IVDR Clinical Performance

AnnaSokolowska

Registered
Dear All,

I'm preparing Clinical Performance Report for a IVDD-CE medical device, for IVDR application. This is class C device - blood glcose monitoring system for home- and professional use.
I'm wondering if it is necessary to conduct clinical performance studies, while we have system accuracy report conducted for IVDD-CE application and peer-revieved literature analysis of similar devices. We conducted also all necessary analytical performance studies. The system accuracy study was conducted in hospitals outside the EU. The study do not follow ISO 20916.
Do you think that the two sources would be enough to demonstrate clinical performance of our device, or conducting clinical performance studies is necessary?

Thank you in advance!
 
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