EUDAMED Information Centre - PROD

Actor registration – FAQ

General questions

  1. Can I make the Regulatory Persons details invisible to the the general public?

    The PRRC should have its data made available to the public, as the MDR mandates so. Please see Article 31 (7) (data entered in Eudamed should be publicly available), in conjunction with paragraph 1 of the same article, which refers to Annex VI Section 1, which indeed includes the PRRC in point 1.4.

    The recommended standard is to not use “private” email addresses, but professional and dedicated ones (like FMB ad hoc for this use).  Absolutely no invention of Alias Names for the PRRCs. This would be considered false data.

  2. How can I see my pending Actor registration request for the second Actor if this is still pending or has been rejected?

    Once you are logged into your account, on the homepage, click on the link with your name (top right corner) and scroll down till the end of the page, click on “See my pending Requests”.

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  3. When linking our actor profile to non-EU manufacturers, there is no delete button to delete a manufacturer from the listing, even when the end date is passed. It is only possible to modify the starting and end dates. Can an importer delete manufacturers for which they do not import anymore?

    No, there is no possibility to delete the link between a manufacturer and an importer. We keep this link as an historical version for traceability reasons. The end date tells you if the link is still active or not.

  4. My actor registration request has been pending for a long time without reaction. Who should I contact?

    Firstly, please ensure that you are on the production environment of EUDAMED (https://webgate.ec.europa.eu/eudamed), not the playground environment. You can easily identify the playground because the European Commission logo on the top of the page has a red banner across it stating "Play". Once you have confirmed this:

    You should contact the competent authority responsible for validating your pending actor registration request. Contact details can be found on the public EUDAMED site at https://ec.europa.eu/tools/eudamed/#/screen/competent-authorities.

    If your actor registration request requires verification by an authorised representative and is still in the state "Submitted", you should contact the authorised representative. These can be searched on the EUDAMED public site at https://ec.europa.eu/tools/eudamed/#/screen/search-eo.

  5. How can I check if my organisation is already registered?

    Registered organisations can be found on the public EUDAMED site at https://ec.europa.eu/tools/eudamed/#/screen/search-eo

  6. My organisation undertakes more than one role. Can I register as more than one actor in EUDAMED or will I be stopped by the duplicate check?

    Yes, your organisation can register more than once - you need to have one actor ID/SRN for each role. If your organisation is a manufacturer and importer, you should register separately for each role. The duplicate check is performed on the same actor type: an actor registering a second time with the same name and address but for another actor type will not be marked as a duplicate.

  7. How does EUDAMED check for duplicate actors, and will this prevent me from creating more than one actor role for my organisation?

    The duplicate check is performed on certain fields (name, address, VAT, EORI) for each separate Actor type, so an Actor registering a second time with the same name and address but for another actor type will not be marked as duplicate.

    The duplicate check is a warning for the CA who is validating your request. It does not prevent you from submitting an actor registration request, however it is advised to add a clear justification when prompted in order to avoid potential confusion or rejection by the CA.

  8. I have submitted my actor registration request but I lost my application ID. Where can I find it?

    You can find your application ID on 'My pending requests' page. 

    If you have no actor registered yet, this page is your homepage when accessing EUDAMED.

    If you have 1 or more actors registered, on the 'My Actors' page, which is your homepage when accessing EUDAMED, click on 'See my pending Requests' link (bottom left).

    If you have already selected the actor you want to work with from the dashboard, click on the link with your name (top right corner) and scroll down till the end of the page and click on “See my pending Requests”.

  9. I spotted a mistake in my application form after submitting it. To prevent my application from being rejected, how can I submit a correction?

    Once the registration is submitted, no update is possible. You can contact the CA. The CA will reject the request with the reason "Correction needed". You can then make the correction and resubmit the request.

  10. What is the EORI number?

    The EORI number (Economic Operators Registration and Identification number) is an identification number, unique in the customs territory of the European Union, assigned by a customs authority to an economic operator or to another person with a view to registration for the purposes of customs. It is used in all customs procedures when exchanging information with customs administrations.

    The EORI number is optional for the EUDAMED registration.

  11. How can I update the details of my actor?

    If you have the 'Local actor administrator profile (LAA)', from your dashboard, go to the 'Tasks' section & 'My Actor data' and click on 'Manage your actor data' link. From this page, you can 'create a new version' of your actor data.

  12. Can I update my EORI, VAT or National Trade Register numbers?

    The EORI, VAT and National Trade Register Number cannot be updated via the User interface and data exchange. However, it is possible to address the SANTE EUDAMED SUPPORT with a request to change one of these items. The request will be assessed, and possibly performed, on a case-by-case basis depending on the justification for such change.

  13. Do competent authorities need to validate updates to actor data?

    No. Only the initial actor registration request is validated, updates will be notified to the competent authority but they do not need to be validated explicitly.

  14. How do I change my actor notification email address?

    Click on your name on the top right of the screen to access the settings. As the LAA, you can update the email address for each module under "Actor notification email addresses". New actor registration emails will go to the address for the actor module.

    Some emails (e.g. when an actor ID/SRN has been generated) will also go to the LAA's account email listed on this page. All notifications of the same type begin with the same code, so you can use rules in your email client to direct them to folders of your choice.

    Only the LAA for an actor can update the actor notification email address.

  15. I have registered as an actor in EUDAMED. How do I submit another actor registration request?

    Click on your name on the top right of the screen to access the settings. The bottom of this page contains two buttons - one to submit a new actor registration request and one to submit a new access request. Alongside these, you will see the link to access your pending requests.

  16. Where can I indicate whether my authorised representative may submit incident reports and corrective actions for devices covered by the mandate?

    This option to delegate Vigilance reports to an authorised representative (AR) is available during actor registration and via the mandate management page (TBC). If a device is registered, EUDAMED will know which AR is associated with that device. When this option is selected, the AR will be able to submit Vigilance reports on behalf of the manufacturer only for devices already registered (with the same AR) by the manufacturer and for which the mandate is active.

  17. Can I change the LAA for my actor?

    Yes, but you need to follow these steps: 

    1. Add a second LAA to the actor.

    2. The new LAA terminates the redundant LAA.

  18. How can I add a second LAA?

    You need to submit a new access request for the LAA profile and the current LAA needs to approve it.

  19. I am registered in EUDAMED as a user for a manufacturer. Can I also register for a Notified Body?

    No. A user cannot belong to both a supervising authority and an economic operator at the same time.