What types of changes need to be notified to NBs?

SGquality

Quite Involved in Discussions
#1
I was wondering if there is a list of type of changes to be notified to the NBs? Also, should these be notified ahead or after the proposed changes?

Thank you in advance
 
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mihzago

Trusted Information Resource
#2
Best to check with the NB as each has their own requirements.
Also, take a look at MDSG 2020-3 and NBOG BPG 2014-3 Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System.
 
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