Chapter IIIHigh-Risk
Article 48
CE Marking of Conformity
Plain-Language Summary
Requires providers to affix the CE marking to high-risk AI systems before placing them on the EU market. The CE marking must follow the general principles in Regulation (EC) No 765/2008 and must be visible, legible, and indelible.
Keywords
CE markingconformityprovidermarket placementRegulation 765/2008notified body ID
Legal Text
Article 48 — CE Marking of Conformity 1. The CE marking of conformity shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008. 2. For high-risk AI systems provided digitally, a digital CE marking shall be used, only where it can be easily accessible via the interface from which that system is accessed or via an easily accessible link. 3. The CE marking shall be affixed visibly, legibly and indelibly for high-risk AI systems. Where that is not possible or not warranted on account of the nature of the high-risk AI system, it shall be affixed to the packaging or to the accompanying documentation, as appropriate. 4. Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 43.