Thanks Richard,
Definately we will be in touch with you in future.
As you said we have two user and out of them one is PRRC.
So after login from both the ID we are not able to register.
But again we will try as per the Eudamed guide.
Thanks
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AP
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Original Message:
Sent: 25-Jan-2022 12:53
From: Richard Houlihan
Subject: UDI devices registration in EUDAMED
Hi Amita,
If you are registered for EUDAMED, and you have two users, one of whom needs a Device module role, then you can add devices. Nothing is blocking any company from adding their devices just now.
Our clients have uploaded thousands of devices so far. You do need at least two users registered to add devices. For sure you can add devices just now once you have the correct users set up. You can always try our training sessions where we explain exactly what is required.
EUDAMED Production is here: https://webgate.ec.europa.eu/eudamed/landing-page#/
Best regards, Richard Houlihan | 
@eudamed.com |
|
EirMed Ltd |
Brussels, Belgium | Sofia, Bulgaria |
t: +359 2 492 8458 |
|
e: richard.houlihan@eudamed.com |
|
EudaMed.com | |
|
The content of this email is confidential and intended for the recipient specified in the message only. It is strictly forbidden to share any part of this message with any third party, without the written consent of the sender. If you received this message by mistake, please reply to this message and follow with its deletion, so that we can ensure such a mistake does not occur in the future. |
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Original Message:
Sent: 1/25/2022 12:30:00 PM
From: Amita Pandey
Subject: RE: UDI devices registration in EUDAMED
Thanks Richard Thanks for your input.
Yes there are many requirements during registration for UDI as mentione below.
Name Trade Name Applicable Regulations Risk Class Nomenclature Code Reference/Catalogue Number Country Scope MF/PR Actor Id/SRN MF/PR Name AR Actor Id/SRN AR Name
But as my previous post the doesnot allow to register the UDI devices , and as per the GUIDELINE for Eudamed also not displaying for registration.
We will keep on checking for this.
Thanks
------------------------------
AP
Original Message:
Sent: 25-Jan-2022 12:11
From: Richard Houlihan
Subject: UDI devices registration in EUDAMED
Hi Amita,
Yes, the European Commission (EC) EUDAMED is not mandatory at present however there is anecdotal evidence of Importers and Distributors requesting companies to put their data in there. So while the EC are not requiring EUDAMED to be populated just now the market is beginning to request it. For me, I would strongly advise all companies to get their data in as soon as possible, it has to be entered anyway so why wait and have a stressful project. EUDAMED requires a lot of data with a lot of rules, far more than the FDA, don't underestimate the work involved.
You are correct the UDI DI is the barcode and of course, the human-readable UDI DI is also required.
Best regards, Richard Houlihan | 
@eudamed.com |
|
EirMed Ltd |
Brussels, Belgium | Sofia, Bulgaria |
t: +359 2 492 8458 |
|
e: richard.houlihan@eudamed.com |
|
EudaMed.com | |
|
The content of this email is confidential and intended for the recipient specified in the message only. It is strictly forbidden to share any part of this message with any third party, without the written consent of the sender. If you received this message by mistake, please reply to this message and follow with its deletion, so that we can ensure such a mistake does not occur in the future. |
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Original Message:
Sent: 1/25/2022 11:17:00 AM
From: Amita Pandey
Subject: RE: UDI devices registration in EUDAMED
Thank you sir,
As I am also getting the message that
"The European Commission is not in a position to require the use of the UDI/Devices registration module until EUDAMED is fully functional according to the Medical Device Regulation. Therefore, additional national requirements on registrations cannot be excluded."
Here is the link for accessing the site.
https://ec.europa.eu/health/md_eudamed/ududi_devices_registration_en
As the basic UDI is being generated for different products as per generic name but as there are many variants in a particular device ,like changes in length ,Dia or different brand names etc.
But as I think the Barcode is the UDI which we print on labels.as this is also unique number alloted for different variants.
So I hope that that will be considerable.
------------------------------
AP
Original Message:
Sent: 25-Jan-2022 03:34
From: Richard Vincins
Subject: UDI devices registration in EUDAMED
Amita,
There are a couple modules which can be used in EUDAMED on a voluntary basis. It would be good to start using the system now to get used to the interface and content. The overall EUDAMED system has been communicated will be fully functional sometime late 2023 or 2024 so it is not compulsory yet.
------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 25-Jan-2022 03:09
From: Richard Houlihan
Subject: UDI devices registration in EUDAMED
Hi Amita,
You can register devices in EUDAMED since October 4th 2021. If you need any assistance with the registrations please do contact us.
Best regards, Richard Houlihan | 
@eudamed.com |
|
EirMed Ltd |
Brussels, Belgium | Sofia, Bulgaria |
t: +359 2 492 8458 |
|
e: richard.houlihan@eudamed.com |
|
EudaMed.com | |
|
The content of this email is confidential and intended for the recipient specified in the message only. It is strictly forbidden to share any part of this message with any third party, without the written consent of the sender. If you received this message by mistake, please reply to this message and follow with its deletion, so that we can ensure such a mistake does not occur in the future. |
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Original Message:
Sent: 1/24/2022 12:28:00 PM
From: Amita Pandey
Subject: UDI devices registration in EUDAMED
Hello all,
When We can register the UDI in EUDAMED.
As the site showing registration of UDI devices is not operational.
.