Article 32 — Presumption of conformity of notified bodies (EU AI Act)

Article 32 of Regulation (EU) 2024/1689 — Presumption of conformity of notified bodies. Official text, practical interpretation, key obligations and compliance implications.

Official Text Summary

Article 32 of Regulation (EU) 2024/1689 establishes a presumption of conformity for notified bodies that apply harmonised standards adopted under European Union law. Specifically, where a conformity assessment body demonstrates conformity with the criteria laid down in the harmonised standards — or with relevant parts of those standards — whose references have been published in the Official Journal of the European Union, that body is presumed to satisfy the requirements set out in Article 31 to the extent that the applicable harmonised standards cover those requirements.

Article 31 establishes the substantive criteria that a conformity assessment body must meet before a Member State's notifying authority can notify it to the European Commission: independence, technical competence, impartiality, financial soundness, liability coverage, confidentiality obligations, and appropriate internal governance structures. Article 32 creates a streamlined evidentiary path by which a body can demonstrate compliance with those criteria through reference to published harmonised standards, rather than requiring case-by-case assessment of each criterion from first principles.

The presumption is rebuttable and conditional: it applies only to the extent that the harmonised standards in question actually cover the relevant Article 31 requirements. Where gaps exist — either because no standard has been published or because a standard does not address a particular requirement — conformity must be demonstrated through other evidence. The article thus functions as a conformity shortcut within a broader framework of substantive accountability, maintaining the integrity of the notified body system while reducing administrative friction for well-governed assessment bodies.

What This Means in Practice

Article 32 is primarily relevant to conformity assessment bodies seeking notification status under the EU AI Act and to the national notifying authorities that evaluate their applications.

For a conformity assessment body wishing to act as a notified body for high-risk AI systems, the practical path under Article 32 is straightforward in principle: identify the harmonised standards whose references the Commission has published in the Official Journal, demonstrate conformity with those standards — typically through accreditation by a national accreditation body operating under Regulation (EC) No 765/2008 — and benefit from the presumption when the notifying authority reviews the application under Article 28 and following.

In practice, the most relevant harmonised standard for conformity assessment bodies operating in the AI space is likely to be ISO/IEC 17065 (for product certification bodies) or ISO/IEC 17020 (for inspection bodies), alongside any AI-specific harmonised standards that the Commission develops and references under Article 40. Until AI-specific harmonised standards are published, bodies must rely on existing standards and demonstrate how they map to Article 31 criteria.

For notifying authorities — the national bodies designated under Article 28 — Article 32 simplifies the evaluation workload. Where a conformity assessment body presents valid accreditation certificates against published harmonised standards, the authority may treat the covered requirements as satisfied without conducting independent verification of each criterion. This does not eliminate oversight obligations: notifying authorities retain monitoring duties under Article 33 and must act if a notified body subsequently fails to maintain compliance.

For providers of high-risk AI systems, Article 32 matters indirectly: it underpins confidence that the notified bodies assessing their systems have been verified against rigorous, publicly known standards.

Key Obligations

• A conformity assessment body seeking to benefit from the Article 32 presumption must demonstrate actual conformity with the published harmonised standards, not merely claim it — accreditation by a national accreditation body is the standard route for substantiating this.
• The presumption applies only to the extent that harmonised standards cover the specific Article 31 requirements in question; bodies must separately evidence compliance with any requirements not addressed by available standards.
• Notifying authorities must recognise the presumption when evaluating notification applications, but retain the right and duty to rebut it if evidence indicates non-compliance with underlying Article 31 requirements.
• Notified bodies must maintain continuous conformity with the applicable harmonised standards throughout the period of notification, not only at the point of initial assessment.
• Where the Commission has not yet published references to relevant harmonised standards in the Official Journal, conformity assessment bodies must demonstrate compliance with Article 31 requirements through alternative, verifiable evidence.
• The Commission must publish references to relevant harmonised standards in the Official Journal of the European Union for the Article 32 presumption mechanism to be operationally available.

Relationship to Other Articles

Article 32 cannot be read in isolation from the surrounding Chapter 4 framework. Its direct referent is Article 31, which enumerates the substantive requirements for notified bodies; Article 32 solely addresses the evidentiary mechanism for satisfying those requirements and has no independent substantive content.

Article 28 establishes the notifying authorities responsible for assessing and notifying conformity assessment bodies, and those authorities are the primary actors who apply or decline to apply the Article 32 presumption during notification procedures governed by Articles 29 and 30.

Article 33 governs the operational obligations of notified bodies once designated, including cooperation duties with notifying authorities that are relevant when the presumption must be maintained over time. Article 40 — which establishes the harmonised standards regime for the AI Act more broadly — is the mechanism by which the Commission develops and references the standards that Article 32 relies upon.

Beyond Chapter 4, Article 43 is relevant because it specifies the conformity assessment procedures that notified bodies must conduct for high-risk AI systems; the competence and governance of those bodies, validated through Articles 31 and 32, directly determines the credibility of those assessments.

Compliance Timeline

The EU AI Act entered into force on 1 August 2024, twenty days after its publication in the Official Journal of the European Union on 12 July 2024. Article 32, situated in Title III Chapter 4, belongs to the provisions governing the infrastructure for high-risk AI system oversight and does not fall within the early application tranches.

The prohibited AI practices under Article 5 became applicable on 2 February 2025. General-purpose AI model obligations under Title VIII became applicable on 2 August 2025. The obligations most directly connected to Article 32 — the full high-risk AI system conformity assessment regime including the notified body framework — become applicable progressively from 2 August 2026 for high-risk systems listed in Annex III, with a further extension to 2 August 2027 for certain high-risk AI systems already subject to existing Union harmonisation legislation listed in Annex I.

Conformity assessment bodies that intend to act as notified bodies under the AI Act should therefore have initiated their accreditation and notification processes well before August 2026, as the notification procedure under Articles 28 through 30 involves national authority assessment, Commission notification, and a waiting period before a body may lawfully perform conformity assessments. National notifying authorities should ensure that their evaluation frameworks reflect published harmonised standards as they become available, so that the Article 32 presumption mechanism is operationally functional by the time the high-risk regime applies in full.