Requirements for delivery into several sales countries


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I was wondering about the requirements to extend the sales countries of a medical device. What needs to be fullfilled for adding another EU country to the sales countries? Is it just informing the NB about it and putting a label with the relevant language incl. a national contact person/distributer (done in a proper translation procedure) on the product? Is this all or did I miss something? That I will need to include these country in my PMS is clear, also that there can be possibly national special requirements (e.g. other limits in product Use) that needs to be taken into account is clear too. But is this all? I just feel, that I have overlooked something..... In the past, I had registered the product within the national authorities, but the ones I asked, told me this is not needed anymore and notifying the NB was stated to be sufficient.

I am curious about your ideas.

Thanks a lot for your help :)


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I believe some member states have national registration requirements. Several member states identify an official language and the IFU will need to be translated. I don't believe the NB would consider this to be a significant change.


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Thank you, that means, despite the IFU, which i inluded in the labelling, that's it and thus very simple :)
I hardly couldn't believe that this can be that easy.
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