Non-High-Risk Documentation

Art. 6(4) – Documentation Obligation

A provider that classifies an Annex III system as non-high-risk must document this assessment before placing it on the market and make it available to the competent authority upon request.

Requirements for a Non-High-Risk Classification

All three conditions must be met cumulatively (Art. 6(3)):

1. The AI system does not perform profiling of natural persons
2. The AI system does not make autonomous decisions that significantly affect fundamental rights
3. The AI system has a narrow, preparatory scope of tasks (preparation for human decision-making, not a substitute)

Profiling = always high-risk

If an Annex III system performs profiling (automated processing of personal data to evaluate personal aspects such as work performance, economic situation, health, interests, behaviour), the exception does not apply.

Documentation Content

The non-high-risk assessment must contain at least:

• Unique identification of the AI system
• Assignment to the Annex III category
• Description of the intended purpose
• Justification as to why none of the three conditions is violated
• Date and responsible person
• Version control for amendments

See: Non-High-Risk Assessment Template

Registration Obligation

Even where a system is classified as non-high-risk, there is a registration obligation in the EU database (Art. 49(2)).