Changes to medical device submitted through a variation?

#1
Is it a requirement to provide a new EU certificate of conformity/notified body opinion if there are changes to the device submitted through a variation?
 
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#2
It depends on what the change is. If it a substantial change that required approval by the notified body, usually a revised certificate is issued, with the revision history explaining what the substantial was. If the change was only a notification, then a revised certificates is not issued.
 
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