Hello,
I hope you can help me out..
We are a distributor of medical devices and are repacking some of them;
for example; we receive 3 boxes of 10pcs from 3 different suppliers. for kitting purposes we open all 3 boxes and make 10 kits.
Now the question; should we provide 3 IFU's in the kit and are we seen as manufacturer in this case?
Should we label the primair package with an label according MDR chapter 3, article 23?
The MDR states in article 16.2b that we can repack in order to market the devices as long we inform our customers the actions we took so we don't think we
Thanks in advance!
Stevan
I hope you can help me out..
We are a distributor of medical devices and are repacking some of them;
for example; we receive 3 boxes of 10pcs from 3 different suppliers. for kitting purposes we open all 3 boxes and make 10 kits.
Now the question; should we provide 3 IFU's in the kit and are we seen as manufacturer in this case?
Should we label the primair package with an label according MDR chapter 3, article 23?
The MDR states in article 16.2b that we can repack in order to market the devices as long we inform our customers the actions we took so we don't think we
Thanks in advance!
Stevan