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Request the use of a new AP

vid-icon.jpg VIDEO: eDelivery access points

Note

Economic Operators can have up to two APs in active/submitted/connectivity under validation statuses while Competent Authorities, Designating Authorities and Notified Bodies can have only one AP in active/submitted/connectivity under validation statuses. See Annex 3 (AP statuses) page for further information about the AP statuses.

  1. Log into EUDAMED as a Local Actor Administrator (LAA). Under the My Actor data section click on the Access point management link:

    EUDAMED access point management link in the dashboard

  2. Click on the Request a new M2M access button:

    EUDAMED request a new machine to machine access button when requesting the use of a new access point

  3. Agree to the disclaimer and click on the Next button:

    EUDAMED machine to machine request access disclaimer

  4. In the next screen select No to create a new AP and click on the Next button:

    EUDAMED will you use an existing EUDAMED access point field when requesting the use of a new access point

  5. Select the owner of the AP:

    1. If you own the AP, you must select if you will share this AP or not. The Organisation details will be prefilled:

      EUDAMED organisation details when requesting the use of a new access point

    2. If the AP is owned by a 3rd party company, the May this access point be used by other Actor(s)? field will be greyed out and you will be asked to upload the 3rd Party Agreement:

      EUDAMED third party agreement upload when requesting the use of a new access point

      Note

      3rd Party Agreement

      The 3rd Party Agreement document is to confirm that a company (either a 3rd party provider or another Actor registered in EUDAMED having already an AP) agrees to act as 3rd party service provider for the Actor organisation that submits the request for the purposes of M2M DTX with EUDAMED.

      This document will be used to assess the validation of the AP access/link request and must be provided for each environment where an AP access/link is requested (Playground and Production).

      This document must identify clearly the two parties (Actor and 3rd party service provider) and must be signed by both parties for confirming the agreement from the 3rd party service provider toward the Actor.

      You can download the 3rd Party Agreement template here.

      You must upload a PDF file in the 3rd Party Agreement field.

      Enter information related to the Organisation:

      EUDAMED details on the organisation when requesting the use of a new access point

  6. Enter the name of the AP in the Access Point field, the country and the city of the AP, then select Yes if you use this AP in other eDelivery application or No otherwise and click on the Save & Next button:

    EUDAMED name, country and city of the access point fields and save and next button when requesting the use of a new access point

  7. In the next screen fill in your technical and legal contact details:

    EUDAMED technical and legal contact details when requesting the use of a new access point

    Note

    Technical contact: The technical person to contact for setting up the AP and for any related technical issues.

    This person must belong to the organisation that owns the AP (if the owner is a 3rd party provider, the technical contact should belong to the 3rd party provider; if the owner is an Economic Operator, the technical contact should belong to the Economic Operator).

    Legal Contact: The person to contact in case there is a non-technical issue with the way the AP is used (e.g., misuse) or for notifications in case of maintenance/bug etc. that impacts the use of the AP.

    This person must belong to the Actor's organisation submitting the request.

  8. Upload your Business justification:

    EUDAMED business justification/proof of testing field and browse button when requesting the use of a new access point

    Note

    In the Business justification / Proof of testing field use the Business justification document if you are a Playground user and the Proof of testing document if you are a user of the Production environment. See the EUDAMED environments page for further information about the existing environments accessible to the users.

    Important

    Business justification

    Before having an AP in the Production environment all participants must apply for an AP in Playground in order to test the service. When submitting an AP request in Playground your are required to provide a business justification. This document is required only in Playground.

    The business justification must be consistent as the AP in Playground will be a real one and requires investment from both sides. If the documents attached to the Playground AP request are dummy or inconsistent the request will be rejected.

    The business justification must confirm that the Actor has the capacity, the resources, the required database, and the need to use M2M DTX with EUDAMED because the amount of data to exchange is important enough for the required investment to set-up an AP and provide the data exchange estimated periodicity and load EUDAMED can expect.

    You can download the Business justification template here.

  9. Select the services that you want to use this AP for and click on the Submit button:

    EUDAMED services per module and submit button when requesting the use of a new access point

    Note

    You will be able to edit the selected services after the activation of your AP. Each service can be linked to only one AP. See section Generate your security key for more information.

  10. Select Yes in the pop-up window to complete the AP registration:

    EUDAMED complete access point registration confirmation window when requesting the use of a new access point

    Note

    If you select Yes your request will be stored as submitted. Otherwise, your request will be stored as draft (see Annex 3 (AP statuses) page).

  11. In the next screen you can see a confirmation message and the AP’s Party ID. Click on the Go back to Access Point Link dashboard link to manage your AP:

    EUDAMED go back to access point link dashboard link when requesting the use of a new access point

Note

EUDAMED team at the Commission will either accept or reject your request. If your request is rejected then the status of your request will be rejected and you will be able to request again. Otherwise, the status of your request will be connectivity under validation (see Annex 3 (AP statuses) page). Upon EUDAMED team's decision (request accepted/rejected), you will get a notification in your Notifications Inbox:

EUDAMED notifications inbox

Important

After your request is approved and the status of your request is connectivity under validation you must configure your AP to proceed with the onboarding. See How to configure your AP for further information.