Article 11: Technical Documentation (Annex IV)
Article 11 requires high-risk AI providers to draw up comprehensive Annex IV technical documentation before placing an AI system on the market and keep it updated for 10 years.
Binding European Union legislative enactment across all 27 Member States.
Calculated on consolidated global group turnover under Article 71 formulas.
Requires specialized corporate tech E&O riders for regulatory defense.
Codified Statutory Requirements & Clauses
Detailed clause-by-clause legal and engineering specifications under Article 11.
General description of AI system, instructions for use, model architecture, computational logic, data structures, and hardware requirements.
Detailed description of development methodology, training datasets, pre-processing, validation metrics, and cybersecurity protections.
Documentation of the quality management system, post-market monitoring plan, and conformity assessment certificate.
Article 11 Technical Compliance Protocol
Complete this operational verification protocol to ensure engineering and organizational alignment with Article 11.