Official Language in EU required for Medical Device Labeling

[Tiffany]

Hi mates,

Just find that the official languages in the total 23 languages. As a medical devices manufacturer, need to post all the 23 languages on the product labelling? Any guidelines or documents indicating the minimum type of language required for medical devices labelling?

Tiff

 

[pkost]

To get a definitive answer you will have to look at the specific regulations for each country; however this previous thread has quite a comprehensive list and should be mostly correct

 

[sreenu927]

Hi Tiffany,

A few EU countries accept English labeling, so for those countries no need of translation.
Pls see attached files.

Regards,
Sreenu

 

[CBAL08]

Do we require to follow the translation rules even if the users have never asked for from the following countries? We just had an audit and the were issued a minor NC for not having the Usermanuals in languages other tham English. This is because the devices are used by professionals and customers have never requested us for User manuals in other languages. Do we have to have them in all 23 languages?

 

[Gert Sorensen]

In short: Yes.

The lists above give you a good overview of the requirements.

 

[pkost]

You have to provide the information in the language required by the member state if you market the product in that member state.

If the product is not marketed in that country you do not have to provide it in their required languages

 

[CBAL08]

Thank you for your replies. Well we will have to soon think about this issue.

 

[MPiska]

You have to provide the information in the language required by the member state if you market the product in that member state.

If the product is not marketed in that country you do not have to provide it in their required languages

Whilst this would seem to be true in practise, there is a clause about free sale of CE marked goods and that you cannot restrict the sale.

Just because you don't specifically market a product in a country, they should still have the right to buy it (being CE marked) and therefore have the instructions in the language that they require.

Where I work we supply IFUs in 13 languages and have the labelling in anywhere up to those 13. Most labelling for our products is symbolised and referenced in the IFUs which is an easy way to get around labelling issues.

Fortunately I'm not the one that has to answer the question when we are asked why we don't supply in all 23 languages, however I believe that the answer is "if any country requests their language we will process the translation as a priority for them".

 

[Pads38]

Article 4 paragraph 4. Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use.

So member states can block sales if the labelling is not in the right language.
If they do not it is probably just because that they do not know that such sales are going on.

 

[pkost]

The manufacturer isn't restricting sale by not applying all languages - the entity selling the product into a country without the correct language is within their rights to translate the text into the local language (parallel trade).