Eudamed UDI-Module

itscloud

Starting to get Involved
#1
Hi,

Just wondering if anyone have finished uploading their UDIs in the new Eudamed module?I'm currently stucked in the process of getting approved for the access.

Who is this second user with a LUA/LAA profile?

1633942737381.png

Thanks a lot :)
 
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ca_moni

Starting to get Involved
#2
You should ask another person in your company to request access as Local Actor Administrator (LAA) or just LUA (Local User Administrator) by creating a new user in the EU Login page and connecting it to your Actor registration. If you are the current LAA, you will receive an email and can approve his access. At that point, you will have two LUA: you may update your profile by asking additional access as "confirmer" in the UDI module, which will be approved by the other LAA/LUA.
 

itscloud

Starting to get Involved
#3
You should ask another person in your company to request access as Local Actor Administrator (LAA) or just LUA (Local User Administrator) by creating a new user in the EU Login page and connecting it to your Actor registration. If you are the current LAA, you will receive an email and can approve his access. At that point, you will have two LUA: you may update your profile by asking additional access as "confirmer" in the UDI module, which will be approved by the other LAA/LUA.
Hi ca_moni,

My manager received the email but did not find the approval link anywhere, I guess I will have to create a new account and try in this way instead. Do you know if there is a deadline for the UDIs info to be uploaded into the module? Thanks
 

debbie gallagher

Starting to get Involved
#4
My understanding is that it is not mandatory until EUDAMED is fully functional, and then there is a grace period, unless you initiate a FSCA or a vigilance report is submitted then it is mandatory. The last expected date I saw for it to be fully functional was mid 2023, but subject to change.
 

Rincewind

Involved In Discussions
#5
My understanding is that it is not mandatory until EUDAMED is fully functional, and then there is a grace period, unless you initiate a FSCA or a vigilance report is submitted then it is mandatory. The last expected date I saw for it to be fully functional was mid 2023, but subject to change.
I read that before and now I struggle to find it, can you point me to the right Guidance? If we have a recall or a FSCA now we need to enter it right now I think.
 

debbie gallagher

Starting to get Involved
#6
We had a lot of debating over this, the MDCG guidance is not the easiest to understand, we eventually reached out to MedTech Europe UDI team asking the question:
  • Once the UDI/Device registration goes live (end of September) is it at that point, that we start the requirement to register a legacy device if a serious incident occurs or a FSCA is initiated? Can you confirm ?
  • Response from MedTech: No based on MDCG 2019-5, upon occurrence of an Incident or a Corrective Action, registration is required upon registration of the Incident or Corrective Action in EUDAMED 6 months after the notice in the European Official Journal per Art. 34.
 

Rincewind

Involved In Discussions
#7
Thank you, I agree that the MDCG Guidances sometimes are causing more confusion than clarity...but does this apply to the functionality of the complete EUDAMED from your point of view or just the required module?
Because I found again where I read it, in an eternal document from a consultant which I can't post here but there it basically says:

If you have a Legacy Device your registration deadlines are:
  1. If you have no incident/FSCA: Latest 24 months after the date of publication of the notice referred to in Article 34(3) if EUDAMED is not fully functional before the date of application of the MDR.
  2. If Incident/FSCA: immediately (under the condition that EUDAMED UDI registration module is available)

So they say only the registration module is needed and then you have to act in case of a FSCA/Recall.

Now I am fully confused.
 

monoj mon

Quite Involved in Discussions
#9
Hi ca_moni,

My manager received the email but did not find the approval link anywhere, I guess I will have to create a new account and try in this way instead. Do you know if there is a deadline for the UDIs info to be uploaded into the module? Thanks
Hello,

You don't need to create a duplicate account. Your manager should first request to be LAA/LUA by clicking on the 'New Access Request'.
1634266794860.png
Once he/she sends the 'Access request' you should receive the notification (check it by clicking the 'bell' button). After that you will need to approve his/her request. Once done, you will need go to your profile setting to 'Request for change' in your 'Account Data'. Once you request the change, your manager will receive the notification in his/her EUMADE LAA/LUA account and he/she shall need to 'approve' it.
 
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