CE Marking

CE marking (from the French "Conformite Europeenne") is a mandatory certification mark for products sold within the European Economic Area, indicating that a product conforms to applicable EU legislation. For AI systems regulated under the EU AI Act, CE marking signifies that a high-risk AI system has undergone the required conformity assessment procedures and meets all applicable requirements for safety, fundamental rights protection, and transparency. The CE mark is the visible symbol that allows an AI system to be legally placed on the EU market or put into service.

CE marking has long been familiar in product safety domains such as machinery, medical devices, and electronics. Its extension to software-based AI systems represents a significant expansion of the product conformity framework into a new domain. For high-risk AI systems under the EU AI Act, CE marking is not optional; it is a legal prerequisite for market placement. Unlike some regulatory frameworks where compliance is enforced primarily through post-market penalties, the EU AI Act requires upfront demonstration of conformity before an AI system can be legally deployed. This makes CE marking the gate that determines whether an AI system can enter the EU market at all.

For most high-risk AI systems, CE marking is achieved through self-certification: the provider conducts an internal conformity assessment, compiles the required technical documentation (Annex IV), implements the required quality management system, draws up the EU Declaration of Conformity, and affixes the CE marking. The provider takes legal responsibility for the accuracy of this self-assessment. However, certain AI systems require third-party assessment by a Notified Body before CE marking can be applied. Under the EU AI Act, third-party assessment is required for real-time remote biometric identification systems used in publicly accessible spaces for law enforcement, and AI systems intended to be used as safety components of products covered by certain Union harmonisation legislation (where third-party assessment was already required). When a Notified Body is involved, the assessment process is more rigorous and the marking cannot be applied until the Notified Body issues its conformity certificate.

Organizations preparing for CE marking should begin by completing their conformity assessment, which requires fully implementing the requirements of Articles 8 through 15 for high-risk systems. This includes establishing a risk management system, ensuring data governance, completing technical documentation per Annex IV, implementing logging and traceability, enabling human oversight, and achieving required accuracy and robustness standards. Once conformity assessment is complete, the provider issues a Declaration of Conformity and applies the CE marking. Importantly, CE marking is not a one-time event; providers must maintain compliance throughout the AI system's lifecycle and update their conformity assessment if substantial modifications are made.