Hello,
Indeed the citation you made Anne does require the information provided to be in the official Member State language. This is quite commonly understood today as there have been instances in the past where products had issues with local regulatory for not being in the local language. Though in my experience, I think some "turn an eye away" when the device is professional use. Though for Over The Counter (OTC) products or lay-person use products (prescribed to take in a private environment) it is quite expected to be in the local language.
To answer your question, unfortunately there is not a central list out there. Some of the language translation companies keep their own lists of current, but I do not think it has changed much. There are some lists out there, which can be checked through individual Member States. As Anne said, some countries have multiple official languages which are recognised. Of course, this goes along with understanding, readability, intended audience, etc. for the IFU or other labelling information.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 31-May-2022 11:50
From: Anne LeBlanc
Subject: IFU languages to market products
Hello Anon
No, I don't think the MDR requires the official languages. Do you have a specific reference for that?
I'm looking at Article 10, point 11 (in the English-language version of the regulation).
"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."
This means each member state gets to decide what languages it requires for what device types. Some require the use of their official state language(s), or the subset of those languages that are also official Union languages. Some allow other unofficial but commonly understood languages.
For example, Finland. The officially recognized languages are Finnish, Swedish, Sami, Romani, Finnish Sign Language and Karelian. However, the Finnish Medicines Agency requires devices to be labeled in Finnish and Swedish in some cases, and in other cases in Finnish or Swedish or English.
https://www.fimea.fi/web/en/medical-devices/operators/distributors/national-language-requirements
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Anne LeBlanc
United States
Original Message:
Sent: 30-May-2022 05:49
From: Anonymous Member
Subject: IFU languages to market products
This message was posted by a user wishing to remain anonymous
As stated in MDR 2017/745, the manufacturer should provide the user manual in all languages of the countries where the medical device can be distributed. What could be a reliable source that identifies the official languages for each European Nation? If a Nation has more than one official language, is it necessary to have the user manual in all languages or is it sufficient to have one of them?
Thanks in advance to those who will help me resolve this doubt.