CE Marking Under the EU AI Act (Article 48): What It Means for High-Risk AI
CE marking under EU AI Act Article 48 signals a high-risk AI system's conformity. It is affixed after the conformity assessment and Declaration.
The CE marking that already appears on regulated products now extends to high-risk AI. Under Article 48 of the EU AI Act, Regulation (EU) 2024/1689, a provider affixes the CE marking to a high-risk AI system to indicate it conforms with the Act. It is the last visible step, not the first — it comes after the work, not instead of it.
What CE marking signals
CE marking is a declaration that the system meets the applicable EU requirements and may be placed on the EU market. For a high-risk AI system, affixing it means the provider has run the conformity assessment (Article 43), compiled the technical documentation (Article 11, Annex IV), and drawn up the Declaration of Conformity (Article 47). The marking is the outward sign of that completed process — you cannot lawfully affix it first and do the work later.
How it is affixed
The CE marking must be affixed visibly, legibly and indelibly to the high-risk AI system, or — where that is not possible or warranted given the nature of the system — to its packaging or accompanying documentation. Because many AI systems are software, the Act allows a digital CE marking. Where a notified body was involved (the Annex VII route for biometrics), its identification number accompanies the marking.
The sequence to remember
CE marking sits in a fixed order: classify (Article 6) → meet the requirements (Articles 9–15) → assess conformity (Article 43) → draw up the Declaration (Article 47) → affix CE marking (Article 48) → register (Article 49) → place on the market. Getting the order right matters: registration and market placement come after the marking, and the marking comes after the Declaration.
Not the only CE regime
For product-embedded AI (Annex I — medical devices, machinery, vehicles), CE marking runs through the sectoral legislation, integrated with the existing product conformity, rather than a separate AI Act marking. A medical-device AI carries its MDR CE marking, reflecting the AI Act requirements through the integrated route. Don't double-mark; follow the product route where it applies.
How Confir helps
Confir sequences the steps so the CE marking reflects a completed conformity assessment and Declaration of Conformity rather than an aspiration — assembling the Annex IV documentation, tracking the Articles 9–15 evidence, and generating the Declaration that the marking attests to. The engine is deterministic and rule-based, with an audit trail of each step.
Frequently asked questions
What does CE marking mean under the EU AI Act?
Under Article 48, CE marking on a high-risk AI system indicates that its provider has demonstrated conformity with the Act and may place it on the EU market. It is affixed after the conformity assessment (Article 43) and the Declaration of Conformity (Article 47), not before.
Can software carry a CE marking?
Yes. Because many AI systems are software, the Act allows a digital CE marking. The marking must be visible, legible and indelible, affixed to the system or, where appropriate, to its packaging or accompanying documentation.
When is a notified body number shown with the marking?
Where a notified body was involved in the conformity assessment — the Annex VII route, used for Annex III point 1 biometrics without harmonised standards — its identification number accompanies the CE marking. Most Annex III systems use internal self-assessment and carry no notified-body number.
Do product-embedded AI systems get a separate AI Act CE marking?
No. Annex I product-embedded AI runs CE marking through its sectoral legislation (e.g. MDR for medical devices), integrated with the existing product conformity, rather than a separate AI Act marking. Follow the product route where it applies.
When does the CE marking obligation apply?
It attaches to high-risk systems. Stand-alone high-risk Annex III obligations apply from 2 December 2027, under the Digital Omnibus deferral, now adopted (European Parliament, 16 June 2026; Council, 29 June 2026), pending only Official Journal publication expected before 2 August 2026.
Related guides
- EU Declaration of Conformity
- Conformity assessment checklist
- EU database registration
- Annex III high-risk use cases
- How AI risk classification works
Manage your EU AI Act compliance in one place
Confir automates risk classification, technical documentation, and audit trails for any company. No consultants. No 6-month projects. 14-day free trial.
Start free trial →