Article 48 — CE Marking

WHAT THE ARTICLE IS ABOUT

The visible compliance symbol on every high-risk AI system

Article 48 establishes the CE marking obligation for high-risk AI systems. The CE mark — Conformité Européenne — is the EU’s standardised symbol indicating that a product has been assessed and found to comply with all applicable EU legislation. For AI systems it carries the same legal weight as it does for medical devices, machinery, or toys.

WHAT IT SAYS

Mandatory, visible, and subject to strict rules on use

• High-risk AI systems must bear the CE marking before being placed on the market or put into service
• The CE marking must be affixed visibly, legibly and indelibly to the AI system itself — or where that is not possible, on its packaging or accompanying documentation
• Only providers who have completed the required conformity assessment procedure and drawn up an EU declaration of conformity may affix the CE marking
• The CE marking must be affixed before the system is placed on the market — it cannot be added after the fact
• Where a high-risk AI system is also subject to other EU legislation requiring CE marking, a single CE marking covers all applicable legislation
• Affixing the CE marking falsely — on a system that has not undergone the required conformity assessment — is itself a compliance violation subject to penalties
• Member states may not prohibit, restrict or impede the placing on the market of high-risk AI systems that correctly bear the CE marking

WHO IS AFFECTED

All providers of high-risk AI systems before market placement

• All providers of high-risk AI systems — CE marking is mandatory before market placement
• Importers and distributors who must verify CE marking exists before placing systems on the market or making them available
• Market surveillance authorities who enforce CE marking requirements
• Providers of products embedding high-risk AI systems as safety components — one CE marking covers both the product and the AI

WHAT IT MEANS FOR SMES

CE marking is the capstone of the compliance process — not the start

• The CE marking is the last step of compliance, not the first — you cannot affix it until the conformity assessment is complete and the EU declaration of conformity is drawn up
• Think of CE marking as your public commitment: by affixing it you declare to every importer, distributor, deployer and regulator that your system has met all applicable requirements
• False or premature CE marking — affixing it before completing the assessment — creates direct legal liability and may trigger market surveillance action
• If your high-risk AI system is embedded in a product that already requires CE marking under another EU regulation, your single CE mark covers both — avoid duplicating the marking
• Digitally delivered AI systems where no physical product exists present a practical challenge for CE marking — in these cases the marking typically appears in the documentation and any user interface elements rather than physical packaging

Related Articles

• Article 43 — Conformity assessment (must be completed before CE marking can be affixed)
• Article 47 — EU declaration of conformity (must be drawn up alongside CE marking)
• Article 16 — Provider obligations (affixing CE marking is one of the twelve mandatory obligations)
• Article 49 — Registration (must also be completed before market placement)