Why You Need Expert Help
- 458 pages of regulation with 180 recitals and 13 annexes
- Risk classification depends on intended purpose, not just technology
- Technical documentation requirements reference 8 separate standards
- Conformity assessment requires third-party audits for certain high-risk systems
- Post-market monitoring obligations continue after deployment
Risk Classification
Art. 6, Annex III
We analyze each AI system against Annex III criteria to determine if it qualifies as high-risk. You get a documented classification decision with legal references.
- Map AI systems to Annex III use cases
- Assess intended purpose and deployment context
- Document classification rationale per Art. 6(2)
- Identify prohibited practices (Art. 5)
- Review GPAI model obligations (Art. 51-56)
Technical Documentation
Art. 11, Annex IV
We build the complete technical file required for high-risk AI systems. This covers all 8 areas of Annex IV - from risk management to cybersecurity.
- Risk management system (Art. 9, ISO 23894)
- Data governance and management practices (Art. 10)
- Technical design and architecture documentation
- Logging and traceability requirements (Art. 12)
- Human oversight measures (Art. 14)
- Accuracy, robustness, and cybersecurity (Art. 15)
Conformity Assessment Prep
Art. 43
We prepare your systems for conformity assessment - whether internal or through a notified body. You enter the audit with documentation complete and gaps closed.
- Gap analysis against harmonized standards
- Internal conformity assessment support (Annex VI)
- Third-party audit preparation (Annex VII)
- EU database registration (Art. 49)
- Post-market monitoring plan (Art. 72)
- Quality management system review (Art. 17)
How We Work
Typical timeline: 2-4 months
Assess
AI system inventory, risk screening, gap analysis
Classify
Risk classification per Art. 6 and Annex III
Document
Technical file, risk management, data governance
Monitor
Post-market monitoring, incident reporting setup
Non-Compliance Penalties
The EU AI Act has the highest penalties of any EU regulation.
EUR 35M or 7%
of global revenue for prohibited AI practices (Art. 5)
EUR 15M or 3%
of global revenue for high-risk violations (Art. 6-49)
EUR 7.5M or 1%
of global revenue for incorrect information to authorities
Frequently Asked Questions
This page provides general information about the EU AI Act (Regulation (EU) 2024/1689). It is not legal advice. Consult qualified legal counsel for binding interpretations.