Class IIb devices marked EC according to the 93/42/CE - Portugal

LAM2020

Starting to get Involved
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
 

cfcruz

Starting to get Involved
Hi Malia,
You need to have the label, IFU and interface in Portuguese (Decreto-Lei n.º 145/2009, article 5, point 6).
 

LAM2020

Starting to get Involved
Hi Malia,
You need to have the label, IFU and interface in Portuguese (Decreto-Lei n.º 145/2009, article 5, point 6).
Hello again,
I did find the law you are referring to but it onlys states that lanel and IFU must be in portugese, it does not say anything about the user interface.
Thank you
 
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