Can your system be classified as Artificial Intelligence?
According to Art. 3(1), an AI system is automated, operates with varying levels of autonomy, can adapt after deployment, and generates outputs (predictions, content, recommendations, or decisions) that influence physical or virtual environments.
What is your role with respect to the AI system?
The role determines specific obligations according to the AI Act. Providers and Deployers have the greatest responsibilities. Art. 22-23: Extra-EU Providers must appoint an Authorised Representative.
⚠️ DEPLOYER - FRIA Note: If you are a deployer and the system is high-risk, you may need to perform a Fundamental Rights Impact Assessment (Art. 27) if you are: public entity, essential public services provider, banking/insurance.
Does the system fall under a PROHIBITED practice?
Art. 5 prohibits 8 categories of unacceptable AI systems. Ban effective from February 2, 2025. Penalties up to 35M EUR or 7% turnover.
Is it a General Purpose AI model (GPAI)?
GPAI models (Art. 51-56) have general capabilities and can be used for multiple purposes. Obligations from August 2, 2025. ATTENTION: A GPAI can ALSO be a component of regulated or high-risk systems.
Is it a safety component of regulated products?
Annex I lists products subject to EU legislation where AI could be a critical safety component. Complete list compliant with AI Act.
Does the system operate in one of the 8 high-risk areas?
Annex III identifies 8 areas where AI systems are high-risk for fundamental rights and safety.
Does it require specific transparency obligations?
Some systems must inform users of their artificial nature (Art. 50).
Where will the system be used or marketed?
AI Act applies to systems used in the EU or whose output is used in the EU, regardless of where they are developed.