diff --git a/README.md b/README.md index db5a155..2ecd22e 100644 --- a/README.md +++ b/README.md @@ -1 +1,97 @@ # EUDAMED API Reference (unofficial) + +Unofficial API reference for EUDAMED, the European database of medical devices. + +[View the API reference here.][html] + +## Rationale + +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][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: + +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. + +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). + +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. + +## Contributing + +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). + +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]. + +Open a pull request if you'd like to propose changes. + +## OpenRegulatory + +Hold on, who the hell are we? + +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. + +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. + +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. + + + + +[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