
EUDAMED: How To Use It, And Why It Sucks
And now, in the meantime, we have EUDAMED. And, boy, does it suck. The 82-page "user manual" doesn't make this any better. But let's not get ahead of ourselves.
Here's our walkthrough on how to use EUDAMED without going crazy, and without reading the 82-page manual. Let's see if that's possible.
Let's consider a few example scenarios for using EUDAMED and then see how to accomplish them.
Searching For Devices On EUDAMED
- Access the EUDAMED device search form.
- Ponder your life choices while you wonder which of the 15 form fields you need to fill out.
- If you're searching for a specific device, the most relevant fields are probably "Model / name" or "Trade name", in that order. You could also consider searching by nomenclature - click on "Browse nomenclature" to e.g. only search for "dialysis devices".
- Click search.
- Wait 15 seconds and ponder your life choices again.
- Don't attempt to right-click on search results to open them in new tabs. It won't work. You can only left-click.
- If you navigate to the next page (e.g. page 2) below, this will trigger a new search, so prepare to wait again.
Viewing Devices
- Manufacturer information
- Basic UDI-DI information
- UDI-DI information
The "UDI-DI information", however, in theory, contains information which only concerns this version of the device. In other words, it could theoretically change on EUDAMED when a new version of this device is released.
Yup. Confusing.
Anyway, from here, you can navigate to these other entities:
- Manufacturer: Click here to get more information about the manufacturer
- And that's it.
Cool. So that sucks. Let's look at how to search for other stuff next.
.. to be continued.
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Dr. Oliver Eidel
Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)
If you’re still lost and have further questions, reach out any time!