Article 43 requires providers of high-risk AI systems to undergo a conformity assessment before placing their system on the EU market. Systems that pass receive CE marking.
Conformity assessment routes
- Internal control (Annex VI) — Self-assessment by the provider. Available for most high-risk AI systems.
- Third-party assessment (Annex VII) — Assessed by a notified body. Required for biometric identification systems and some other categories.
Tracking in Venvera
Go to AI Act → Conformity & CE. For each AI system, record:
| Field | Description |
|---|---|
| AI System | Which system is being assessed |
| Assessment Type | Internal control or Third-party |
| Notified Body | Name of the notified body (if third-party) |
| Assessment Date | When the assessment was conducted |
| Result | Pass or Fail |
| CE Marked | Whether CE marking has been applied |
| Expiry Date | When the conformity assessment expires |
CE marking must be visible, legible, and indelible on the AI system or its packaging. It is a legal requirement before placing high-risk AI systems on the EU market.