If a device (which has its own 510(k) clearance) is always provided as a part of a kit ( which is also 510(k) cleared) , now needs to be provided separately ( for a certain period), does it need to have its independent IFU or can it include the kit IFU ?
Also the Kit is CE marked which involved Notified body assessment , would this individual device need to /can be CE marked similar to the Kit CE marking? Does the notified body need to be informed ?
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
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