EU AI Act Compliance Assessment

Evaluate compliance with EU Artificial Intelligence Act for high-risk AI systems, covering risk management, data governance, transparency, human oversight, and conformity assessment

TechnologyMedtechHealthcareAll25 minutes15 questions

1. Risk Classification

Have you classified your AI system per Annex III (high-risk systems)?*

High-risk: safety components of products, biometric ID, critical infrastructure, employment, credit scoring, law enforcement, migration, justice

If your AI is used in medical devices, is it classified per MDR/IVDR?*

AI as safety-critical component or intended purpose triggers high-risk classification

2. Risk Management System

Is a risk management system established per Article 9?*

Continuous process to identify, analyze, evaluate, mitigate AI-specific risks

Are foreseeable risks to health, safety, fundamental rights assessed?*

Risks: bias, discrimination, safety failures, security vulnerabilities

Are risk mitigation measures implemented and effectiveness validated?*

Article 9(4): Risk controls tested throughout AI system lifecycle

3. Data Governance

Are training/validation/test datasets relevant, representative, and error-free?*

Article 10: Data quality essential for AI performance and safety

Have biases in datasets been examined and addressed?*

Article 10(2)(f): Detect and mitigate bias in protected characteristics

Are data governance and management practices documented?*

Article 10(3): Document data provenance, quality, preprocessing, curation

4. Transparency & Documentation

Is technical documentation created per Annex IV?*

Comprehensive documentation: design, development, performance, risk management

Are instructions for use provided describing AI capabilities and limitations?*

Article 13: IFU for deployers explaining intended use, performance, risks

Are users informed they are interacting with an AI system?*

Article 52: Transparency obligation for AI interaction

5. Human Oversight

Are human oversight measures implemented per Article 14?*

Human-in-the-loop, on-the-loop, or in-command mechanisms

Can humans override or intervene in AI system decisions?*

Article 14(4)(c): Stop button, ability to disregard/reverse AI output

6. Conformity Assessment

Have you conducted conformity assessment per Article 43?*

Internal control or third-party assessment depending on AI system type

Is the AI system CE marked and registered in EU database?*

Article 49: CE marking and registration required before market placement

Please answer all required questions to see your results