Risk management system
Continuously documented risk management system across the entire lifecycle of the AI system.
EU AI Act · Art. 9–14 AI Regulation
AI Governance Infrastructure for the EU AI Act — making high-risk AI verifiable
The AI Regulation (EU) 2024/1689 has been in force since August 2024. Financial institutions that deploy or develop high-risk AI systems must demonstrate full compliance to BaFin, EBA and the EU AI Office by 2026 — not merely assert it. With EVIDION, you build the AI Governance Infrastructure that proves compliance.
What the EU AI Act requires of high-risk systems
Art. 9–14 of the AI Regulation define the framework of requirements for high-risk AI in the financial sector. Each requirement must not only be met — but documented in a demonstrable way at any time.
Data & data governance
Evidence-obligated data quality, bias analysis and data governance for training, validation and testing.
Technical documentation
Complete technical documentation before market placement — with version history and change evidence.
Logging & record-keeping
Automatic logging of all system outputs and decision paths for traceability by third parties.
Transparency & information
Comprehensible information obligations toward users: capabilities, limitations and oversight mechanisms.
Human oversight
Documented Human-in-the-Loop: intervention options, override protocols, oversight responsibility.
Why compliance alone is not enough — evidence as the differentiator
BaFin, EBA and the EU AI Office expect not only the existence of governance structures — but their complete, always-retrievable demonstrability. IDW EPS 528 sets the new audit standard for AI systems in the financial sector.
“Can you demonstrate without gaps, for each of your high-risk AI systems, that human oversight (Art. 14), complete logging (Art. 12) and an active risk management system (Art. 9) are in place in operation?”
ISO/IEC 42001 certification path
EVIDION structures your AI governance documentation along the ISO/IEC 42001 framework — the international standard for AI management systems in the financial sector.
EU data sovereignty
All data remains within European infrastructure. ISO 27001 and SOC 2 certified. No transfer outside the EU — a prerequisite for regulatory acceptance.
EVIDION as the AI Assurance Layer for the EU AI Act
EVIDION transfers your existing AI governance documents, model decisions and oversight measures into an audit-proof evidence system — making your high-risk AI supervisory-ready.
Explainability Engine
Decision attribution under Art. 13 AI Act: every AI decision explained and logged traceably.
Risk Evidence Ledger
Complete evidence under Art. 9 & 12 AI Act — SHA-256-signed, immutable, audit-proof.
Human Oversight Interface
Documented Human-in-the-Loop under Art. 14 AI Act with clear oversight responsibility and override protocol.
IDW EPS 528 Assurance Layer
Audit-ready examination trails for auditors under IDW EPS 528 — the new standard for AI audits in the financial sector.
Reference framework & compliance standards
Art. 9–14 AI Act complete all high-risk requirements covered
IDW EPS 528 Assurance standard auditor-ready examination trails
EU AI Office Supervisory authority supervisory-ready from 2026
BaFin & EBA audit standards
EVIDION is aligned with the requirements of BaFin (MaRisk, BAIT) and EBA (EBA/GL/2019/04) — the authoritative supervisory standards for AI in the German and European financial sector.
EVIDION as the “AI Assurance Layer for Europe”
~22,000 EU financial institutions fall under DORA. Every institution that deploys high-risk AI additionally needs EU AI Act compliance. EVIDION is the infrastructure that connects both.
Make high-risk AI supervisory-ready — starting today.
Our team, with experience at UBS, Deutsche Bank and Bank of America, shows you how EVIDION makes your AI governance documentation EU AI Act-compliant and verifiable.