Hi there,
I've got the same issue as you have it right now, and I received this guidance from EUDAMED support.
"At this moment, the UDI/Device module can be used on a voluntary basis to register in advance the devices. However, as regards legacy devices (devices certified under MDD), there is no need to register them at this stage, especially if they will be certified under MDR in advance of the transition period expiration. You will directly register the device that is MDR compliant.
The only 2 cases where a legacy device should be registered in Eudamed in advance are the following:
- In case the legacy will not be certified under MDR (no Regulation device equivalent), by the end of the abovementioned transition period;
- If a vigilance issue arises.
Regarding the device registration links in EUDAMED, I assume that you cannot see the upload button because your user has minimal/basic rights i.e. viewer.
In order to be able to register devices you will need to request to upgrade your profile in the UDI/Device module to Proposer (who can enter but cannot submit) or Confirmer (who can enter and submit).
To upgrade your profile please follow these steps:
Upgrade your profile
- Log-inEUDAMED with your user click on your name in the top right hand side to reach the My Account page. There you will see a link, next to your profiles, called "Request for change". Click on this link and follow the steps to select the profiles for the module you need. Please do not set an end date for your user.
- Another LAA user will need to approve your request.
IMPORTANT NOTE: it is good practice to have at least two LAAs (Local Actor Administrators) for each actor in EUDAMED because all user requests must be approved by another LAA user. LAA cannot approve its own requests.
So, in case you have only one LAA user, please create a new LAA user for your Actor
1. Create a new user on the EU login by clicking on create an account in theEUDAMED login page: https://webgate.ec.europa.eu/cas/login . It is better that this new user is another person from your company.
2. With the new user from step 1, access
EUDAMED and request access to your actor, via the "NEW ACCESS REQUEST" button and completing your company SRN/Actor ID on the subsequent page. Please make sure this person selects Local Actor Administrator profile and does not set an end date for the user.
3. Log-in
EUDAMED with your existing user and approve the user request from step 2. You will find the request in the user management section of your
EUDAMED homepage.
4. This newly created user will need to approve your profile upgrade request from the user management section".
I hope this guide will help you to register your legacy device(s).
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Dragan Jovic
Nis
Serbia
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Original Message:
Sent: 13-Dec-2022 02:17
From: Anonymous Member
Subject: EUDAMED device/UDI-DI module
This message was posted by a user wishing to remain anonymous
Hello,
can a legacy device class IIa or IIb can be register in device/UDI-DI module?
I understand that the registration in the EUDAMED will be obligatory when the system is fully functioning, however, I would like to register it in the trail period, but I don't see such possibility.
Thank you.