Chapter IX
Article 78
Compliant AI Systems which Present a Risk
Plain-Language Summary
Addresses situations where a technically compliant high-risk AI system nevertheless presents an unacceptable risk to health, safety or fundamental rights. Authorities may require corrective action or withdrawal even for CE-marked systems.
Keywords
compliant systemsriskfundamental rightshealthsafetywithdrawalCE marking
Legal Text
Article 78 — Compliant AI Systems which Present a Risk Where a market surveillance authority of a Member State finds that a high-risk AI system which is in compliance with this Regulation presents a risk to the health or safety of persons or to the compliance with obligations under Union or national law intended to protect fundamental rights, it shall require the relevant operator to take all appropriate measures to ensure that the AI system concerned, when placed on the market or put into service, no longer presents that risk.