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# EUDAMED API Reference (unofficial) | ||
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Unofficial API reference for EUDAMED, the European database of medical devices. | ||
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[View the API reference here.][html] | ||
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## Rationale | ||
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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. | ||
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Well, that's the theory. | ||
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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). | ||
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It's the best example of what happens when you develop "software by committee". | ||
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And it's not even feature-complete. Its timeline for completion has been postponed multiple times. It's still | ||
being developed as we speak. | ||
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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). | ||
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Not every regulator is bad at writing software: In the US, the FDA has launched a project called | ||
[openFDA][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. | ||
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Now, what to do in the EU? | ||
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The EU is not really delivering (at least before 2027, see below), but we can do some things about this. | ||
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We aim to achieve two things: | ||
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1. Build a better Eudamed search engine so that EU medical device innovation is no longer hampered by terrible | ||
software. | ||
2. Create transparency about APIs, so that others can hook into the data and contribute. | ||
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Goal #1 is solved by [BEUDAMED][beudamed], or "[Better EUDAMED][beudamed]", which we developed. It provides a | ||
much better user experience for searching across the EUDAMED data (think of it like Google Scholar | ||
vs. Pubmed). | ||
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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. | ||
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Maybe that will enable other developers to build useful software on top of EUDAMED in the future. | ||
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You still have ample time: EUDAMED is only planned to be complete by 2027. The timeline was moved most | ||
recently in July 2024. | ||
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## Contributing | ||
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You can view the API definition (which is a yml file) [here][yml]. The most straightforward way to edit it is | ||
to copy-paste its content into the [Swagger Editor][swagger-editor] (or the newer [Swagger Editor | ||
Next][swagger-editor-next], no clue which one is better). | ||
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Based on the yml file, this GitHub repository builds a HTML file with [redocly-cli][redocly-cli] and pushes it | ||
to the [GitHub pages site][html]. | ||
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Open a pull request if you'd like to propose changes. | ||
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## OpenRegulatory | ||
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Hold on, who the hell are we? | ||
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We're [OpenRegulatory][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. | ||
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For that purpose, we've published all our [MDR / ISO 13485 templates for free][templates] (also on | ||
[GitHub][templates-github]). And we've built a [QMS Software][formwork] 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. | ||
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That's it. Have a nice day! | ||
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.. 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. | ||
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<!-- Links --> | ||
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[html]: https://openregulatory.github.io/eudamed-api/ | ||
[openfda]: https://open.fda.gov | ||
[beudamed]: https://beudamed.com | ||
[yml]: eudamed_api_openapi_3_1.yml | ||
[swagger-editor]: https://editor.swagger.io | ||
[swagger-editor-next]: https://editor-next.swagger.io | ||
[redocly-cli]: https://redocly.com/docs/cli | ||
[openregulatory]: https://openregulatory.com | ||
[templates]: https://openregulatory.com/templates | ||
[templates-github]: https://github.com/openregulatory/templates | ||
[formwork]: https://openregulatory.com/formwork |