Role & scope
- Clarify whether you act as provider, deployer, distributor, etc.
- Map the AI system to the main AI Act obligations (high-level)
- Identify cross‑regulation overlaps (e.g., MDR/IVDR)
Practical guidance for AI providers and deployers under the EU AI Act — including documentation readiness, risk classification support, and EU representation considerations for non‑EU companies.
The EU AI Act (Regulation (EU) 2024/1689) introduces obligations for providers and deployers of AI systems and certain AI models. Applicability depends on your role (provider/deployer/importer/distributor) and on the AI system category (e.g., high-risk).
If AI is used in or with medical devices, MDR/IVDR obligations may also apply in parallel.
Send a short description of your AI product, target markets, and your role (provider/deployer) — we’ll confirm the likely scope and next steps.