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Getting Started with EUDAMED Onboarding

In this section you will find a high-level overview of the main steps required for EUDAMED onboarding.
All detailed instructions, screenshots, and helpful tooltips are available directly in the UDI solution for every single step. Hero Light
Environment Info: EUDAMED onboarding takes place in two environments: the Playground (test) and the Productive environment.
SRN Info (Single Registration Number): The same economic operators are used in both environments, but each environment requires a different SRN.

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Part 1: EUDAMED Playground Onboarding

Before starting this process, please make sure that you have already created your actor within the EUDAMED Productive environment and playground environment. This is the prerequisite to start the Access Point Management and Security Token generation we support in this section.
Onboarding 1
1

Add Economic Operator (p36 UDI Solution)

  • Enter Actor ID/SRN, Role, and Regulatory Actor in the Playground table in the p36 UDI Solution.
  • Review your entries to ensure accuracy before proceeding.
2

Download & Sign 3rd Party Agreement (p36 UDI Solution)

  • Download the 3rd Party Agreement template from the p36 UDI Solution.
  • Complete your company details and sign the document.
3

Download & Sign Business Justification (p36 UDI Solution)

  • Download the Business Justification template from the p36 UDI Solution.
  • Complete your company details and sign the document.
4

Configure Access Point (EUDAMED Playground)

  • In EUDAMED Playground, request a new M2M access point and reference the p36 Access Point.
  • Upload the signed 3rd Party Agreement and Business Justification, complete contact details, select all UDI/Device services, and submit.
5

Generate Security Token (EUDAMED Playground & p36 UDI Solution)

  • After approval, generate a security token in EUDAMED Playground for the UDI/Device module.
  • Copy the token immediately and enter/save it in the p36 UDI Solution.
6

Submission Test & Proof of Testing (p36 UDI Solution)

  • In the p36 UDI Solution, start a submission test for each actor and send a UDI-DI to EUDAMED Playground.
  • When successful, download the Proof of Testing document from the p36 UDI Solution.

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Part 2: EUDAMED Productive Onboarding

The Proof of Testing document must be available before starting productive access point management!
  • Playground SRN and Productive SRN are different.
  • Once the status is set to “Completed”, you can start productive submissions.
Onboarding 2
1

Add Economic Operator (p36 UDI Solution)

  • Enter the correct Productive SRN/Actor ID for each actor in the Productive table in the p36 UDI Solution.
  • Double-check all details to avoid mismatches with the Playground setup.
2

Download 3rd Party Agreement

  • Download the 3rd Party Agreement template from the p36 UDI Solution.
  • Complete your company details and sign the document.
3

Configure Access Point (EUDAMED Productive)

  • In EUDAMED Productive, configure the access point as in Playground, referencing the p36 Access Point.
  • Upload the 3rd Party Agreement document and Proof of Testing document and wait for EUDAMED approval.
4

Generate Security Token (EUDAMED Productive & p36 UDI Solution)

  • After approval, generate the productive security token in EUDAMED Productive.
  • Copy the token immediately and enter/save it in the p36 UDI Solution.