Legacy Device UDI Requirements

#1
Hello!

We are working on updating the UDI requirements for a class IIb device. The device is listed as a general device as for the old directive MDD/IVDD. Should one push for legacy device adoption in this case, i.e should we not adopt the new UDI Standards at this moment. Or should we reassess our product conformity to the directives of IVDR/MDR and begin the registration of a Basic UDI-DI for the Eudamed database. Because right now the EUDAMED database does not need a basic UDI-DI for legacy devices.

My question in short, is there some pros/cons regarding legacy devices or is it better to reassess the product, that is not on the market btw, to be compliant with the new directives, in short, give the product UDI information?
 
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mboynton

Starting to get Involved
#2
Hi, I am assuming that, even though your device is not on the market, that you still have it covered under some pre-existing EU MDD certificate from a Notified Body (per EU MDR Article 120(3))? If not, then the legacy device pathway isn't available anyway. That is, perhaps unless you are saying in the first few sentences of your message that there is an up-classification affecting your device btw EU MDD and EU MDR?

Note that while you need to assign a Basic UDI-DI to an EU MDR device internally, you do not actually need to register that Basic UDI-DI in EUDAMED immediately. MDCG 2019-4 gives guidance on the transition period - https://ec.europa.eu/health/system/..._2019_4_devices_registration_eudamed_en_0.pdf

Also, the device does not need to be physically labeled with the UDI until the transition periods in Article 123, 3f and 3g.
 
#3
Hello Thanks for answering!
Yes you are correct with your assumption, in this time we are covered during the pre-existing MDD. I know how to label and such, but what I dont know is if there is any pros/cons by choosing this path. We are at this moment valid for registration as a legacy device. But we can also choose to abandon that part and reclassify it as a new class C device regarding the new IVDR directive. I am wondering if which path er should pursue in this case. If there is some positives by choosing the legacy path or reclassification. The only thing I was able to see, regulatory wise atleast, was the diffrence in UDI classification. Where one does not need it and the other one does.
 

gabe2jadyn

Starting to get Involved
#4
Hi! Does anyone know when we need to register our legacy device in EUDAMED? I have read conflicting information. Also, is labeling part of registration and if so, is it best to wait to register once we get our new EU labels? Thank you -
 
#5
Hi!
I depends if your device is a MDR or IVDR device! The documents states that eudamed has to be “fully functional” which is hard to understand imo. 26 of May 2021 is the date for MDR products and 26 of May 2022 for IVDR products. You will have 18 months to complete this registration after each date. There is no labelling criteria for legacy devices, if your concern is UDI, except the registration of Eudamed DI/ID. You will need your SRN number to generate these numbers. If that’s what you mean by “EU labels”.
 
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