Purpose, provider, version, interfaces and instructions.
NELSIA · Annex IV
The Technical File should follow the system.Not live in a disconnected folder.
NELSIA links Annex IV documentation blocks to the actual versions, tests, risks, human reviews, changes and post-market evidence of the AI system.
Nine blocks · explicit mapping
Methods, design, data, validation, testing and cybersecurity.
Capabilities, limitations, foreseeable risks and human oversight.
Why the selected metrics fit the intended system.
Detailed risk-management system and related evidence.
Relevant system changes preserved by version.
Applied standards or alternative technical solutions.
Controlled reference to the signed declaration where applicable.
Monitoring system, plan, incidents and observed performance.
Official source: Regulation (EU) 2024/1689 — Annex IV.
Boundary
Document coverage is not the same as certified conformity.
NELSIA structures versions, evidence and review. Final legal qualification, conformity assessment, notified-body intervention and the EU declaration remain with the competent actors when the legal framework requires them.