The EU stamp of approval that a high-risk AI product carries to show it has passed all required safety and compliance checks.
The EU stamp of approval that a high-risk AI product carries to show it has passed all required safety and compliance checks.
Under Article 48 of the EU AI Act, high-risk AI systems must bear the CE marking before being placed on the EU market or put into service. The CE marking must be affixed visibly, legibly, and indelibly to the AI system or its documentation. Where a system is embedded in a product regulated by other EU legislation (e.g. medical devices), the CE marking process is coordinated. The marking is not a quality award or endorsement — it is a declaration by the provider that legal requirements have been met. Affixing CE marking falsely is subject to enforcement by market-surveillance authorities.
Product managers must treat CE marking as a precondition for EU launch timelines; it cannot be obtained retroactively and must be maintained through post-market monitoring.
Just as electrical goods must carry CE marking to be sold in Europe — confirming they meet safety standards — high-risk AI systems carry CE marking to confirm regulatory compliance.
The EU stamp of approval that a high-risk AI product carries to show it has passed all required safety and compliance checks.
Under Article 48 of the EU AI Act, high-risk AI systems must bear the CE marking before being placed on the EU market or put into service. The CE marking must be affixed visibly, legibly, and indelibly to the AI system or its documentation. Where a system is embedded in a product regulated by other EU legislation (e.g. medical devices), the CE marking process is coordinated. The marking is not a quality award or endorsement — it is a declaration by the provider that legal requirements have been met. Affixing CE marking falsely is subject to enforcement by market-surveillance authorities.
Product managers must treat CE marking as a precondition for EU launch timelines; it cannot be obtained retroactively and must be maintained through post-market monitoring.