Navigating the Conformity Assessment Process Under the EU AI Act
The EU AI Act introduces a rigorous framework for regulating high-risk AI systems, with conformity assessments playing a central role in ensuring compliance. Understanding when and how to conduct these assessments is crucial for any organization developing or deploying AI within the European market. This post will provide a comprehensive overview of the conformity assessment process under the EU AI Act.
What is a Conformity Assessment?
A conformity assessment is a systematic process to demonstrate that a high-risk AI system meets the requirements set out in the EU AI Act. It involves evaluating the system’s design, development, and performance against specific criteria related to accuracy, robustness, transparency, and data governance. The aim is to ensure that the system operates as intended and does not pose unacceptable risks to fundamental rights, health, and safety.
When is a Conformity Assessment Required?
Conformity assessments are mandatory for all high-risk AI systems before they can be placed on the European market or put into service. As outlined in previous posts, high-risk AI systems are those that:
Have a direct impact on natural persons.
Create a risk to the health/safety or fundamental rights of natural persons.
This includes AI systems used in areas such as:
Credit scoring and assessment
Risk assessment in life and health insurance
Critical infrastructure management
Education and vocational training
Employment, worker management and access to self-employment
Essential private and public services
Law enforcement
Migration, asylum and border control
Administration of justice and democratic processes.
If your AI system falls into any of these categories, a conformity assessment is non-negotiable.
How to Conduct a Conformity Assessment: A Step-by-Step Guide
The EU AI Act outlines a detailed conformity assessment procedure that typically involves the following steps:
- Identify Applicable Requirements: Determine which specific requirements of the EU AI Act apply to your high-risk AI system based on its intended use and risk profile.
- Technical Documentation Compilation: Create comprehensive technical documentation that demonstrates how your AI system meets the identified requirements. This documentation should include details on the system’s design, development process, data sources, algorithms, performance metrics, and risk mitigation measures. Refer to the EU AI Act guidelines to ensure comprehensive documentation.
- Internal Assessment (or Notified Body Involvement): You can choose to perform the conformity assessment internally (if your organization possesses the necessary expertise) or engage a notified body. Notified bodies are independent organizations designated by EU member states to assess the conformity of specific product categories.
- Assessment of Technical Documentation: Whether performed internally or by a notified body, the technical documentation will be thoroughly assessed to verify that the AI system meets the required standards.
- Testing and Validation: Conduct thorough testing and validation of the AI system to ensure it performs as intended and meets the specified performance criteria. This may involve using representative datasets and simulating real-world scenarios.
- Risk Assessment and Mitigation: Identify and assess potential risks associated with the AI system and implement appropriate mitigation measures to address those risks.
- Corrective Actions (if needed): If the assessment reveals any non-conformities, take corrective actions to address the issues and bring the AI system into compliance.
- Declaration of Conformity: Once the conformity assessment is completed successfully, draw up an EU declaration of conformity. This document states that the AI system meets all applicable requirements of the EU AI Act and is ready to be placed on the market.
- CE Marking: Affix the CE marking to the AI system to indicate that it conforms to the EU AI Act.
- Ongoing Monitoring and Updates: Even after the conformity assessment is completed, it’s important to continuously monitor the AI system’s performance and update the technical documentation as needed to reflect any changes or improvements.
Prioritizing Conformity for Responsible AI
Conformity assessments are a cornerstone of the EU AI Act, designed to ensure that high-risk AI systems are developed and used responsibly. By understanding the requirements and following the outlined process, organizations can demonstrate their commitment to ethical and trustworthy AI and unlock the benefits of this transformative technology while minimizing potential risks.