EU MDR - Change of device name (legacy device)

#1
Class IIb Medical device not yet on the market received CE mark under MDD. Marketing would like now to change the medical device name. What is the path (if any) to change the device name of a legacy device under EU MDR?

Any suggestion, specially from people with direct similar experience after May 26th, 2021 would be greatly appreciated.

In advance, many thanks.
 
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Cybel

Involved In Discussions
#2
MDR is a completely new certification, so no matter whether a device was already registered under the directive and with what name, you can register the device with the new name under MDR. In the technical documentation you may link the new name to the previous one.
 

shimonv

Trusted Information Resource
#3
@DominicDV,
It's best to contact your notified body, explain the situation and see if they can issue a new CE MDD certificate.
Product name change is not a significant change, but they might not be willing to issue any more CE MDD certificate.
 
#4
MDR is a completely new certification, so no matter whether a device was already registered under the directive and with what name, you can register the device with the new name under MDR. In the technical documentation you may link the new name to the previous one.
Hello Cybel: Many thanks for the information.
 
#6
I have similar question. We are a producer of class I medical software, with the declaration of conformity issued before 26th of May 2021. Can we now change the name of the software as a medical device and change the albeling of the product?
Is it posiible to start to use both names in the same time, always with the information that this is the same product?
@DominicDV could you please share the end of the process for your MD?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#7
Follow the guidance document for significant changes for MDR. I cant recall the name NBCG Something.
 
#8
Thank you @Ed Panek but in the guidelines, there is only information, that the name of address of the producer is not a major change. There is no info about the device name change during the grace period between MDD and MDR.

However, they blocked the possibility to release the MDD certificates because of a change of the product name.
Do you feel, that for the device class I we must interpret it similarly, that we shouldn't change the DoC, IFU, labeling even if it is only about the name of the device?

For a class I can not even ask the NB for their opinion :(
 

Raisin picker

Quite Involved in Discussions
#10
No grace period for those
Actually, you have issued a Declaration of Conformity sometime before May 2021. You must not issue a new MDD-DoC, since the basis for this is not available anymore. But your self-declared MDD-CE is still valid thru the grace period.
Regarding not significant changes, I heard that NBs issue amendments to their certificates, but I can't remember the source for this any more. But if you find it, this could be an option for you.
 
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