Glossary term
Glossary term
Governance and Compliance
A conformity mark indicating that a product or system meets applicable EU requirements before being placed on the market. For AI-enabled products, CE marking should be backed by technical documentation and conformity evidence. The mark is not the evidence itself; the evidence sits in the quality system, technical documentation, risk management file, and post-market monitoring records.
EU AI Act Article 48 requires CE marking on high-risk AI systems to be affixed visibly, legibly, and indelibly, with the Notified Body number where applicable.
A high-risk AI system embedded in a CE-marked medical device must satisfy both MDR and EU AI Act requirements for CE marking.
Misuse of CE marking is enforceable under Article 99 with penalties under national law, similar to other Single Market product law.