MDR IFU importer translation

[REGULATED]

Hi, good afternoon,

I would like to receive your view about following approach.

As importers (MDR 2017) of a medical device class IIa we have decided to carry on translation into local language of IFU for a particular manufacturer, but, we want to play a role of a mere translator or linguistic consultant who cooperates with manufacturing company on this ground. Finally this company owns mentioned version and register it where necessary, and manages as needed. Nevertheless is not clear if an authorisation to translate is needed.

Have you got any similar previous experience?

Any suggestion is welcome!

 

[Cybel]

Hi, we are European manufacturer, so we don't have importers but we have distributors. Sometimes, distributors offer to translate IFUs (in this case, we require a declaration of accuracy from their translation agency, which should be certified; otherwise, we ask for a translation review from our translation agency). When this happens, they just provide the translated text and we take care of verification and printing and inserting the IFUs into the medical device packaging. In this case, no authorisation is provided because we, as manufacturer, remain responsible for translations and keep them under control.

But, if you add translated IFUs to the device after you receive it from the manufacturer, it is different and you fall into article 16 of MDR.