Does your notified body still follow NBOG 2014-3 for MDR legacy devices or only MDR article 120 and Annex VII 4.9?

Osho030

Registered
The current MDCG 2020-3 rev 1 does not mention NBOG 2014-3 at all or lets say anymore, since an initial version had a reference to nbog 2014-3.

So my main question is: Does your notified body still follow NBOG 2014-3 for MDR legacy devices or only MDR article 120 and Annex VII 4.9?
Which means they request you to inform them about such changes for legacy devices (MDD certified).

my second question is: what would be the legal basis for using NBOG 2014-3 since MDR replaced MDD and has no reference to NBOG 2014-3 for product/process changes.
 
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