EU AI Act compliance for medical AI, without doing it twice.
The AI Act plugs into your MDR/IVDR route, it does not sit beside it. We map what your conformity already covers and what the AI Act adds, so you extend one file instead of running two.
It feels like doing the work twice. It does not have to.
You already live under the MDR/IVDR: technical documentation, clinical evaluation, a notified body, ISO 13485. Then the AI Act looks like a second regime bolted on top. The industry (MedTech Europe, COCIR, DIGITALEUROPE) has named the duplication. But the AI Act was written to plug in, not to sit beside.
One integrated pathway, in three steps
Classify
Your MDR/IVDR class decides it: a notified body means high-risk AI (Art 6(1)).
Map
Obligation by obligation: what your MDR/IVDR and ISO evidence covers, what the AI Act adds.
Prove
Inside your MDR/IVDR assessment (Art 43(3)), a dated, cited record.
Cited to the official regulation (Art 6, 43(3)) and MDCG 2025-6 guidance.
EU-hosted, privacy-first. Your inputs stay yours.
A dated, cited compliance record, not legal advice.
The knowledge base for medical AI + the AI Act
Every legal claim cited to the official regulation.
Building medical AI? Be a design partner.
Test the tool on your real system and help shape it, free. We are looking for a few medical-AI teams to build with early.
Want the filed, defensible compliance record when it ships?
We are building the dated, cited AI Act record for medical-AI teams. Join as a founding member for early access and a say in the roadmap.
Double opt-in. Unsubscribe anytime. Not legal advice.
Legalithm provides compliance information and tooling, not legal advice. Classification depends on your intended purpose and device qualification.