EUDAMED Information Centre - PROD

Register as an economic operator

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  1. Log into EUDAMED with your EU Login account (see Section 1.2.1). You will land on the User and Actor Registration page:

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  2. Select the Actor Registration widget on the User and Actor Registration page. A disclaimer is displayed before you are able to continue:

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  3. Read the disclaimer, select the "I have read the disclaimer" checkbox and click Next. You are prompted to enter generic information about the organisation to avoid duplicates:

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  4. The process summary highlights the completed, current, and the remaining stages of your EUDAMED action.

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  5. Select the role and country, enter the name of your organisation (actor) and click Next. A six- or seven-step process will guide you through you actor registration.

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  6. Enter the mandatory information fields, and additional fields, needed to identify your economic operator: VAT, EORI and National Trade Register Number etc. These cannot be updated via the User Interface and data exchange. However, it is possible to address the SANTE EUDAMED SUPPORT with requests 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. You can upload any document that may be useful for validating your request – but only in PDF format.

    EORI number: All businesses and individuals trading in the EU need an EORI. You can validate your number in the EORI database. If you have no EORI, contact the customs authorities in the country where you are registered. Its provision is optional however.

    Click Save & Next.

    1. If you register as a Non-EU Manufacturer, you will be prompted by an Authorized Representative selector screen:

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      Note

      If you do not find your authorised representative from the search page, please contact them to confirm their Actor ID/SRN. They may not have registered yet or may have registered under a different name.

      You don’t have to upload the full mandate text. It’s enough to upload a summary/ extract with the start/end dates, details of the manufacturer and authorised representative, and list of generic device groups covered by the mandate.

    2. Alternatively, for EU Manufacturer or any other type of actors (AR, PR, IM), you will be prompted by the Actor address details screen:

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      Note

      After entering all the required Authorized Representative data, in the case of a Non-EU Manufacturer, you also will be prompted by an Actor address details screen.

  7. Enter the address details for your economic operator (you can select No if you prefer not to enter street-level information), and click Save & Next.

    You will be prompted by the Contact Details screen:

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  8. Enter the email addresses and other useful information regarding the contact points in your organisation. There are separate fields in which to enter contacts relevant to competent authorities, and those to be displayed to the public, and click Save & Next.

    You will be prompted by the Regulatory Persons screen, so that you to identify one or more regulatory person(s) within your organisation:

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    Note

    Regulatory person contact

    The person in your organisation who is responsible for ensuring regulatory compliance. See Article 15 of Regulation 2017/745.

  9. Enter the details of this person and specify their area(s) of responsibility. To add another person with this role, select 'Add a new Regulatory person', and click Save & Next.

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    Note

    Local Actor Administrator (LAA)

    The person who first enters the details of an actor in EUDAMED automatically becomes the LAA for that actor, once the registration has been accepted.

    As LAA, you can manage all the details for your actor in EUDAMED (e.g. name, address, contact details, etc.) as well as user access requests for it (see Section 2.2.2: Validating user access requests2.2.2 Validating Economic Operators access requests).

    It is good practice for each actor to identify at least two LAAs (with at least one belonging to the actor itself, rather than all sub-contractor contacts).

  10. Check and complete the information on the page. Upload the signed declaration – in PDF format only – using the Browse button.

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    Note

    If you specify that you are a 'sub-contractor', an additional section at the bottom of the page will prompt you to provide your sub-contracting company details.

  11. Click Save & Next to move to the last step, providing ‘Competent Authority’ details. You can add any extra information you think it might be relevant:

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  12. If there are multiple competent authorities that could validate your request, select the most appropriate one from the list. (A help file will be available for German authorities, to assist with selection). If there is only one authority that can validate your registration, details will be pre-populated. To view a summary of your completed registration form, click Preview.

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  13. Review the information on the form, and then click Submit actor registration at the bottom of the page. A confirmation window will appear:

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  14. Read the information here and then click Confirm.

    • Your registration request is immediately saved and appears with a 'Submitted' state in your 'Pending requests' list.

    • It is given a unique application ID and submitted to the competent authority:

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  15. You will be notified when your application is approved or rejected.

    Note

    The validation of the Actors registration requests are under the responsibility of the different national Competent Authorities (CAs).

    We only provide a technical Support for EUDAMED application. (For non-EU requests, verification of non-EU actor registration requests are completed by authorised representatives and) validation of requests are completed by the responsible CA. Therefore, you may wish to contact your relevant (authorised representative or) National Competent Authority.

    A list of national contact points can be found on the EUDAMED website:  https://ec.europa.eu/tools/eudamed/#/screen/competent-authorities

If your registration is approved (except non-EU manufacturers)

  1. The next time you enter EUDAMED, you will be prompted to accept your rights and obligations as the Local Actor Administrator for the actor. You can download the disclaimer by clicking on Download disclaimer in the orange box:

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  2. Click on I accept the user rights and obligations and then click Next. You will be prompted to validate your email address for the Actor module:

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If your registration is rejected (except non-EU manufacturers)

  1. If your request is not approved, it will remain in your pending requests list. The next time you enter EUDAMED, your start page will be 'My pending requests', listing your registration requests and their states:

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  2. Click the three-dot action button beside your request. You can view and edit your registration request if it has a 'Correction requested' state.

    Important

    Requests with a 'Refused' state cannot be edited or resubmitted. The reason given by the competent authority for the rejection is displayed

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  3. For requests flagged as 'Correction requested', edit and resubmit them for validation as appropriate.