Hello Rashmi,
I am assuming you are referring to the recently published FAQ EUDAMED document for legacy devices. Personally, I have read the document 4 times now and it is still very confusing with introduction of new terms and different ways to handle UDI information. They are making it more confusing than it needs to be. Listing and use of prime numbers ...
Keep in mind, this may only be talking about legacy devices where those devices are not going to transition to EU MDR. If you have a device which is Class I self declare or any device which will be CE Marked under EU MDR they would end up with a Basic UDI-DI and UDI-DI. (Class I self declare need to comply fully by the compliance date.) This also addresses legacy devices through this "transition" period where these legacy devices under MDD/AIMD/IVDD need information within EUDAMED such as reporting serious incidents, registration, and maybe even assignment of UDI. All of this is with the assumption those modules will be implemented in the next couple years.
Again, I do not know why they made this so confusion - would have just been easier to just assign a Basic UDI-DI to everything. Now there is this new designation called a EUDAMED DI. (And I love how they have a EUDAMED DI and a EUDAMED ID - now that is not confusing !) My recommendation is just make it simple, if you are transitioning your products to EU MDR (or EU IVDR) then already assign a Basic UDI-DI and UDI number. If you have products which are not transitioning to EU MDR, don't worry about it?
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 13-Feb-2021 01:24
From: Rashmi Pillay
Subject: Legacy devices and EUDAMED DI
Hi,
As, 'a Basic UDI-DI will never be applicable and never be assigned to a Legacy Device, only EUDAMED DI'. Can anybody clarify , unlike the Basic UDI-DI which is required to be included on the EU DoC, does a EUDAMED DI get mentioned anywhere?
regards,
Rashmi
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Rashmi
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