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Conformity assessments under the EU AI Act: Ensuring compliance, safety, and trust in artificial intelligence

The advent of artificial intelligence (AI) has ushered in an era of unprecedented technological advancements, transforming various sectors by enhancing efficiency, accuracy, and decision-making capabilities. However, the proliferation of AI technologies also brings forth significant challenges, particularly concerning safety, fairness, transparency, and accountability. In response to these challenges, the European Union (EU) has proposed and the European Parliament has formally adapted the EU AI Act, a comprehensive regulatory framework aimed at fostering innovation while ensuring the safe and ethical deployment of AI systems. A central element of this framework is the requirement for conformity assessments, particularly for high-risk AI systems. This article explores the intricacies of conformity assessments as mandated by the EU AI Act, detailing their purpose, processes, and implications for AI developers and users.

Purpose of conformity assessments

Conformity assessments serve as a critical mechanism within the EU AI Act, designed to verify that AI systems adhere to the established legal and regulatory standards. The primary objectives of these assessments are multifaceted: they aim to ensure compliance with the EU AI Act, enhance the safety and reliability of AI systems, promote public trust, and ensure accountability among developers and deployers of AI technologies. By subjecting AI systems to rigorous scrutiny, conformity assessments help mitigate potential risks associated with AI, thereby safeguarding users’ rights and interests.

Regulatory context and requirements

The EU AI Act categorises AI systems into different risk levels, with high-risk AI systems being subject to the most stringent requirements. These systems, which include applications in critical infrastructure, healthcare, law enforcement, and employment, are assessed against a comprehensive set of criteria to ensure their safe and ethical operation.

Risk management system: One of the foundational requirements for high-risk AI systems is the implementation of a robust risk management system. This system must encompass the entire lifecycle of the AI product, from initial design and development to deployment and post-market monitoring. It involves identifying, analysing, and mitigating potential risks that the AI system might pose. Continuous monitoring and periodic updates to the risk management measures are also mandated to adapt to emerging threats and vulnerabilities.

Technical documentation: Comprehensive technical documentation is a cornerstone of the conformity assessment process. Developers are required to maintain detailed records that describe the design, specifications, algorithms, data sources, testing methods, and performance metrics of the AI system. This documentation must be sufficiently detailed to allow external auditors and regulators to understand and verify the AI system’s compliance with the EU AI Act.

Data governance: High-risk AI systems must adhere to strict data governance standards to ensure the quality, integrity, and relevance of the data used in their training, validation, and testing phases. This includes measures to prevent and mitigate biases in the data, which could lead to discriminatory outcomes. Ensuring data accuracy and completeness is essential for the reliable performance of AI systems.

Transparency and explainability: Transparency is a key principle underpinning the EU AI Act. AI systems must be designed to provide clear and understandable information about their capabilities, limitations, and decision-making processes. Users should be informed when they are interacting with an AI system, and mechanisms should be in place to explain the rationale behind the AI’s decisions. This fosters trust and enables users to make informed choices about the AI technologies they use.

Human oversight: The EU AI Act emphasises the importance of human oversight in the operation of AI systems. High-risk AI systems must be designed to allow human operators to intervene and override decisions when necessary. This ensures that critical decisions, particularly those affecting health, safety, and fundamental rights, are subject to human judgement and control.

Cyber security and resilience: Given the increasing threats to cyber security, the EU AI Act mandates that AI systems incorporate robust cyber security measures. These measures are designed to protect the AI system from attacks, data breaches, and other security vulnerabilities. Ensuring the resilience of AI systems is crucial to maintaining their functionality and reliability in adverse conditions.

Process of conformity assessments

The process of conducting conformity assessments under the EU AI Act involves several stages, each designed to ensure that AI systems meet the necessary standards and requirements.

Preparation: The preparation phase involves gathering and organising all necessary documentation and evidence to demonstrate the AI system’s compliance with the EU AI Act. This includes compiling technical documentation, risk assessments, testing results, and internal audit reports. Developers must ensure that all relevant information is readily available for review by auditors or notified bodies.

Assessment: The assessment phase involves a thorough review and evaluation of the AI system against the criteria specified in the EU AI Act. For some high-risk AI systems, this may be conducted internally by the organisation. However, for higher-risk systems, an independent external assessment by a notified body is required. These notified bodies are accredited organisations authorised to evaluate and certify AI systems’ compliance. The assessment process may include audits, inspections, and testing to verify that the AI system meets the required standards.

Certification: Upon successful completion of the assessment, the AI system may receive a certificate of conformity. This certification indicates that the system complies with the EU AI Act and meets all necessary requirements. Certification is essential for high-risk AI systems to be marketed and used within the EU. It provides assurance to users and regulators that the AI system has undergone rigorous evaluation and adheres to safety, fairness, and transparency standards.

Continuous compliance: Compliance with the EU AI Act is not a one-time requirement but an ongoing obligation. Developers must implement continuous monitoring and periodic reviews to ensure that the AI system remains compliant throughout its lifecycle. This includes updating risk management practices, maintaining technical documentation, and reporting any incidents, malfunctions, or significant changes to the AI system to relevant authorities.

Implications for AI developers and users

The conformity assessment requirements imposed by the EU AI Act have significant implications for AI developers and users. For developers, these requirements necessitate a proactive approach to compliance, involving substantial investment in risk management, data governance, transparency, and cyber security. Developers must establish robust internal processes to document, monitor, and review their AI systems continuously. The need for external assessments by notified bodies also introduces additional costs and administrative burdens. However, these measures are essential to ensure the safe and ethical deployment of AI technologies and to build public trust in AI systems.

For users, the conformity assessment framework provides assurance that high-risk AI systems have been rigorously evaluated and meet stringent standards. This fosters trust in AI technologies and enables users to make informed decisions about their adoption and use. The transparency and explainability requirements also empower users by providing them with clear information about the AI systems they interact with and the rationale behind their decisions.

Challenges and future directions

While the EU AI Act’s conformity assessment requirements represent a significant step towards ensuring the safe and ethical deployment of AI systems, they also pose several challenges. One of the primary challenges is the potential for increased regulatory burden and compliance costs for AI developers. Small and medium-sized enterprises (SMEs) may find it particularly challenging to meet the stringent requirements, which could hinder innovation and competitiveness.

Another challenge is the need for harmonisation and standardisation of conformity assessment processes across different member states. Ensuring consistency and uniformity in the application of the EU AI Act’s requirements is crucial to avoid fragmentation and ensure a level playing field for AI developers.

To address these challenges, the EU and relevant stakeholders must work collaboratively to develop clear guidelines, best practices, and support mechanisms for AI developers. This includes providing technical assistance, training, and resources to help developers navigate the conformity assessment process. Additionally, fostering international cooperation and alignment with global AI standards can enhance the effectiveness and efficiency of conformity assessments.


The EU AI Act’s conformity assessment requirements represent a comprehensive and rigorous approach to ensuring the safe, ethical, and transparent deployment of high-risk AI systems. By establishing clear standards and processes for risk management, data governance, transparency, and cyber security, the EU AI Act aims to mitigate potential risks and promote public trust in AI technologies. While the implementation of these requirements poses challenges for AI developers, particularly in terms of compliance costs and administrative burdens, they are essential for safeguarding users’ rights and interests.

As AI technologies continue to evolve and proliferate, the importance of robust conformity assessments cannot be overstated. By adhering to the EU AI Act’s requirements, developers can ensure that their AI systems operate safely, fairly, and transparently, thereby contributing to the responsible and sustainable development of AI. The ongoing collaboration between regulators, developers, and other stakeholders will be crucial in addressing the challenges and realising the full potential of AI technologies in a manner that aligns with societal values and ethical principles.

For more information, please contact:

Robert Szuchy, managing partner

BSLAW Brussels
Avenue Michel-Ange 10., 1000 Bruxelles | T: +32 240 18712 |

BSLAW Budapest
Szuchy Ügyvédi Iroda, 1054 Budapest, Aulich utca 8 | T: +36 1 700 1035 |