IFU in different language other than English

[Harini17]

Dear Experts,

I want to understand regarding the language of the IFU. Is it necessary to have IFUs in English language? Per new MDR, Annex II, 2.0; page 117 it states "the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold"

in such instances, what is the approach we need to follow to draft CER and how can we use other language IFU (not in English) as a reference?

Appreciate your guidance.

looking forward to hear from you

Many Thanks in advance!

 

[somashekar]

Hi.. You need to decide which are the member states your product is going into and find out two things from that state.
The language requirement for professional users and the language requirement for the layman.
Depending upon your device and use, you can then decide all the language requirements you need to respect.
When you have your English version of the IFU ready and final, you may approach any qualified professional for needed technical translation and compile a common IFU, as a booklet or multi fold card, having all your languages within and use it with the product. Take all care about the symbols used.
For a start, the attachments may help. Please validate. Good Luck

 

[Harini17]

Dear Somasekar,

Thanks for your valuable guidance. Please correct me if my understanding is wrong :

The other language IFU needs to be first translated to English and approved from qualified professional (such as SMEs, RA) regarding the content and then can be used as a reference in the CER.

Kindly suggest.

Many Thanks!

 

[somashekar]

Dear Somasekar,

Thanks for your valuable guidance. Please correct me if my understanding is wrong :

The other language IFU needs to be first translated to English and approved from qualified professional (such as SMEs, RA) regarding the content and then can be used as a reference in the CER.

Kindly suggest.

Many Thanks!

No.
I believe that you have first the English language IFU which is correct, complete and approved.
You then use this as input for all other language translations, vide any language experts for technical literature translation.
You maintain the credentials of the translator to support your translation correctness.
Its very important that you select here such competent translators and such companies who offer these languages services
(I do not get what you mean by CER)

 

[Harini17]

Dear Somasekar,

Thank you for your suggestion. CER - clinical evaluation report, for marketing any medical device in the Europe Union (CE mark approval), it's mandatory to have Clinical Evaluation report and the IFU is one of the source docs used as a reference in drafting the CER.

Thank you!

 

[QM_123]

Dear Experts,

I want to understand regarding the language of the IFU. Is it necessary to have IFUs in English language? Per new MDR, Annex II, 2.0; page 117 it states "the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold"

in such instances, what is the approach we need to follow to draft CER and how can we use other language IFU (not in English) as a reference?

Appreciate your guidance.

looking forward to hear from you

Many Thanks in advance!

Hello Harini,

I think English is not necessary, because as you quoted, you must use the language which is accepted in EU member states. However, you must take into account some parameters; first of all your NB's language, i.e if you a French company but your NB is Hungarian so your IFU should be English because most probably your mutual language will be English. On the other hand you have to think about your competent authority, most probably it will demand your official language version. And finally, you have to think about your customers. You know, IFU is important document to properly inform users, therefore it should be understandable totally for users and so IFU should be prepared according to user profile, so if you are a exporter please consider your customers language.

Regarding your question on CER; actually you know whole technical file documents should be prepare same version; I mean language of whole file must be same . But, as Somashekar says, your all versions must be same (word for word). Generally manufacturers prepare IFU as one document which includes all language versions, I suggest you to prepare by this method and finally it will not be important which version is referenced for your IFU, because finally it will include all languages. Please be sure all language versions (translations) are same and again as Somasheakar says it must be translated by a really experienced interpreter who can make technically correct translation. I hope this will be helpful, I know lots of companies all follow this method and until now everything is OK.

 

[Irena22]

Hi.. You need to decide which are the member states your product is going into and find out two things from that state.
The language requirement for professional users and the language requirement for the layman.
Depending upon your device and use, you can then decide all the language requirements you need to respect.
When you have your English version of the IFU ready and final, you may approach any qualified professional for needed technical translation and compile a common IFU, as a booklet or multi fold card, having all your languages within and use it with the product. Take all care about the symbols used.
For a start, the attachments may help. Please validate. Good Luck

Dear Somashekar, dear Experts,
The document MDEG-2008-12 is quite old. Are you aware of any updates?
I doubt that information in this document are still valid... what do you think?
Thanks!