Annex IV technical documentation
Providers of high-risk systems must prepare technical documentation before placing the system on the market and keep it up to date (Art. 11). SMEs, including start-ups, may provide it in a simplified way using a form the Commission will publish.
Annex IV headings
- General description of the AI system (intended purpose, versions, interactions, hardware, UI, instructions for use)
- Detailed description of the elements and the development process (methods, design choices, architecture, data, human oversight, validation and testing, cybersecurity)
- Monitoring, functioning and control (capabilities, limitations, accuracy)
- Appropriateness of the performance metrics
- Risk management system (Art. 9)
- Relevant changes over the lifecycle
- Harmonised standards applied
- EU declaration of conformity
- Post-market monitoring plan (Art. 72)
Our paid pack generates this skeleton pre-filled from your answers.
Not legal advice. Last reviewed 26 Oct 2026.