AI Act Technical Documentation (Annex IV)
The information set a provider must maintain to demonstrate a high-risk AI system's compliance with Articles 8 to 15.
Definition
Article 11 and Annex IV require providers of high-risk AI systems to prepare and keep up to date technical documentation covering system description, design specification, monitoring and control, risk management, training and testing data (methodology, provenance, labelling, cleaning), validation and testing procedures, cybersecurity, and the post-market monitoring plan.What this means in practice
For medical devices, Annex IV elements fold into the MDR Annex II or IVDR Annex II technical documentation rather than sitting in a separate file. Data-governance evidence (Article 10) is the section most often underdeveloped in existing device technical files.- •Treating Annex IV as boilerplate. Notified bodies specifically probe training-data provenance and labelling processes.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsFor AI-enabled medical devices, AI Act requirements are assessed through the MDR/IVDR notified-body procedure, not a separate CE route.
AI systems captured by Article 6 of the EU AI Act because they are safety components of regulated products or listed in Annex III.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Primary references
3 sources- 1
Regulation (EU) 2024/1689, Article 11 and Annex IVVerifiedEUR-Lexeur-lex.europa.eu
- 2
IMDRF DocumentsVerifiedIMDRFimdrf.org
- 3
RAPS Regulatory FocusVerifiedRAPSraps.org
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