Notified Bodies - ISO 13485 & MDR Technical Files

#1
Hi there,

Please can someone provide some assistance/clarification.

We are a Class IIa medical device company with ISO 13485:2016 and CE marked products. We currently use one notified body for both.

Due to the exorbitant costs quoted recently, we are wanting to move our ISO 13485 (only) from our current NB to a new NB.
We want to still use current NB for Technical File reviews against MDR requirements.
Is is possible to house these under two different bodies?

** I am terrified to broach subject this with our current NB yet as we have not had a good relationship with them during the past year and I am concerned they will flip a noodle an become exceptionally difficult.
 
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#2
It may be semantics but the notified body is the organization that will assess your product/system and will provide you with the right to apply a CE mark.
A certification body will provide you with a certificate for ISO 13485:2016.

You can use a different certification body for ISO 13485:2016 than your current NB.
 
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