and I don't believe the requirement exists.
But if it's doable, why not? At least then you would have a one size fits all.
Although, not sure where it would fit depending on device size.
Usually, if there's no requirement, there's no guidance.

I don't think it's becoming standard practise
 

dr1vn

Involved In Discussions
#3
Currently our labeling consists of
  • Packaging with english text and ISO 15223 Symbols
  • IFU with translations in various languages and explanations of the ISO 15223 symbols in their respective languages
Recently we have had requests from our distributors in various EU and other non-EU countries to add translations of device type onto the packaging.
Is it becoming standard practice to include multilingual translations on the packaging as well as in the IFU?
If so, is there any guidance as to what content is expected to be in multilingual format on the packaging?
We're doing the same... but with the new EU MDR, I'm wondering if this needs to change?
Specifically, there are 24 official languages in the EU.

Assuming you sell into all 24 countries, does your IFU/packaging need to be updated to comply with all 24 official languages?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Assuming you sell into all 24 countries, does your IFU/packaging need to be updated to comply with all 24 official languages?
In principle, every Member State has the right to require that information is provided in each and every one of its official languages, where a device is made available in that State. In practice, not all of them require so. Sometimes just one of the official languages is enough. There's also some overlap between States.

The prudent thing is to study your situation in detail, for each case, including State-specific legislation.
 
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