Do User Manuals (Not Device Labeling) HAVE to be in their national languages for these countries? Will English Hardcopy not do?

[Darshan_Shetty]

Italy, Germany, Spain, Netherlands, France, Switzerland, Austria, Romania, Poland, Belgium, Denmark, Sweden, Czech Republic.

I know countries are stricter in Labels that go on the device and require it to be in national language but User Manuals are usually allowed to be in English in many countries. I was hoping that folks here have some experience dealing with this issue and could point me to the national regulations that state translation is mandatory.

 

[shimonv]

Darshan,
You can search for the English translation of each of the national medical device law (e.g. The German act is called Medizinproduktegesetz – MPG) but it would be much easier to contact your local EU Rep. and ask them for a language localisation table.

 

[Ronen E]

Officially, user manuals (=IFU) are labelling. The regulations require that labelling is provided in each Member State in one of the languages officially recognised by that State. Some recognise English and some don't.

Whether this dry requirement is enforced (more or less strictly) in a given State is a separate matter. Hint: Member States are generally low on resources for enforcement where the perceived risks are not high. Mind you, the competition may whistle-blow for commercial gain, in which case the regulators are theoretically obliged to respond (albeit reluctantly / sloppily).

 

[Rincewind]

Hello maybe the file I attached might help you, but it might be outdated.

 

[Darshan_Shetty]

Officially, user manuals (=IFU) are labelling. The regulations require that labelling is provided in each Member State in one of the languages officially recognised by that State. Some recognise English and some don't.

Whether this dry requirement is enforced (more or less strictly) in a given State is a separate matter. Hint: Member States are generally low on resources for enforcement where the perceived risks are not high. Mind you, the competition may whistle-blow for commercial gain, in which case the regulators are theoretically obliged to respond (albeit reluctantly / sloppily).

Wow.. that is interesting. Did this whistle blowing thing happen to someone around you ? Just curious.

 

[Darshan_Shetty]

Hello maybe the file I attached might help you, but it might be outdated.

Thanks Rincewind! This is helpful

 

[Ronen E]

Wow.. that is interesting. Did this whistle blowing thing happen to someone around you ? Just curious.

I was once indirectly involved as a consultant, on the whistle-blowing side. I pretty much watched from the sidelines (a lawyer handled it) and got a pretty good look of how the regulators handled it.

 

[Asia78]

We have always requests from our distributors in Italy and Spain about manual and product label in Italian and Spanish.
Italian authorities are also often checking randomly the repertorio database and may ask for addiitonal info in italian.
And some years ago we got a minor non conformity by our NB because we gave to customer in Sweden the user guide in English only...

 

[Nigel-S]

I have a similar situation regarding user manuals and would like to run it by you guys.
We are a Class 1 (not 1R,1S,1M) Pilates health exercise equipment manufacturer, located outside the EU and selling product to rehabilitation and physiotherapy clinics across nearly all of Europe (25 countries). Our equipment ships with the Owners Manual written in English only. We also ship with each product a user instructional DVD in English but has language tracks on it for English, French, Spanish, Portuguese, Italian and German.
Would I need to have the Owners Manual translated into every language?
Would it be acceptable to ship the product with the English Owners Manual and have a link stated in the manual to the company website where a translated version of the Owners Manual could be downloaded?
Would the instructional DVD have to be translated for all 25 countries that we sell into?
Cheers, Nigel.

 

[Fredie Krol]

Czech Republic. IFU, labels in Czech language. Requirement of national law.