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EU AI Act - Conformity Assessments 101

How the EU AI Act Conformity Assessments Will Affect AI Governance


The European Union is set to become the first region in the world to regulate artificial intelligence (AI) with the passage of the Artificial Intelligence Act (AIA). The AIA is a comprehensive piece of legislation that sets out a number of requirements for AI systems, including those that are considered to be high-risk.

One of the key requirements of the AIA is that high-risk AI systems must undergo a conformity assessment before they can be placed on the market or used in the EU. This conformity assessment is designed to ensure that high-risk AI systems meet the requirements of the AIA and are not likely to pose a risk to people's safety, fundamental rights, or the environment.

The conformity assessment process can be complex and time-consuming, but it is essential for companies that develop or use high-risk AI systems in the EU. By understanding the conformity assessment requirements and how they will affect AI governance, companies can ensure that they are compliant with the AIA and are taking steps to develop and use AI responsibly.

What is a Conformity Assessment?

A conformity assessment is a process that is used to verify whether a product, service, or system meets the requirements of a particular standard or regulation. In the context of the AIA, a conformity assessment is used to verify whether a high-risk AI system meets the requirements set out in Title III, Chapter 2 of the legislation.

The conformity assessment process can be conducted either internally by the provider of the AI system or by a notified third-party entity. If the provider chooses to conduct the conformity assessment internally, they must follow the procedure set out in Annex VI of the AIA. This procedure includes a number of steps, such as:

  • Identifying the risks associated with the AI system

  • Assessing the measures that have been taken to mitigate those risks

  • Documenting the conformity assessment process

  • Drawing up a declaration of conformity

If the provider chooses to have the conformity assessment conducted by a notified third-party entity, they must first ensure that the entity is authorized to conduct conformity assessments in the EU. The provider must then provide the entity with all of the information that is necessary to conduct the assessment, such as the technical documentation for the AI system and the results of any risk assessments that have been conducted.

How Do Conformity Assessments Affect AI Governance?

The conformity assessment requirements of the AIA have a number of implications for AI governance. First, they require companies to take a more proactive approach to risk management. By identifying and assessing the risks associated with their AI systems, companies can develop and implement measures to mitigate those risks. This helps to ensure that AI systems are used safely and responsibly.

Second, the conformity assessment requirements require companies to document their AI governance processes. This documentation can be used to demonstrate compliance with the AIA and to help companies identify and address any potential problems with their AI systems.

Third, the conformity assessment requirements can help to build trust in AI. By demonstrating that their AI systems have been properly assessed and are compliant with the AIA, companies can help to reassure customers and the public that their AI systems are safe and reliable.


How Can AI Governance Software Help?

AI governance software can help companies to comply with the conformity assessment requirements of the AIA in a number of ways. First, such software can help companies to identify and assess the risks associated with their AI systems. Second, it can help companies to document their AI governance processes. Third, it can help companies to track and manage the conformity assessment process.

One AI governance software product that can help companies with conformity assessments is AI Guardian. AI Guardian is a cloud-based platform that provides a comprehensive set of tools for managing AI risk and compliance. The platform includes features for risk assessment, documentation, and conformity assessment.

The conformity assessment requirements of the AIA are a significant step forward in the regulation of AI. By requiring companies to assess the risks associated with their AI systems and to document their AI governance processes, the AIA helps to ensure that AI is used safely and responsibly. AI governance software can help companies to comply with these requirements and to build trust in AI.


If you are a company that develops or uses high-risk AI systems in the EU, it is important to understand the conformity assessment requirements of the AIA and how they will affect your AI governance practices. By taking a proactive approach to risk management and documenting your AI governance processes, you can help to ensure that your AI systems are compliant with the AIA and are used safely and responsibly.



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