Reporting Medical Device Changes with Annex V/VII

shimonv

Trusted Information Resource
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
 

shimonv

Trusted Information Resource
Okay, I believe I found the answer I was looking for..
The Notified Body Operations group (NBOG) released a detailed guidance on what constitutes a significant change. Attached is the document for your information.


Shimon
 

Attachments

  • NBOG_BPG_2014_3 (Reportable changes).pdf
    306 KB · Views: 184
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