CE Marking (EU AI Act)
Article 49 EU AI Act — conformity marking
Practitioner's note: This article is practice-oriented compliance documentation, not legal advice. We are a compliance specialist, not a law firm. For legally binding information please consult a licensed lawyer.
TL;DR
CE marking is mandatory for high-risk AI systems under Article 49 EU AI Act. It is affixed by the provider and based on a successful conformity assessment (Article 43).
What is CE Marking (EU AI Act)?
CE mandatory contents (Article 49):
- CE logo visible on the product (or digital if non-physical)
- EU declaration of conformity (Article 47)
- For high-risk AI in regulated products (machinery, medical devices): additional Annex II obligations
- Where a notified body is involved: identification number of the notified body
Practical example
A manufacturer of an AI-driven medical diagnostic software undergoes a conformity assessment with a notified body (NB-XXXX). The CE marking with the NB number is affixed on the software splash screen and packaging.
Frequently asked questions
Does CE marking also apply to software?
Yes. For non-physical products: digital CE marking in the software (e.g. About screen).
Who is liable for incorrect CE marking?
The provider (Article 16). Fine under Article 99 of up to EUR 35 million / 7%.
How long does CE marking remain valid?
As long as no substantial modifications occur. In the event of a substantial modification: new assessment.