AI compliance & EU AI Act
Assess risk classes, meet documentation duties, stay compliant — pragmatic rather than bureaucratic.
The has been in force since 2024. The first prohibitions apply from February 2025, the duties for high-risk systems from August 2026. Anyone deploying or developing needs to classify their systems — and know which duties concretely follow.
is more than just the : GDPR remains applicable in parallel, industry-specific regulations (BaFin/, , healthcare) stack on top, copyright and liability questions too. Treating these in separate departments creates duplicate work and gaps at the same time.
The goal isn't a 200-page manual no one reads. The goal is a pragmatic framework that gets built into existing processes — templates, checklists, clearly assigned responsibilities and a risk register that actually gets maintained.
Inventory
inventory incl. , data flows, responsibilities — as an record of processing.
Risk classification
Prohibited, high-risk, limited, minimal — documented per system with reasoning.
Gap analysis
Thinking + GDPR + industry rules together. Gap list with effort and priority.
framework
Policy, onboarding checklist, templates, roles, audit trail — built in pragmatically.
Training & upkeep
Staff awareness, update discipline, semi-annual self-check, incident process.
Inventory
inventory incl. , data flows, responsibilities — as an record of processing.
Risk classification
Prohibited, high-risk, limited, minimal — documented per system with reasoning.
Gap analysis
Thinking + GDPR + industry rules together. Gap list with effort and priority.
framework
Policy, onboarding checklist, templates, roles, audit trail — built in pragmatically.
Training & upkeep
Staff awareness, update discipline, semi-annual self-check, incident process.
From AI Act status quo to a pragmatic compliance framework
Risk classification under the AI Act
ProhibitedHigh-riskLimitedMinimalThe AI Act works with four risk classes. The higher the risk, the stricter the duties — and the more expensive non-compliance becomes. Every system from the inventory gets assigned to a class.
The four tiers:
- Prohibited — social scoring, manipulative AI, real-time facial recognition in public spaces (with narrow exceptions), emotion recognition at work or in education. These practices have been banned since February 2025 — anyone using them must stop immediately.
- High-risk — AI in hiring, credit scoring, education decisions, law enforcement, migration control, critical infrastructure. The strictest duties apply here: conformity assessment, technical documentation, risk management, human oversight, logging, high data quality. Duties apply from August 2026.
- Limited risk — chatbots, deepfakes, AI-generated content. The duty: transparency. Users must know they are interacting with AI or seeing AI-generated content.
- Minimal risk — everything else (spam filters, recommender systems, AI autocomplete). No specific duties from the AI Act, but GDPR and other regulations continue to apply.
Special case: General Purpose AI (GPAI):
- Models like GPT-4 or Claude have their own duties from August 2025
- Mainly affects providers, not users — but anyone fine-tuning and distributing their own models can fall under this
The classification is documented per system, with reasoning. This isn't an Excel exercise — in an audit, this reasoning is the first thing asked for.
Gap analysis — what's missing for compliance?
GDPRFrom the inventory and classification, a set of duties emerges per system. Now we compare what is already in place and what is missing — the classic gap analysis, applied to AI.
AI Act requirements per risk class:
- Technical documentation (what does the system do, trained on which data, with which limits)
- Risk management system (ongoing, not one-off)
- Data governance (representativeness, bias checks, data provenance)
- Logging and record-keeping duties (for high-risk systems)
- Human oversight with clearly defined intervention points
- Transparency and informing the people affected
- Cybersecurity and robustness
GDPR overlap:
- Legal basis for every processing — especially interesting for AI training data
- DPIA at high risk, especially with profiling or automated decisions (Art. 22 GDPR)
- DPA with every external AI processor that handles personal data
- Document TOMs — encryption, access control, deletion concept, backups
- Update the record of processing — enter AI processing cleanly
- Check third-country transfers — Schrems II, Standard Contractual Clauses, Transfer Impact Assessment if needed
Industry-specific regulations:
- Banks & financial services — MaRisk, BAIT, BAIT outsourcing module, MiFID II for investment recommendations
- Healthcare professions — confidentiality (§ 203 StGB), patient data protection, MPG/MDR for medical devices
- Law firms — professional secrecy, client protection, BRAO
- KRITIS — extended IT security and reporting duties, penetration tests, contingency plans
From the comparison comes a concrete gap list per system: what's missing (documentation, process, technical measure), who's responsible, by when it must be in place, what it costs. Not a blanket “everything must be compliant” list, but prioritised by risk and effort.
Compliance framework — templates, roles, processes
PragmaticReusableFrom the gap list, a framework emerges that gets built into existing structures — not a parallel universe of forms. Compliance no one uses is worse than no compliance.
What's in the framework:
- AI policy — one page on what staff may and may not do (e.g. no customer data into public ChatGPT, no code into external APIs without approval)
- Onboarding checklist for new AI tools — risk classification, DPIA check, DPA question, data flow sketch, approval workflow
- Templates — technical documentation, risk assessment, DPIA, DPA addendum for AI specifics, training data provenance
- Roles and responsibilities — who is the AI officer? Who decides on approvals? Who reviews technical documentation?
- Audit trail — where are decisions recorded? How long are logs kept?
- Escalation and incidents — what to do in case of a data leak, bias incident, complaint?
Self-hosted as a compliance lever — where it fits:
- For particularly sensitive data, use local models (e.g. Ollama with Gemma) — no third-country transfer, no Schrems II risk
- Self-hosted stack for law firms, practices, public bodies, KRITIS operators — quality below frontier models, but auditable locally
- Hybrid architecture: non-critical tasks in the cloud, sensitive routines local — a pragmatic middle path that works for most SMBs
The framework grows with the company. First AI tool: one-page policy + one entry in the record of processing. Ten tools later: same framework, just extended. Templates and processes stay the same.
Training & ongoing upkeep
StaffUpdatesAuditsCompliance isn't a project you close out — it's an ongoing state. Once the framework is in place, it's about staff training, update discipline and regular review.
Training — on two levels:
- General awareness for all employees — what is AI, what may I do, what not, how do I spot problematic tools, who do I report incidents to?
- In-depth training for responsible roles — data protection officers, AI officers, IT leads. Risk classification, DPIA, technical requirements
Update discipline:
- When a new AI tool is introduced, it runs through the onboarding checklist — no exceptions
- For larger model updates (e.g. new model provider, new training data set), the risk assessment is updated
- Legal updates (new AI Act guidelines, BaFin notices) are folded into the framework — quarterly check
Regular audits — internal and external:
- Semi-annual internal self-check against your own checklist — what has changed, what's new, where are the gaps?
- External audits in regulated industries (BaFin review, ISO 27001, industry-specific audits) prepared in good time — the documentation is ready instead of being scrambled together under audit pressure
- Penetration tests for AI systems with an external interface — prompt injection, jailbreaking, data extraction
What happens on incidents:
- A clearly defined reporting path within 72 hours for reportable data breaches (Art. 33 GDPR)
- Incident documentation, root cause analysis, corrective measures — reviewed in audits
- Lessons learned flow back into the framework
With this ongoing upkeep, compliance turns from a costly risk factor into a competitive advantage — B2B customers, insurers and funding applications increasingly ask for solid AI compliance.
Sounds interesting?
Let's talk it through in a free intro call and see how this would work for you.