MDSS’ EUDAMED Updates!

EUDAMED

 

EUDAMED playground: MDSS’ SRN is DE-AR-000030861 

The EUDAMED playground is a useful tool for testing and training EUDAMED registration before moving to the productive system.

In addition, the use of the playground is mandatory for establishing Machine-to-Machine registration in EUDAMED: The manufacturer must install an Access Point in the playground to test the Machine-to-Machine registration.

The playground can be used with fake data, including fake company information.

However, if you would like to utilize MDSS GmbH’s presence as authorized representative in the playground, you will find us under the

Single Registration number (SRN): DE-AR-000030861 

What This Means for You 

The EUDAMED Playground can be embedded in the Manufacturer’s EUDAMED registration strategy to train “the real deal”. Where Machine-to-Machine EUDAMED registration is planned, it even has to be used as outlined in the EU Commission’s guide, available here.

Besides Machine-to-Machine, the other two methods for registering device in EUDAMED are manual registration and xml upload.

Still wondering which method to use? The EU Commission published below decision tree:

Source: EU Commission: EUDAMED user guide – Guidelines on Data Exchange with EUDAMED, Production v 2.27.0, 2026.

The above image is helpful, but more aspects should be considered.

 

The issue: The EUDAMED strategy has to be decided NOW to ensure continuous compliance! 

Many manufacturers initially say: “We will handle EUDAMED ourselves.

However, many reach out to us later—when challenges have already surfaced. At that point:

  • Data structures are already flawed
  • XML conversion approaches have been tried in vain
  • Valuable time has been lost

Contact us now for tailored assistance for your EUDAMED project.

Reach out to: eudamed@mdssco.com.

Click here to meet with us!

 

And don’t miss our upcoming online Seminar on “Getting EUDAMED Right — A Practical, Hands-On Guide“!