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Medical device registeration in EUDAMED

  • 1.  Medical device registeration in EUDAMED

    Posted 13-Oct-2021 14:38
    Hello everyone,

    We want to register our medical devices in EUDAMED but can not locate this. Can we do this or is this an Authorized Representative or Notified Body activity? Our company is already registered in EUDAMED as a single operator manufacturer and has a SRN.

    Any feedback is greatly appreciated,
    Thanks.



    ------------------------------
    FATEME FARMAD
    Quality and Regulatory Affairs Associate
    Minnetonka MN
    United States
    ------------------------------


  • 2.  RE: Medical device registeration in EUDAMED

    Posted 13-Oct-2021 15:16
    Edited by Kevin Randall 13-Oct-2021 15:16
    The UDI/Device Registration module is not yet available.  Only the Actor Registration module is currently available.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 3.  RE: Medical device registeration in EUDAMED

    Posted 14-Oct-2021 10:08
    Thank you Maria (in Maria's reply from yesterday to the duplicate post of this) and now also Rania today for being so in the know that not even the Commission's EUDAMED status / state-of-play page has announced this yet!

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 4.  RE: Medical device registeration in EUDAMED

    Posted 15-Oct-2021 16:29
    Edited by Richard Houlihan 15-Oct-2021 16:30
    Kevin,

    The Device module has been live since October 4th. If you need any information please do contact me, I used to run the EUDAMED IT teams for the European Commission.

    Regards,

    Richard Houlihan
    CEO Eudamed.com


    Original Message


  • 5.  RE: Medical device registeration in EUDAMED

    This message was posted by a user wishing to remain anonymous
    Posted 29-Dec-2021 09:22
    This message was posted by a user wishing to remain anonymous

    Hi Richard. Maybe you know the answer to my question.

    In the Actor Identification section of the EUDAMED Actor Registration, it asks for an "Organization Identification Document" to be uploaded. What document is this asking for?

    Thanks!
    Original Message


  • 6.  RE: Medical device registeration in EUDAMED

    Posted 29-Dec-2021 09:32

    Hi Anonymous,

     

    For EUDAMED registration the organisation identification document is not mandatory. Examples of this document can be the document you receive in your country for registering your company, a business registration certificate, something official.

     

    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. 

     

     




    Original Message


  • 7.  RE: Medical device registeration in EUDAMED

    This message was posted by a user wishing to remain anonymous
    Posted 14-Oct-2021 13:23
    This message was posted by a user wishing to remain anonymous

    The UDI registration module is now open. See below text from News on landing page https://webgate.ec.europa.eu/eudamed/landing-page#/ 

    The system is available again and the UDI/Devices and NBs Certificates modules are open. IMPORTANT INFORMATIO FOR THE USERS • The default profile for the new modules is the lowest one, i.e. viewer. • To request to change/upgrade your profile into proposer or confirmer, 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. Your LAA/LUA will need to approve this request before these features will be available. • A LAA cannot approve their own requests so for any actor with only ONE user, a second user with a LUA or LAA profile will be needed to approve any profile upgrade requests
    Original Message


  • 8.  RE: Medical device registeration in EUDAMED

    Posted 14-Oct-2021 14:48

    The device registration module went live earlier this week.  If you have multiple devices to register – bad news, there is no upload capability (I've confirmed with the helpdesk).  There are about 5-6 screens of data to populate for each catalogue number.  I've done one thus far and dreading having to start the rest of our portfolio.

     

    There is a function for M2M communication, so probably more of an option for larger companies, but everyone else should get your fingers limber for a LOT of data entry...

     

    Tina

     

     

    Tina O'Brien

    MS, RAC

    Director, Regulatory Affairs

     

     

     

    p: +64 09 8693035, ext. 214 |  e: tina.obrien@aroabio.com     

    corporate: 64 Richard Pearse Drive, Auckland 2022, New Zealand  

    legal manufacturer: 2 Kingsford Smith Place, Airport Oaks, Auckland 2022 New Zealand

     

                                    

     

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    Original Message


  • 9.  RE: Medical device registeration in EUDAMED

    Posted 15-Oct-2021 16:25
    Edited by Richard Houlihan 15-Oct-2021 16:27
    Tina,

    There are other options other than machine to machine uploads. We provide services for companies to avoid the manual entries in EUDAMED Any more than 20 UDI DI's we would recommend not to enter the data manually. We can help from 20 UDI DI's to 10's of 1000's

    Richard Houlihan
    CEO Eudamed.com



    Original Message


  • 10.  RE: Medical device registeration in EUDAMED

    Posted 14-Oct-2021 10:00
    Hi Fateme,

    They actually just released this for manufacturers to register devices. First, you have to log in to your EUDAMED account and update your account settings. You will have to request a change to your profile account data so that you are a confirmer for UDI/Device. Your LAA for the company has to approve your request. Then you should be able to see the module under the Tasks tab under UDI-DIs/Device - Register a new Basic UDI-DI (unless it is a legacy device. In that case, you would register your legacy device).

    Hope that helps!

    ------------------------------
    Rania deLeon
    QA & RA Manager
    Morton PA
    United States
    ------------------------------

    Original Message


  • 11.  RE: Medical device registeration in EUDAMED

    Posted 18-Oct-2021 02:35
    Hello,

    it is not easy to adapt the permissions
    I requested permission for uploading device information and I am also the LAA, but I can not find where I can approve the request

    Greetings,

    ------------------------------
    Franky Dubois
    QA/RA Manager
    Gent
    Belgium
    ------------------------------

    Original Message


  • 12.  RE: Medical device registeration in EUDAMED

    Posted 18-Oct-2021 02:46

    Dear Frank et al.,

     

    You must have at least two people registered for EUDAMED. It is not the LAA that should be uploading data this should be someone with rights in the Device module. To upload data you need to be a confirmer for the device module.

     

    Best regards,

     

    Richard Houlihan

     

     

     

    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. 

     

     




    Original Message


  • 13.  RE: Medical device registeration in EUDAMED

    Posted 18-Oct-2021 09:43
    Richard,

    Thanks for the helpful information. This is very confusing for us. Who should approve a US-based registered manufacturer to make it a confirmer? Should Authorized Representative approve the LAA? or should the LAA approve someone else in the company to get access to device module? I really appreciate it if you could explain this a little bit.

    Thank you so much.

    ------------------------------
    FATEME FARMAD
    Quality and Regulatory Affairs Associate
    Minnetonka MN
    United States
    ------------------------------

    Original Message


  • 14.  RE: Medical device registeration in EUDAMED

    Posted 18-Oct-2021 09:56
    Edited by Rania deLeon 18-Oct-2021 09:56
    Hi Fateme,

    I am a US-based manufacturer as well. I did not have my Authorized Representative approve the LAA. I believe you need two accounts. We had the one account that registered first. We made this an LAA. Then, I went and created an account, and I used the original account to confirm me as an LAA. After this, I was a viewer not a confirmer. I had to request to be a confirmer. Once I requested this, I had to go back to the original account and accept my request to be a confirmer. Then, all of the information appeared under the Task menu.

    Hope this helps!

    ------------------------------
    Rania deLeon
    QA & RA Manager
    Morton PA
    United States
    ------------------------------

    Original Message


  • 15.  RE: Medical device registeration in EUDAMED

    Posted 18-Oct-2021 11:15

    Hi Fateme,

     

    No problem. First of all, when you register for EUDAMED as a company, the very first registered user is automatically give the LAA role, this is the highest level of rights in EUDAMED. The Authorised Representative validates the manufacturer at company registration time before the Competent Authority validating you. After you receive your SRN the Authorised Rep has no more input into your company registration, they have no involvement in managing you or your uses. Your LAA is the one that validates users.

     

    You require at least two users to enter Device data in EUDAMED. Both can be LAA's but at least one needs the Confirmer profile for devices. To full submit a device you must be a confirmer, however, there is also the proposer profile which means they can simply enter data but not finally submit it to EUDAMED, this is the job of the confirmer.

     

    One last point, if you are uploading XML data via the Bulk Upload option the user must be a confirmer.

     

    If you need any assistance with your XML preparation and data validation please do consider us.

     

    Best regards,

     

    Richard Houlihan

     

     

     

    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. 

     

     




    Original Message


  • 16.  RE: Medical device registeration in EUDAMED

    This message was posted by a user wishing to remain anonymous
    Posted 20-Oct-2021 08:19
    This message was posted by a user wishing to remain anonymous

    Hi Richard,

    Thank you for your helpful responses. 

    • Is the XML bulk upload function currently available on Eudamed? I don't see it in my account and I'm a confirmer. Can you point out where you have to go to upload a XML file?

    • Is it possible to do a hybrid approach, i.e. manual entry (web form) for certain products and XML upload for other products?

    Kind regards,


    Original Message


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