Conformity assessment procedures under the AI Act
DOI:
https://doi.org/10.71265/we1c0452Keywords:
Artificial Intelligence, Artificial Intelligence Act (AI Act), Conformity Assessment, Accreditation, Trustworthy AI, Standards, CertificationAbstract
This article critically analyses conformity assessment procedures for high-risk AI systems under the AI Act. It maps the applicable procedures to different types of AI systems, offering structured guidance for implementation. The article then evaluates the AI Act’s reliance on procedures laid down in other Union harmonisation legislation. It demonstrates how this reliance leads to a risk classification that fails to adequately consider AI-specific risks, and questions the suitability of various procedures for assessing AI systems. Finally, it explores how the assignment of these conformity assessment procedures impacts the requirements that conformity assessment bodies must adhere to. By offering this analysis of the regulatory landscape, this article contributes to a better understanding of the AI Act’s systemic challenges and identifies regulatory blind spots.
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References
Gabriele Mazzini and Salvatore Scalzo, ‘The Proposal for the Artificial Intelligence Act: Considerations around Some Key Concepts’ (2022) SSRN https://www.ssrn.com/abstract=4098809 accessed 11 February 2026;
Claudio Novelli and others, ‘A Robust Governance for the AI Act: AI Office, AI Board, Scientific Panel, and National Authorities’ [2024] European Journal of Risk Regulation 1;
Nathalie A Smuha and Karen Yeung, ‘The European Union’s AI Act: Beyond Motherhood and Apple Pie?’ (2024) SSRN https://www.ssrn.com/abstract=4874852 accessed 11 February 2026;
Michael Veale and Frederik Zuiderveen Borgesius, ‘Demystifying the Draft EU Artificial Intelligence Act — Analysing the Good, the Bad, and the Unclear Elements of the Proposed Approach’ (2021) 22 Computer Law Review International 97.
Luciano Floridi and others, ‘capAI - A Procedure for Conducting Conformity Assessment of AI Systems in Line with the EU Artificial Intelligence Act’ (2022) SSRN https://www.ssrn.com/abstract=4064091 accessed 11 February 2026.
Eva Thelisson and Himanshu Verma, ‘Conformity Assessment under the EU AI Act General Approach’ (2024) 4 AI and Ethics 113.
Christian Johner, ‘Was der AI Act für Medizinprodukte- und IVD-Hersteller bedeutet’ (Johner Institut, 2024) https://www.johner-institut.de/blog/iec-62304-medizinische-software/ai-act-eu-ki-verordnung/ accessed 11 February 2026.
Von Zahn M and others, ‘Navigating AI Conformity: A Design Framework to Assess Fairness, Explainability, and Performance’ (2025) 35
Hannah Ruschemeier and Jascha Bareis, ‘Searching for Harmonised Rules: Understanding the Paradigms, Provisions and Pressing Issues in the Final EU AI Act’ (2024) SSRN https://www.ssrn.com/abstract=4876206 accessed 11 February 2026
Henk J de Vries and others, ‘Conformity Assessment’ in Wilfried Hesser (ed), Standardization in Companies and Markets (Helmut-Schmidt-Universität, Universität der Bundeswehr Hamburg 2010).
Kevin B Johnson and others, ‘Precision Medicine, AI, and the Future of Personalized Health Care’ (2021) 14 Clinical and Translational Science 86.
Sebastian Steinbach and Johannes Kröhnert, ‘Stellungnahme: Vorschlag Der EU-Kommission Für Ein Gesetz Über Künstliche Intelligenz (COM(2021) 206)’ (TÜV Verband 2021) 4 https://www.tuev-verband.de/index.php?eID=dumpFile&t=f&f=2110&token=de53226ed9443a29b40681835523f430834b10e6.
Anton Khritankov, ‘Hidden Feedback Loops in Machine Learning Systems: A Simulation Model and Preliminary Results’ in Dietmar Winkler and others (eds), Software Quality: Future Perspectives on Software Engineering Quality, vol 404 (Springer International Publishing 2021); Katharina A Zweig, Georg Wenzelburger and Tobias D Krafft, ‘On Chances and Risks of Security Related Algorithmic Decision Making Systems’ (2018) 3 European Journal for Security Research 181.
Amina Adadi and Mohammed Berrada, ‘Peeking Inside the Black-Box: A Survey on Explainable Artificial Intelligence (XAI)’ (2018) 6 IEEE Access 52138
Vikas Hassija and others, ‘Interpreting Black-Box Models: A Review on Explainable Artificial Intelligence’ (2024) 16 Cognitive Computation 45.
Gernot Rieder, Judith Simon and Pak-Hang Wong, ‘Mapping the Stony Road toward Trustworthy AI: Expectations, Problems, Conundrums’ in Marcello Pelillo and Teresa Scantamburlo (eds), Machines We Trust (The MIT Press 2021).
Teresa Anjinho, ‘How the European Commission Ensures Transparency, Inclusiveness and Accountability in the Adoption of Harmonised Standards Related to Artificial Intelligence’ (Case 1974/2025/MIK, 2025) https://www.ombudsman.europa.eu/en/opening-summary/en/212090
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