EUDAMED: How To Use It, And Why It Sucks
When the MDR came into effect, the European Commission also started building EUDAMED, which should server as a central database for all medical devices within the EU. That sounded, like a great idea, because in the past, all 27 EU member states had to build their own medical device database, which obviously means that 26 EU member states somewhat re-invented the wheel as this sort of thing had already been built before.
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.
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
You want to search for medical devices. Here's how you do it:
- 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.
In some cases, the search is unsuccessful and you see a red error box displaying "Internal server error". In that case, you're screwed, try again later. If, however, you were lucky and the search worked, you are now presented with a list of devices matching your search. Now, when navigating those search results on EUDAMED:
- 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
Now, when you're viewing a device, the EUDAMED page is separated into three distinct sections:
- Manufacturer information
- Basic UDI-DI information
- UDI-DI information
You think this is confusing? Wait until you actually look into MDR UDIs.. the mess has just begun. Anyway. The important aspect to note is that the "Basic UDI-DI information" contains data which concerns the entire devices, across device versions. In other words, if you're looking at a scalpel medical device, this is data which will likely not change across device versions. Like, it will always be a hardware device used during surgery (at least that's what doctors used scalpels for when I studied medicine).
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:
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.
From other parts of EUDAMED, you can actually navigate to the page with shows more Basic UDI-DI information, but apparently not from the device page. Bad luck.
Cool. So that sucks. Let's look at how to search for other stuff next.
.. to be continued.
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
I’m a medical doctor, software engineer and regulatory dude. I’m also the founder of OpenRegulatory.
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!
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!