Annex IV: Technical Documentation Requirements
Annex IV sets the minimum content structure for the technical documentation providers must draw up under Article 11: a general system description, design and development details, information on monitoring and control, risk management system details, and validation/testing information, kept current across the system's lifecycle.
- 02 Dec 2027 Applies to Annex III high-risk systems
- 02 Aug 2028 Applies to Annex I embedded high-risk systems
- Structure the technical documentation file according to the Annex IV content list.
- Include a general description of the system, its intended purpose, and its interaction with hardware or other software.
- Include design specifications, development methodology, and information on monitoring, functioning, and control of the system.
- Include the risk management system documentation required under Article 9 and the validation/testing information showing compliance with Articles 9 to 15.
- Keep the documentation current as the system changes.
- Annex IV-structured technical documentation file
Annex IV documentation is sometimes assembled once before launch and then left static; it must be kept up to date across the system's lifecycle, and a stale file is itself a compliance gap.
What regulators published on Annex IV
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Get free accessInformational content only. Not legal advice and not a substitute for qualified counsel. Dates reflect Regulation (EU) 2026/1744 as of 04 Aug 2026.