Selecting an EUDAMED Submissions Partner

Selecting an EUDAMED Submissions Partner

Recently while chatting with various manufacturers about their EUDAMED strategies and with various MedTech consultancies on their client’s strategies it has become clear there is still a lot of misinformation regarding EUDAMED. I am going to address this here and in a second article I will give some tips for testing the services of these companies.

Misinformation

Firstly, EUDAMED is working, we in EirMed have uploaded thousands of UDI DIs to EUDAMED Production and Playground databases. The Playground on occasion has some issues because of deployment errors but this is a sandbox not a validated application, it is not always like for like with Production.

EUDAMED Production is the fully working version. The device submission module on EUDAMED Production is working and performing as it should. There is nothing wrong with it. Sometimes there are differences between Production and the Playground, this is because the Playground is a sandbox, the European Commission’s first live deployment of code. This is not a user acceptance test system, this is the first public installation to show/demo new functions or requirements from the different modules so you should only use it to complete some cursory tests.

The Playground is ideal for your initial UDI DI uploads, a place to catch errors related to rule violations and wrong data in the various XML fields. It is not your QA, OQ, and PQ test bed as there can be differences against Production, ideally, there shouldn’t be however bugs can be fixed and functions change on the Playground long in advance of a Production deployment. So use the Playground for initial uploads just to make sure your XML structure is correct and the rules are met but for fully validated testing Production is the location.

For accurate testing upload a small amount of UDI DIs so you can easily discard them if they are accepted but for you the data is incorrect. There is a discard function in EUDAMED where you can discard each UDI DI and on the final UDI DI it also discards the Basic UDI. These UDI DIs are discarded manually one by one, hence the reason I suggest uploading a small amount to test. 

Some of our EUDAMED submission competitors have been telling manufacturers that EUDAMED is unstable, and not fit for purpose, and because of this their development and testing are ongoing. They are not onboarding clients until EUDAMED is stable, the translation of this statement is ‘our systems are not ready’. So please if you get an excuse like this walk away, after their system is ready there will most likely be many bugs to iron out. The EirMed (eudamed.com) systems are ready, and we are onboarding clients every week. All bugs found were fixed a couple of years ago, and we are ready to get your data into EUDAMED.

If you have built your own system, well done that was a massive investment and one you will keep paying for for many years Or indeed if you are using a more cost-effective 3rd party system like ours, you need to test your EUDAMED submissions. Companies telling you that EUDAMED is not ready, not stable, and there is no rush on submitting your data is 100% misinformation and incorrect. EUDAMED will be mandatory after Q4 2025, this leaves what appears to be loads of time however based on our experience it can take companies over a year to get all their data collated and ready to submit. Having expert support can substantially reduce this time but you need to start ASAP, and if you have the data ready what is holding you back from submitting it to EUDAMED Production?

In the next article, I will give you tips on how to test your submission partner system.

If you are looking for expert EUDAMED advice, premium support, training, and data submission management please do come and talk to us.

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