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Software as a medical device vs software not sold as medical device: local regulations for sale?

#1
Hello!

I was made aware that some countries in the EU have specific requirements for software being sold on their market in terms of language.
I have one software that is marked as medical device, and another one which is not. They are both available with a CE-marked class IIa medical device which I want to sell in the EU.

I am having difficulties finding information on the local requirements that pertain to the software language and I was wondering if anyone knew of such requirements? I would welcome information for any country in the EU really. Our software are already available in English, Spanish and Portuguese.

Thanks a lot in advance!

Best,
Quebec
 
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yodon

Staff member
Super Moderator
#4
@shimonv - that was an impressive compilation! Thanks. I noticed that Canada mentions CD/DVD. Have you seen anything about other media types? What about websites, flash drives, content embedded in an application, etc. Neither of my computers now have CD/DVD drives.
 

shimonv

Trusted Information Resource
#5
This compilation is a bit old, but the principles remain the same, I think. I would say CD/DVD and flash drives are equivalent. User interface (embedded or not) is the same from the user prospective. Websites is a different thing altogether; with websites you need to be careful with marketing / product claim that were not verified or approved.
 
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