Medical Device News EU MDR – Information on stages in designation process from Team-NB

Marcelo Antunes

Addicted to standards
Staff member
Admin

yodon

Staff member
Super Moderator
#2
Am I reading this right... there's only going to be ~20 NBs designated for MDR?

There's currently 54 designated for MDD ... and they're struggling to keep pace?
 

Rincewind

Starting to get Involved
#3
Am I reading this right... there's only going to be ~20 NBs designated for MDR?

There's currently 54 designated for MDD ... and they're struggling to keep pace?
Not necessarily, not all NBs are a member of Team-NB, of the 24 members so far 20 are on their way to MDR accreditation.

But yeah, the outlook is grim.
 
Last edited:

Edward Reesor

Involved In Discussions
#5
Is there any information on the number of companies or the products they manufacture withdrawing from the EU market as a result of these changes? In Canada, the mandatory MDSAP (significantly smaller market) has resulted in many companies withdrawing.
 

yodon

Staff member
Super Moderator
#6
Whatever the number might be now, I expect it will rise dramatically after the MDR and (especially) the IVDR kick in. The IVDR will up-classify many products and it's likely manufacturers won't / can't take on the burden for such legacy products.
 

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