EU-countries which don't accept English user manuals and require national translation

[Robin E.]

Hello,

which EU-countries don't accept english user manuals and require national translations?

Thanks in advance.

Robin

 

[Ron Boumans]

In The Netherlands for medical devices we require user information in Dutch. For low to medium risk devices (class I and IIa) it is possible to make an exception. You need to ask the minister for health and in that request you need to make clear that the device is only used by professional users with a higher education that makes it obvious they will understand English.

I expect for other European legislation similar rules are applied in other countries.

For the certification process user information in only one language is often accepted by notified bodies. Of course you need a proper procedure to check translations.

 

[AnaMariaVR2]

I will add to double check with the country's health agency for language regulatory requirements for manuals, minimal languages required, which ones & also, please make sure that you get a certified technical translator experienced on national standards/requirements for this user manual needed. It helps to have a local country contact that can assist you. Ask country's Health Agency to redirect you to the appropriate guidance, or official communication stating language requirements.

 

[Claes Gefvenberg]

Re: EU-countries which don't accept English user manuals and require national transla

As for Sweden, the general requirement is that instructions must be available in Swedish, but no rule without exceptions: For things intended for a limited customer base with special knowledge (advanced technical and/or electronic equipment is mentioned) an English manual may suffice.

However: When it comes to safety, I believe any safety information concerning anything sold in the EU must be available in the language concerned.

/Claes

 

[c.mitch]

Re: EU-countries which don't accept English user manuals and require national transla

For France: the article R.5211-20 of the french public health code requires that the labelling and the instructions for use are written in French.

 

[Angelika Hoess]

Re: EU-countries which don't accept English user manuals and require national transla

For Germany: the information destined for the user must be written in German. In justified cases, another language which is easily understood by the user can be envisaged or provisions can be made to ensure that the user is informed by other means. The information on safety, however, must be present in German.

 

[pkost]

Re: EU-countries which don't accept English user manuals and require national transla

It's better to assume that all countries require their own national language

My matrix of permitted languages says that english can be used in UK, Eire, Malta

Cyprus and Latvia allow it for professional use devices only

My matrix is rather old and could be out of date so I would confirm each country first!

 

[MrsJH]

Re: EU-countries which don't accept English user manuals and require national transla

Please search for:

Language requirements
for EU medical device labels​

Libor Safar, Helen Colquhoun & Cheryl Hill

The article gives you a lot of information on supply of instructions for use, labelling and mandatory languages.
I can't post links
Hope this helps.

 

[MIREGMGR]

Re: EU-countries which don't accept English user manuals and require national transla

Please search for: Language requirements for EU medical device labels (by) Libor Safar, Helen Colquhoun & Cheryl Hill

Here's the link: http://www.cromsource.com/file/201208311127110.Language%20requirements%20for%20EU%20medical%20device%20labels.pdf

Note that this article is from a commercial regulatory service. I have no affiliation, have not used them, and am neither recommending them nor the opposite.

 

[MrsJH]

Re: EU-countries which don't accept English user manuals and require national transla

Here's the link:
Note that this article is from a commercial regulatory service. I have no affiliation, have not used them, and am neither recommending them nor the opposite.

I know it's commercial reg service but thought that document was quite good. It gives a lot of information that can be double cheked elswhere.