Language Translation Requirements for Software Interface in EU Countries

J

Jwreeves

#1
Looking for input on translation requirements (language) for EU countries. I am aware that some countries do not require software interface translated even though they require all other labeling translated. Looking for a spreadsheet or overview of what each country requires fro software. Specifically our immediate need is;

Switzerland
France
Germany

Thanks for any input
 
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Stijloor

Staff member
Super Moderator
#2
Looking for input on translation requirements (language) for EU countries. I am aware that some countries do not require software interface translated even though they require all other labeling translated. Looking for a spreadsheet or overview of what each country requires for software. Specifically our immediate need is;

Switzerland
France
Germany

Thanks for any input
Can someone help?

Thank you!!

Stijloor.
 
J

Jwreeves

#4
Thanks for reference to attached docuemnt. I do have that document.

However, my concern is to find actual requires for software interface. I am finding that not all countries that require translation of labeling are requiring translation to software interface.

Software translation is very expensive and we are trying to easy into this as necessary.
 
S

sjd1201

#5
Looking for input on translation requirements (language) for EU countries. I am aware that some countries do not require software interface translated even though they require all other labeling translated. Looking for a spreadsheet or overview of what each country requires fro software. Specifically our immediate need is;

Switzerland
France
Germany

Thanks for any input
I've been a technical writer for enterprise software companies for many years. It has been my experience that there are no national requirements. Instead it depends on your product and target market. Your sales team in these countries will tell you whether it needs to be translated. If they can't sell it in English, they'll let you know REAL fast.

In fact, most companies I've worked in the translation budget belonged to Sales. If they can't sell enough in that language to offset the cost of translation (which is often considerable), the company probably should not be making that investment.

Hope that helps.
 

pkost

Trusted Information Resource
#6
I've been a technical writer for enterprise software companies for many years. It has been my experience that there are no national requirements. Instead it depends on your product and target market. Your sales team in these countries will tell you whether it needs to be translated. If they can't sell it in English, they'll let you know REAL fast.

In fact, most companies I've worked in the translation budget belonged to Sales. If they can't sell enough in that language to offset the cost of translation (which is often considerable), the company probably should not be making that investment.

Hope that helps.
I'm sorry, but this is just wrong with regards to medical devices - the directive allows for individual countries to set language requirements for labels and instructions, software interfaces are included in this. I'm sure that many sales people could sell english language medical software into EU countries, this doesn't make it legal.


With regards to the OP's original question - I'm unaware of any exceptions, although you say you are - I would suggest contacting the appropriate competent authorities and asking them, justify why it shouldn't be necessary and they may listen!
 
S

sjd1201

#7
Yes, I can believe that answer was wrong. I was looking at the last 24hour's posts and didn't notice this one was in the medical devices area. I surely hope they have higher standards than enterprise software.

Apologies for the noise. :)

Sally
 
J

Jwreeves

#9
Thanks for the input. We have started to contact the specific regulatory agencies in each country. This appears to be the best way since GUI falls in that gray area.

We are going to take stance that GUI is labeling and should be translate where labeling translations are required.
 
E

esalsan

#10
Hi, it also depends on the user, i.e., if the software is going to be used directly by the patient or, for example, by a qualified doctor.

Back in 2009 I looked through the individual transposition of the MMD as a national law in France and Germany.

In the case of France the requirement of translation is for medical devices to be used by the patient, there is no specification about professional use (see Articles R5211-12 à R5211-20 (French version)

Full context of French MDD can be found here (in French).

In the case of Germany, they do specify the following, quoted from the attached “German Medical Devices Act.pdf”. Part II, §11 (2):
“Medical devices may only be supplied to users if the information destined for their use is written in the German language. In justified cases, another language which is easily understood by the user of a medical device can be envisaged or provisions can be made to ensure that the user is informed by other means. However, in such a case, the information bearing on safety must be present in German or in the language of the user.”

The german act in German can be found here.

I have no information about Switzerland, I am afraid.

Also attached a document from the European Union (dated 2005). Please, let us know the result of your investigation.
 

Attachments

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A Language Translation Requirements for IVD's on the EU Market ISO 13485:2016 - Medical Device Quality Management Systems 3
P Medical Device Language Translation Requirements EU Medical Device Regulations 9
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