Unofficial API reference for EUDAMED, the European database of medical devices.
More links:
- BEUDAMED announcement and rationale: Launch post of BEUDAMED and summary of problems of EUDAMED
- BEUDAMED: Better EUDAMED search engine. Use this to explore EUDAMED data in a fast, modern and user-friendly way.
- EUDAMED: The original search engine, whose API this repository refers to. Use this to explore EUDAMED data in the, umm, original way.
The introduction of a unified database for medical devices across all European countries is a good idea - it creates transparency, collects all data in one place and reduces overhead as each country no longer has to maintain their own infrastructure.
Well, that's the theory.
Unfortunately, EUDAMED has, politely speaking, not really delivered upon those promises. Its user experience is somewhere between "huh, this feels like Windows 95" and "I'm throwing my computer out of the window now". Running a search easily takes 5 - 10 seconds. You can't right-click on links (?), so good luck managing your research in multiple tabs (you can't).
It's the best example of what happens when you develop "software by committee".
And it's not even feature-complete. Its timeline for completion has been postponed multiple times. It's still being developed as we speak.
This is saddening to see, because it hampers innovation and makes people unhappy: Every minute in the EU, there's probably a person wrestling with EUDAMED and throwing their hands up into the air (or their computer out of the window).
Not every regulator is bad at writing software: In the US, the FDA has launched a project called openFDA which provides both a simple API to access data, and machine-readable data dumps of all data for offline processing. It's very cool.
Now, what to do in the EU?
The EU is not really delivering (at least before 2027, see below), but we can do some things about this.
We aim to achieve two things:
- Build a better Eudamed search engine so that EU medical device innovation is no longer hampered by terrible software.
- Create transparency about APIs, so that others can hook into the data and contribute.
Goal #1 is solved by BEUDAMED, or "Better EUDAMED", which we developed. It provides a much better user experience for searching across the EUDAMED data (think of it like Google Scholar vs. Pubmed).
Goal #2 is solved by this repository. While building BEUDAMED, we learned a lot about the EUDAMED API and data structure (spoiler: it's a mess), so we've summarized all our learnings here and hope that other people will contribute.
Maybe that will enable other developers to build useful software on top of EUDAMED in the future.
You still have ample time: EUDAMED is only planned to be complete by 2027. The timeline was moved most recently in July 2024.
You can view the API definition (which is a yml file) here. The most straightforward way to edit it is to copy-paste its content into the Swagger Editor (or the newer Swagger Editor Next, no clue which one is better).
Based on the yml file, this GitHub repository builds a HTML file with redocly-cli and pushes it to the GitHub pages site.
Open a pull request if you'd like to propose changes.
Hold on, who the hell are we?
We're OpenRegulatory, and it's our mission to enable for medical device innovation by making it much easier, affordable and transparent to comply with medical device regulations.
For that purpose, we've published all our MDR / ISO 13485 templates for free (also on GitHub). And we've built a QMS Software which enables lean, founder-led Healthcare startups (like yours?) to enter the market faster, because a lot of the regulatory documentation gets automated by it.
That's it. Have a nice day!
.. and I hope browsing the EUDAMED API documentation is less painful for you than it was for me when I was writing it. Because it's truly a mess.