EU MDR language-Translation requiremens

MDRexpert

Involved In Discussions
#1
Hi Everyone,

Can someone confirm that if it is a requirement to have your IFU in all 24 languages? Can we release the IFU only in languages of member states where the product is being sold? Is there a specific EU MDR requirement around this?

"Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient."

It doesn't say that the device needs to be translated in all 24 languages? Is there a guidance or whitepaper released explaining this?
 
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JP12345

Starting to get Involved
#3
Hello, a follow on question from this, how do we find which 'official Union language(s)' are accepted by the individual member states? is this documented somewhere? Thank you for any insight!
 
#4
The European Union has 23 official languages:

Bulgarian, Czech, Danish, Dutch, English, Estonian, Finish, French, German, Greek, Hungarian, Irish*, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenia, Slovene, Spanish and Swedish.

*I highly doubt that anyone in Ireland would want an Irish version.

Also don't forget the European Economic Area Members as well: Iceland, Liechtenstein and Norway
 

JP12345

Starting to get Involved
#5
The European Union has 23 official languages:

Bulgarian, Czech, Danish, Dutch, English, Estonian, Finish, French, German, Greek, Hungarian, Irish*, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenia, Slovene, Spanish and Swedish.

*I highly doubt that anyone in Ireland would want an Irish version.

Also don't forget the European Economic Area Members as well: Iceland, Liechtenstein and Norway
Thank you for your quick reply! I was wondering though, whether there are countries that accept English (for example) as an official union language and therefore that would save us having to translate in to so many different languages? Is there a list of languages that are acceptable in each member state? Eg. using your Ireland example, I imagine English is accepted as an official language there (as well as Irish!) Thanks
 

JP12345

Starting to get Involved
#8
Also, can anyone share any experience of how they have dealt with a product that does not have an IFU (simple class I for example)? I'm struggling to see how we can fit in so many translations of the information on the label!
 
#9
It sounds like you need an IFU but not need to print them in all languages, just make an eIFU - don't forget to follow COMMISSION REGULATION (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices

If your label becomes unreadable that will be a problem
 
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