How do conformity assessment and CE marking work for AI?

This applies now

• For this situation, the preparation phase matters most right now.

Coming up

• Articles 43-49: conformity assessment, CE and registrationfrom 2 December 2027
• Annex III: high-risk AIfrom 2 December 2027

High-risk AI undergoes a conformity assessment before market placement and then carries a CE marking. For most Annex III systems this runs via the provider’s internal control; for certain biometrics and for AI in regulated products a notified body is involved. The duty follows the timeline: Annex III from 2 December 2027, Annex I from 2 August 2028. For buyers: ask your supplier for it.

Your first actions

1. 1Complete the conformity route before market placement. Select the correct assessment procedure, draw up the EU declaration of conformity, affix the CE marking and register in the EU database.
2. 2Classify the use case and document the outcome. Assess Article 5, Article 6 and Annex III in that order and document purpose, context and any Article 6(3) exception.

Record this

• Conformity file
• Article 6 and Annex III classification record