EU AI Act for Healthcare AI Companies — Scanara
EU AI Act compliance for AI systems in healthcare and medical devices. Annex I medical device intersection, CE marking path, and Scanara scanning for clinical AI.
The double compliance burden for healthcare AI
MDR + EU AI Act: two frameworks, overlapping scope
AI systems that qualify as medical devices face compliance requirements under both MDR/IVDR and the EU AI Act. Understanding where obligations overlap — and where they diverge — requires careful legal and technical analysis.
CE marking path confusion for AI
The EU AI Act Annex I pathway for medical devices is designed to reduce duplication, but navigating it requires understanding when your existing CE marking covers EU AI Act obligations and when it does not. Most medical AI teams need guidance here.
Notified body costs and timelines
Notified body assessments for medical devices are expensive and time-consuming. Where a notified body is not required for EU AI Act compliance, automated conformity assessment reduces cost significantly. Knowing which path applies is critical.
How Scanara helps healthcare AI companies
Annex I + Annex III path classifier
Scanara classifies your healthcare AI system against both the Annex I medical device pathway and direct Annex III categories. The output tells you which compliance path applies and what obligations remain after your MDR/IVDR CE marking is accounted for.
MDR + EU AI Act overlap detection
Scanara's scanner flags code patterns and documentation gaps that trigger obligations under both MDR and the EU AI Act, and indicates which framework's requirement takes precedence or whether both must be satisfied independently.
Clinical AI-specific rule patterns
Scanara includes rules tailored to clinical AI use cases: explainability for diagnostic recommendations (Article 13), human oversight for treatment decisions (Article 14), and accuracy and robustness validation (Article 15).
Technical file documentation for MDR + EU AI Act
Scanara generates documentation that satisfies both MDR technical file requirements and EU AI Act Annex IV requirements in a single output, reducing duplication between your QMS and compliance dossier.
Compliance costs for healthcare AI
€80K+
Typical cost of a notified body assessment for a Class IIa medical device AI — before EU AI Act compliance is layered on top. Automation reduces the preparatory documentation cost significantly.
€15M
Maximum EU AI Act fine for high-risk AI system non-compliance. Healthcare AI that causes patient harm while non-compliant faces additional liability under product safety legislation.
Frequently asked questions
Clarify your MDR + EU AI Act compliance path
See how Scanara classifies your healthcare AI system and maps your obligations across both regulatory frameworks.
See demoHow Scanara Helps
Scanara automates EU AI Act compliance from code to dossier. Connect your GitHub repos and get compliance reports in minutes.