Full definition
The EU AI Act (Regulation 2024/1689) is the world's first comprehensive AI regulation. Phased entry into force from August 2024 through 2027. Risk-based classification: prohibited (social scoring, biometric surveillance, etc.), high-risk (healthcare AI, education, employment, critical infrastructure), limited-risk (transparency obligations like chatbot disclosure), and minimal-risk (most consumer AI).
For healthcare specifically: most clinical AI falls under high-risk. Requirements include conformity assessment before market entry, technical documentation, risk management system, data governance, human oversight, transparency, accuracy/robustness validation, and post-market monitoring. EU AI Act compliance interacts with EU MDR (which already regulates SaMD); both apply.
For MOVO-X procurement in EU: AI features fall predominantly in high-risk category. We document the AI Act conformity posture per feature including risk management, data governance, and human-oversight design.
Where eu ai act is used
- EU healthcare AI deployments
- Clinical decision-support
- Diagnostic AI
- Patient-flow optimisation AI
- Risk-stratification systems
Types of eu ai act
Prohibited
Social scoring, predictive policing, real-time biometric surveillance (with narrow exceptions), etc.
High-risk
Healthcare, education, employment, critical infrastructure, law enforcement, etc. Most healthcare AI lands here.
Limited-risk
Chatbots, deepfakes — transparency obligation.
Minimal-risk
Most consumer AI — no specific obligations.
General-purpose AI
Foundation models — separate transparency + safety obligations.
Quantified benefits
- ▸Patient safety in AI healthcare deployments
- ▸Harmonised AI regulation across EU/EEA
- ▸Mandatory transparency to clinicians and patients
- ▸Post-market monitoring obligation
Frequently asked
Is healthcare AI subject to the EU AI Act?+
Yes — most clinical AI falls under the high-risk category, subject to conformity assessment, technical documentation, human oversight, and post-market monitoring obligations.
When does the EU AI Act take effect?+
Phased entry into force from August 2024. Prohibited practices banned February 2025. General-purpose AI rules August 2025. Most high-risk obligations August 2026. Some healthcare AI obligations August 2027.
How does EU AI Act interact with MDR?+
Both apply. MDR for medical-device classification and CE marking; AI Act for AI-specific requirements. Healthcare AI vendors demonstrate compliance with both.
How does MOVO-X handle the EU AI Act?+
AI features classified by AI Act risk tier. High-risk features documented with risk management, data governance, accuracy validation, human-oversight design, and post-market monitoring framework.