Using a third-party EUDAMED access point: agreement and contact ownership
The acquired new-access-point help requires a third-party agreement identifying and signed by both parties for each requested environment. It also separates the AP owner’s technical contact from the requesting actor’s legal contact. Prepare those responsibilities before the link request.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
Sourced criteria · EU · EUDAMED
What changes the service scope?
Decision or task
What the source describes
What to prepare
request-the-use-of-a-new-ap / HTML p [24]
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. [1]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
request-the-use-of-a-new-ap / HTML p [25]
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). [2]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
request-the-use-of-a-new-ap / HTML p [26]
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. [3]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
request-the-use-of-a-new-ap / HTML p [28]
You must upload a PDF file in the 3rd Party Agreement field. [4]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
request-the-use-of-a-new-ap / HTML p [36]
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). [5]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
request-the-use-of-a-new-ap / HTML p [38]
This person must belong to the Actor's organisation submitting the request. [6]
Apply this source context to the specific tasks below; retain missing facts and review current target-environment compatibility.
Dated technical/help evidence, not a complete legal duty set or live EUDAMED response. Current target-environment release, business rules, permissions and actual buyer records remain unresolved. Blank dictionary flags are unknown; occurrence and update notes keep their stated conditions. No credentials, registration deadline or completed production exchange is inferred.
Prepare the Using a third-party EUDAMED access point work package
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Identify the parties and environment
Record the actor, AP owner and whether this is Playground or Production; review an agreement for that environment.
Useful evidence: A signed agreement naming both parties and the requested environment.
Assign the correct contacts
Confirm that the technical contact belongs to the AP owner and the legal contact to the requesting actor.
Useful evidence: A responsibilities/contact matrix retained privately in the implementation project.
Check the submission package
Have the integrator review the required PDF, actor/AP identifiers, services and onboarding evidence before submitting through EUDAMED.
Useful evidence: A reviewed link-request package and supported service list.
Work packages and dependencies
Conditional: Using a third-party EUDAMED access point: agreement and contact ownership — Review the actual current records and target-environment requirements; complete the specific mapping/onboarding or maintenance task with source/version and acceptance evidence.
Questions for providers
How will you resolve the specific field/identity or state dependencies shown here for our actual records?
Which current environment release, permissions and business rules support the proposed operation?
What mapping, unresolved-error and acceptance evidence will you hand over, and who owns each correction?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
