Reporting Medical Device Changes with Annex V/VII

shimonv

Trusted Information Resource
#1
Hi everyone,
Which type of changes should be be reported to the NB when the conformity assessment is based on Annex V/VII.

I'am aware of NB-MED guidance document but its not really clear.
Asking the NB directly is always a good approach but better to heave some preliminary intel.

Thanks,
Shimon
 
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