EU Medical Device Classifier
Classifies medical devices under EU MDR rules and checks documentation gaps for CE marking.
by borghei · ★ 976 on GitHub
What it does
You describe the device's intended use, how it contacts the body, and whether it includes software. Claude classifies it under the correct MDR rule and checks your technical documentation and clinical evidence against requirements. You get a classification result and a gap analysis.
Who it’s for
A good fit for healthcare professionals and health businesses and people who review contracts and legal documents.
Do you need to code?
No. You can use this without writing or editing any code.
How to install
Add it as a skill, or as part of its plugin. This skill also ships inside a plugin, so you can upload just this skill to Claude, or install the whole plugin it comes in. See the step-by-step guide.
Safety note
Runs a bundled Python script on your computer; gives regulatory guidance, not legal advice.
Script files included: 1
As with any add-on, only install skills from sources you trust, and read what it does first.
License
MIT