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Adding the Notified Body Number

K

KAPL61

Registered
#1
#1
If our devices are currently certified under MDD and we are transitioning to MDR is it OK to start adding the NB number to my devices and labels in advance of MDR certification?
We have a project underway to update our labels, literature and direct part marking, etc. and it would double the project size if we have to go back through all of this after MDR certification just to add the NB number.

Internally we are struggling to find a regulatory reference on this. Is there something we are overlooking?
 
QMS for Medical Device Companies
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B

Benjamin Weber

Trusted Information Resource
#2
#2
Without an active certification by a NB, you are not allowed to use the NB number.
Is a NB involved today? So you have a current certification to MDD? From your question I assume not. If the NB will be needed due to classification changes in MDR, you will be allowed to use the NB number only, when you are succesfully certified! Mit before! Of course you can develop corresponding layouts of the Labels in advance. But so not bring them into market without NB certification.
 
LukasLosigkeit

LukasLosigkeit

Starting to get Involved
#3
#3
KAPL61 said:
If our devices are currently certified under MDD and we are transitioning to MDR is it OK to start adding the NB number to my devices and labels in advance of MDR certification?
We have a project underway to update our labels, literature and direct part marking, etc. and it would double the project size if we have to go back through all of this after MDR certification just to add the NB number.

Internally we are struggling to find a regulatory reference on this. Is there something we are overlooking?
Click to expand...

What happens to the products on which you affix the NB number in advance?

Are you already placing these products on the market or are you planning to do so?
 
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