Article 80 · Chapter IX: Post-Market Monitoring, Information Sharing and Market Surveillance
Procedure for Dealing with AI Systems Classified by the Provider as Non-High-Risk in Application of Annex III
High risk
Summary
If a market surveillance authority concludes a provider has incorrectly classified an Annex III system as non-high-risk under Article 6(3), it requires the provider to take corrective action — re-classify, comply with high-risk obligations, or withdraw.
Key obligations
- Document the rationale for any Article 6(3) non-high-risk claim
- Comply on order with re-classification or withdrawal