hello we are a french manufacturer of class IIb devioces marked EC according to the 93/42/CE. We have a spanish distributor that distributes our products in spain and we recently found out in Portugal. We did not register our devices in portugal but I believe the distributor can register the medical device in portugal, but for us as a manufacturer do we have to provide the user manual in portugese and the user interface of the medical device ?
Thank you for any advice
Regards
malia
Thank you for any advice
Regards
malia