Healthcare AI Compliance
AI in healthcare is among the most heavily regulated. The EU AI Act adds new requirements on top of existing Medical Device Regulation (MDR). Navigate both with confidence.
Dual Regulation Alert
Most healthcare AI is covered by BOTH the EU AI Act AND the Medical Device Regulation (MDR). Article 6(1) makes AI that's a safety component of a regulated product automatically high-risk.
- Extended timeline (Aug 2027 for Annex I products)
- Notified Body assessment often required
- Technical documentation must satisfy both
Healthcare AI Under Regulation
From diagnostics to drug discovery, healthcare AI faces the most complex regulatory landscape.
Medical Imaging AI
AI that analyzes X-rays, MRIs, CT scans to detect diseases or abnormalities.
Clinical Decision Support
Systems that recommend diagnoses, treatments, or care pathways based on patient data.
Mental Health AI
Chatbots and apps for mental health screening, therapy support, or crisis intervention.
Drug Discovery AI
AI used in pharmaceutical research, clinical trial design, and drug development.
Understanding the Dual Compliance Path
Healthcare AI compliance requires understanding how multiple regulations interact.
Medical Device Regulation (MDR)
Most healthcare AI qualifies as a medical device under EU MDR 2017/745. The AI Act adds AI-specific requirements on top.
Dual Compliance Pathway
If your AI is a medical device, it's automatically high-risk under AI Act Article 6(1). Both regulations apply.
Notified Body Involvement
High-risk healthcare AI requires conformity assessment, often involving a Notified Body for both MDR and AI Act.
Built for Healthcare Complexity
Klarvo understands that healthcare AI compliance isn't just about the AI Act. Our platform helps you document compliance across multiple regulatory frameworks.
Extended Timeline Note
Healthcare AI that's part of a medical device (Annex I) may have until August 2, 2027 for full compliance—but don't wait. Building documentation now means less scramble later.
Healthcare Compliance GuidePatient Safety Starts With Compliance
Healthcare AI has the potential to save lives—but only if deployed safely and responsibly. Start your compliance journey today.