Notified body for IVDR - which one?

rosemag

Registered
Hello everyone!
As a manufacturer of IVDR devices, we are selecting notified body we want to work with.
There are 8 notified bodies in Europe for IVDR.

Can you share any experience you have by cooperating with any of them? Or have you heard/read anything about any of them? Do you have any practice suggestions?
I have searched the forum, but there is no information beside huge delay they all have because of lockdown.

Every opinion will be very valuable.
Thanks in advance!
Rose
 

twanmul

Involved In Discussions
The NB's I have experience of are not yet designated under IVDR, so can't give you any first hand experience but I've read good things about DEKRA and TUV SUD. I've seen some guidance/information they have both published which has always been helpful and accurate.
 

planB

Super Moderator
When delay is one of your main concerns, you might have a look at the newest IVDR NB, namely QMD Services ((broken link removed) on their web site). They are brand-new, which might be also their biggest draw-back, since they have no prior experience as a NB, but they might be eager to built a customer base.
 
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