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.
 
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