Digital Lexicon Hub

An AI system that the EU AI Act classifies as posing significant risk to health, safety or fundamental rights, which triggers strict obligations.

If a product or internal tool falls into a high-risk category, such as CV screening or credit scoring, providers face conformity assessment and documentation duties, and deployers must ensure human oversight, log retention and trained staff.

An HR software vendor maps its candidate-ranking feature to the Annex III employment area, opens a risk management file, documents training data quality checks, adds activity logging and drafts instructions for deployers on human oversight.

Classification depends on intended purpose, so the same model can be high-risk in one use and not in another. The Article 6(3) exemption needs a documented assessment and never covers profiling, and the Digital Omnibus moved the application dates.

Article 6 sets two routes: AI that is a safety component of, or is itself, a product under Annex I legislation requiring third-party conformity assessment, and systems listed in Annex III, such as employment, education, essential services and biometrics. Providers must meet requirements on risk management, data quality, logging, documentation, transparency, human oversight, accuracy and cybersecurity. Under the amended EU AI Act, Annex III duties apply from 2 December 2027. Some deployers must also complete a Fundamental Rights Impact Assessment (FRIA).