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Device CE certified under MDD / MDR > new GTIN?

MedicalDevice123

Regulatory affairs specialist
#1
Hi, thank you for the valuable information on this forum!

The question is; are new GTIN's neccessary for the UDI if we have the devices certified under MDR?
There will be small differences in IFU and labels, but the device and CEmark will stay the same. Through change control documentation we can separate the devices based on their LOT-numbers. Changing all GTIN's will a have lot of impact on logistics and device registrations.

Thank you for your feedback!
 
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kreid

Involved In Discussions
#2
Not a direct answer to your question, but:
You do have to have UDI on an MDD device, UDI is an MDR requirement.
There are instances where you would have to register the MDD device on Eudamed but assuming you have no vigilance issues you will not have to register the device.
 

RA_QA_Expert

Involved In Discussions
#4
Yes, you can use your current GTIN´s as UDI-DI acc.to MDR.
If you already use GTIN/DI for example for USA, UAE,..., the core requirements relating to DI/UDI-DI are still the same (worldwide). But do not forget Basic UDI-DI, this identifier is unique for EU.
 

kreid

Involved In Discussions
#6
IS EUDAMED test environment available already for use? Thanks
Yes, people/companies are able to get access to a test version. Not sure how to do it, but it is up and running. I think comments need to be submitted by the end of this month (Sept 2019)
 

duinyk

Involved In Discussions
#7
Yes, people/companies are able to get access to a test version. Not sure how to do it, but it is up and running. I think comments need to be submitted by the end of this month (Sept 2019)
Thanks so, you have no idea how I can access this test environment?
 
#8
Hi,

An internal guidance document from MedTech Europe confirms that you can re-use the GTIN/DI for MDR - assuming the device is identical.

BR
J
Hello Joseph, can you help me to find the mentioned internal guidance document from MEdTech . THank you so much.
 
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