CE Marking (EU AI Act)
Art. 48 EU AI Act — the conformity marking
TL;DR
CE marking is mandatory for high-risk AI systems under Art. 48 EU AI Act. It is affixed by the provider and is based on a successful conformity assessment (Art. 43).
What is CE marking under the EU AI Act?
Mandatory elements of CE marking (Art. 48):
- The CE logo visible on the product (or digitally where the product is not physical)
- The EU declaration of conformity (Art. 47)
- For high-risk AI in regulated products (machinery, medical devices): the Annex I obligations apply in addition (EU harmonisation legislation)
- Where a notified body is involved: that body's identification number
Germany and Austria: The AI Act is a directly applicable EU regulation. The rules on CE marking apply equally in Germany and Austria (Regulation (EU) 2024/1689); there are no diverging national provisions in this respect.
Practical example
The manufacturer of AI-driven medical diagnostic software goes through a conformity assessment with a notified body (NB-XXXX). The CE marking with the notified body number is affixed to the software splash screen and to the packaging.
Frequently asked questions
Does CE marking also apply to software?
Yes. For non-physical products: a digital CE marking within the software (for example on the about screen).
Who is liable for incorrect CE marking?
The provider (Art. 16). Breaches of provider obligations (including CE marking) fall under Art. 99(4): a fine of up to EUR 15 million or 3 % of worldwide annual turnover. The EUR 35 million / 7% tier (Art. 99(3)) applies exclusively to the prohibited practices under Art. 5.
How long does CE marking remain valid?
As long as no substantial modifications are made. Where there is a substantial modification: a new assessment.
See also
Practitioner note: This article is practice-oriented compliance documentation, not legal advice. We are compliance specialists, not a law firm. For legally binding advice, consult an admitted lawyer.