Antonio Tejeda Encinas , President of the Euro-American Committee on Digital Law
The recent approval of the Regulation of the European Parliament and of the Council laying down harmonized rules on artificial intelligence (AI) in the European Union marks a new milestone in the legal regulation of these systems. This Artificial Intelligence Act (AI Act) is intended to improve the functioning of the internal market through a uniform legal framework that promotes the development, marketing and use of AI systems consistent with Union values; promotes human-centric, trustworthy and safe AI; and ensures the protection of health, safety and fundamental rights.
The AI Act establishes a harmonized legal framework for the development, marketing and use of AI products and services in the European Union. Its specific objectives include:
1. Ensuring that AI systems placed on the EU market are safe and comply with existing legislation.
2. Providing legal certainty to facilitate investment and innovation in AI.
3. Improving governance and the effective enforcement of EU legislation on fundamental rights and safety requirements applicable to AI systems.
4. Facilitating the development of a single market for lawful, safe and trustworthy AI applications while preventing market fragmentation.
A fundamental obligation for providers of high-risk AI systems is the preparation of comprehensive technical documentation before those systems are placed on the market. This documentation must demonstrate compliance with the requirements of the AI Act and facilitate assessment by regulatory bodies, providing legal certainty to deployers.
Article 11 of the AI Act establishes the need to prepare and continuously update this documentation throughout the AI system’s life cycle. Its purpose is to provide clear and complete information to the competent national authorities and deployers.
The technical documentation must include:
a) A general description of the AI system, its intended purpose, interactions with hardware and software, user interface and instructions for use.
b) Details of the system-development process, including methodologies, design specifications, system architecture, third-party components, datasets used, human-oversight measures, and validation and testing procedures.
c) Information on the system’s monitoring, operation and control, including capabilities and limitations, unintended outcomes, human-oversight measures and input-data specifications.
d) Performance parameters of the AI system.
e) A description of the risk-management system.
f) A record of changes made to the system throughout its life cycle.
g) A list of the harmonized standards applied.
h) A copy of the EU declaration of conformity.
i) A description of the post-market evaluation system, including the monitoring plan.
This documentation must be retained for ten years after the high-risk AI system is placed on the market or put into service. It must also be consistent with the manufacturer’s AI-governance policy and the documentation relating to CE marking.
The technical documentation must be prepared comprehensively to demonstrate compliance with the AI Act’s rules and enable effective operational oversight and post-market control. For high-risk AI systems related to products covered by EU harmonization legislation, a single set of technical documentation may be prepared combining the information required by the AI Act and the corresponding legislation, thereby minimizing additional burdens on providers.
