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EUDAMED Registration

  • 1.  EUDAMED Registration

    This message was posted by a user wishing to remain anonymous
    Posted 17-Nov-2021 10:47
    This message was posted by a user wishing to remain anonymous

    Hi,

    Can anyone provide guidance on EUDAMED? Is company registration required and how is this done? I have an EU importer asking about our registration status. I read online that the launch of the database was postponed until May 2022.

    Thanks in Advance!


  • 2.  RE: EUDAMED Registration

    Posted 17-Nov-2021 12:22
    Edited by Chris Barkway 17-Nov-2021 12:22

    I'm not well versed in EUDAMED but have you read through the actor registration page?

    https://ec.europa.eu/health/md_eudamed/actors_registration_en

    Extracts from this page (underlined parts begin to answer your q's): 
    - On 1 December 2020 the European Commission has made available the Actor registration module. It is the first of six EUDAMED modules.
    -The Commission is not in a position to require the use of the Actor registration module until EUDAMED is fully functional according to the Medical Device Regulation and additional national requirements on registrations can therefore not be excluded.
    ...
    -Every economic operator (EU and non-EU manufacturers, authorised representatives, system/procedure pack producers and importers) has to register as an actor in EUDAMED and provide the required information.


    I would also check out the link on this page to the video 'Demo actor registration module'


    ------------------------------
    Chris Barkway
    Petersfield
    United Kingdom
    ------------------------------

    Original Message


  • 3.  RE: EUDAMED Registration

    Posted 17-Nov-2021 21:21
    Edited by Monoj Kalita 18-Nov-2021 23:19
    As Chris has said, the actor module is already online. If your importer is asking for your SRN then you can get one after registering by using the module. After going through the guidance provided in the link shared by Chris, you may follow these steps.

    1. Create a EU Login account
    2. Complete the EUDAMED Mandate Summary
    3. Complete the Declaration on Information Security Responsibilities
    4. Login using your EU Login account credentials.
    5. Select "Actor Registration Option" and upload the above two documents when asked.
    If you are outside the EU, you will need the SRN of your Authorized EU Rep. before you start your registration. Once you complete your registration steps, your application will first automatically go through your EU Rep. via the EUDAMED portal. Once they verify your information, it will be transferred to the Competent Authority. Usually you should receive your SRN in a couple of days. There is also a playground environment for EUDAMED, you can have a look at it before actually going into the real one.

    ------------------------------
    Monoj Mon Kalita, PhD
    Senior RA Specialist
    New Taipei City
    Taiwan
    ------------------------------

    Original Message


  • 4.  RE: EUDAMED Registration

    This message was posted by a user wishing to remain anonymous
    Posted 18-Nov-2021 17:01
    This message was posted by a user wishing to remain anonymous

    Hi Monoj

    Thank you for the information! This was extremely helpful. 

    Lori
    Original Message


  • 5.  RE: EUDAMED Registration

    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 Monoj,

    Follow up question for you regarding Actor Registration (Non-EU Mfr) if you can help. There is a step under the Actor Identification section that requests upload of an Organization identification Document. Do you know what this document is supposed to be? I'm not sure what is required for this. Also, would you know if an updated mandate document is needed if the original company listed on it had a slight name change? Thanks!
    Original Message


  • 6.  RE: EUDAMED Registration

    Posted 29-Dec-2021 09:34

    Hi again,

     

    The Mandate document is between you and your European Authorised Representative, check with them if they need a new one signed and then if they do you can add it to EUDAMED. To upload the updated mandate, I believe you may need to create a new version of your Actor which is a straightforward process.

     

    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: EUDAMED Registration

    This message was posted by a user wishing to remain anonymous
    Posted 30-Dec-2021 15:24
    This message was posted by a user wishing to remain anonymous

    Thanks Richard!

    I have not yet registered as an actor (only created an account) because I want to have all my ducks in a row! I'll check with them.
    Original Message


  • 8.  RE: EUDAMED Registration

    Posted 29-Dec-2021 20:52
    Hi Anon,

    Regarding the Organization Identification Document, I assume it is related to EORI (Economic Operator Identification and Registration) Number! My impression is that EORI is needed for any business or individual established in the EU as well as in some special cases few non-EU Economic Operators. Please google 'EORI number' to have a better understanding. If you don't have an EORI number, to my understanding, providing this 'Organization Identification Document' is also not needed. In addition to that, it is not mandatory to provide both EORI and Identification Document.

    ------------------------------
    Monoj Mon Kalita, PhD
    Senior RA Specialist
    New Taipei City
    Taiwan
    ------------------------------

    Original Message


  • 9.  RE: EUDAMED Registration

    Posted 30-Dec-2021 03:06

    Hi Monoj,

     

    The EORI number is a customs number, all companies don't need to have one. https://www.customssupport.com/en/news/what-eori-number-and-why-do-i-need-one

     

    This is not required and there is no direct connection between the organisation identification document and the EORI.

     

    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


  • 10.  RE: EUDAMED Registration

    Posted 30-Dec-2021 03:41
    Hi Richard,

    Thank you for clearing the doubts about EORI number, much appreciated. :)

    ------------------------------
    Monoj Mon Kalita, PhD
    Senior RA Specialist
    New Taipei City
    Taiwan
    ------------------------------

    Original Message


  • 11.  RE: EUDAMED Registration

    Posted 30-Dec-2021 04:28

    You're welcome Monoj.

     

    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


  • 12.  RE: EUDAMED Registration

    This message was posted by a user wishing to remain anonymous
    Posted 30-Dec-2021 15:24
    This message was posted by a user wishing to remain anonymous

    Hi Richard,

    In the EUDAMED actor registration video on the website, it shows the process of completing the actor registration. In the part I mentioned above, it asks for an Organization Identification document (something to show the company exists), but they didn't explain what type of document that would be. Wondering if you would know or can that part be skipped?
    Original Message


  • 13.  RE: EUDAMED Registration

    Posted 30-Dec-2021 16:30

    Hi Anonymous,

     

    The Organization Identification document is not mandatory for EUDAMED. You can skip it, if the competent authority needs more information they will ask for it so, for now, you can skip the field, it is not mandatory.

     

    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


  • 14.  RE: EUDAMED Registration

    Posted 18-Nov-2021 03:04

    Hi,

     

    All manufacturers wishing to sell their medical devices in Europe must register in EUDAMED. While the registration is currently voluntary there are more and more importers/distributors/Notified bodies/Authorised Reps etc asking for companies EUDAMED SRN which you receive after a successful registration.

     

    Non-EU companies must have a European Authorised Representative with a signed mandate before they can register for EUDAMED. If you do not want to complete the registration and user management yourself we offer a management service https://eudamed.com/index.php/product/eudamed_registration/

     

    The modules for actor registration, devices, and certificates are currently live and all are voluntary but as I mentioned above more and more companies are looking for device details to be in EUDAMED. If we can help with any of this please do contact 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


  • 15.  RE: EUDAMED Registration

    This message was posted by a user wishing to remain anonymous
    Posted 18-Nov-2021 17:02
    This message was posted by a user wishing to remain anonymous

    Hi Richard,

    Thank you for the information! I will keep you in mind if in need of your services.

    Lori
    Original Message


  • 16.  RE: EUDAMED Registration

    This message was posted by a user wishing to remain anonymous
    Posted 18-Nov-2021 17:02
    This message was posted by a user wishing to remain anonymous

    Question for you Richard about the signed mandate with the EU Authorized Rep. The actor registration requires start & end dates of the mandate. Is this referring to the start date of the CE marking and certificate expiration/end date of the CE mark status as listed on the declaration of conformity?? I'm not sure of the dates to which is is referring.

    Thanks in Advance,

    Lori
    Original Message


  • 17.  RE: EUDAMED Registration

    Posted 18-Nov-2021 23:13

    Hi Lori,

     

    The mandate summary you are referring to is simply a summary of the contract you are signing with your AR. Some AR's have requested the full signed contract. Within EUDAMED it is mandatory to enter the mandate start date, not the end date.

     

     

    This is the mandate or contract dates covering when this company will start being your representative, this is nothing to do with any CE or certificates dates it is only when you start doing business together.

     

    I hope this helps.

     

    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


  • 18.  RE: EUDAMED Registration

    This message was posted by a user wishing to remain anonymous
    Posted 19-Nov-2021 10:52
    This message was posted by a user wishing to remain anonymous

    Thanks Richard! I'll have to look into those dates. I am new to my current company and need to take in a lot of information all at once.
    Original Message


  • 19.  RE: EUDAMED Registration

    Posted 21-Nov-2021 02:33
    You're welcome. EUDAMED is certainly one of those subjects where there is a lot of information. Good luck with the new company, and with EUDAMED.


    ------------------------------
    Richard Houlihan
    CEO Eudamed.com
    ------------------------------

    Original Message


  • 20.  RE: EUDAMED Registration

    Posted 22-Nov-2021 12:39
    Dear Richard
    I've heard the postponement / postponement of Eudamed's functionality until 05/2024, is there any truth to it or is it a rumor / untruth.

    ------------------------------
    Evangelos Tavandzis
    Lead Auditor, Consultant
    Praha
    Czech Republic
    ------------------------------

    Original Message


  • 21.  RE: EUDAMED Registration

    Posted 22-Nov-2021 12:50

    Wow! 2024, that is a new one on me. For now the only definite is that the European Commission is saying publicly May 2022. However, my personal feeling is that it will be May 2023 but the official line remains 2022.

     

    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


  • 22.  RE: EUDAMED Registration

    Posted 22-Nov-2021 13:03

    Thanks for the information, I think the same as you, ie May, 2023.


    -----------------------------------------------------------

     Best regards

    Evangelos Tavandžis_QMD



    ------------------------------
    Evangelos Tavandzis
    Lead Auditor, Consultant
    Praha
    Czech Republic
    ------------------------------

    Original Message


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