Requirements for marketing collateral translation into local languages in Europe?

J

JonahAJ

I have been told today that a company can only use product brochures that have been translated into the local language for medical devices. Is this true?

In other words, if I sell into Norway, I have to have a Norwegian language brochure. I have never experienced this before. If this is the case then has this always been the case or a recent change?

I have been selling and marketing medical devices since the MDD came into force and have never come across this before.

How would a company handle attending a conference in a European country that is attended by delegates from other European countries?

What about websites and brochures that can be downloaded from them?

Could I ask for comments and advice?

Thanks
 
Ronen E

Ronen E

Problem Solver
Moderator
JonahAJ said:
I have been told today that a company can only use product brochures that have been translated into the local language for medical devices. Is this true?

In other words, if I sell into Norway, I have to have a Norwegian language brochure. I have never experienced this before. If this is the case then has this always been the case or a recent change?

I have been selling and marketing medical devices since the MDD came into force and have never come across this before.

How would a company handle attending a conference in a European country that is attended by delegates from other European countries?

What about websites and brochures that can be downloaded from them?

Could I ask for comments and advice?

Thanks
Click to expand...

Hello,

Under the MDD, member states are authorised to require that the "information required to be made available to the user" (consult Essential Requirement 13, MDD annex I) be provided in an official language of theirs; and in fact it seems that most member state do require so. I undersatnd that this provision relates to devices placed on the market in the member state. I'm not sure regarding the conference attendance.

Cheers,
Ronen.
 
J

JonahAJ

Thanks Ronen. I was under the impression that Essential Requirement 13 related to manuals and product documentation rather than marketing brochures. So this is incorrect and it should include brochures as well. If so there are many, many companies not observing this including some very big ones.

J
 
A

Alexisss

Hi there
you will not be placing a product in the market, therefore there is not something related to the MDD that should bother you.
The only thing is whether the Norwegians have a special requirement for brochures to be printed in Nowrwegian when used in Norway.
Thanks
a
 
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