Section 5: Standards, Conformity Assessment, Certificates and Registration

What this part of the EU AI Act covers

Section 5 covers the route to market. It provides for harmonised standards and common specifications, presumption of conformity, the conformity assessment procedures themselves, the EU declaration of conformity, CE marking, and registration in the EU database before a high-risk system is placed on the market.

It binds providers, and it is the gate between a compliant build and lawful placing on the market. Applying harmonised standards in full gives a presumption of conformity and, for most Annex III systems, opens the internal-control route rather than requiring a notified body.