EUDAMED and .xml Bulk Upload Files - How Do They Work?

Question

Hi there!

With EUDAMED looming 5 months out from now everyone is hard at work getting their data in order, ready for submission. However, one of the methods of data upload remains slightly confusing: the .xml Bulk Upload function. I have seen numerous companies try to set up the .xml files themselves, fail, and resort to purchasing expensive Excel templates from consultants, etc. Plus, EUDAMED support does not offer much help in setting-up .xml files, thus I have a question: 
• How do you set-up a functioning .xml file using the .xsd schemas provided by EUDAMED that is importable to Excel for data entry?

Thank you sincerely for your time!

Dr. Oliver Eidel · Answer

That's a great question! Long story short, EUDAMED is a complete mess and, based on our estimations here, has already cost €40M and counting.

There are some (shady) consultants which offer some sort of software for xml bulk uploads but, to my knowledge, most of their software looked pretty crappy.

So your options unfortunately boil down to building this yourself or entering the data manually.

That being said, we might look into building an open solution here and maybe adding that to Beudamed. We'll keep you posted :)

EUDAMED and .xml Bulk Upload Files - How Do They Work?

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