Article 46 — Derogation from conformity assessment procedure (EU AI Act)

Article 46 of Regulation (EU) 2024/1689 — Derogation from conformity assessment procedure. Official text, practical interpretation, key obligations and compliance implications.

Official Text Summary

Article 46 of Regulation (EU) 2024/1689 establishes a limited derogation mechanism allowing national competent authorities to authorise the placing on the market or putting into service of high-risk AI systems that have not undergone the standard conformity assessment procedure prescribed by Article 43. This derogation may be invoked when exceptional circumstances exist and where it is in the interest of public security, the protection of life and health of persons, the protection of industrial and commercial property, or other overriding reasons of public interest.

When a Member State grants such an authorisation, it must notify the Commission and the other Member States without delay. The authorisation specifies the AI system concerned, the purpose and duration of the authorisation, and the conditions attached to it. The Commission may, where justified, take measures to ensure that the authorisation does not adversely affect the functioning of the internal market or the level of protection required by this Regulation.

The article draws a clear distinction between the temporary and circumstance-bound nature of the derogation and the permanent compliance obligations that apply under standard conditions. Providers benefiting from a derogation are still expected to work toward full conformity and must not treat the authorisation as a permanent exemption. The mechanism mirrors analogous provisions found in EU product safety and medical device legislation, ensuring coherence with the broader EU regulatory architecture for conformity assessment.

What This Means in Practice

In practical terms, Article 46 is an emergency valve rather than a routine compliance pathway. The vast majority of providers of high-risk AI systems will never interact with this provision directly. It is relevant primarily in two scenarios: first, where a government authority or a provider working under a government mandate needs to deploy a high-risk AI system rapidly to address an urgent public safety or national security situation; second, where a Member State wishes to facilitate market access for a system of strategic importance while a full conformity assessment is pending.

Concretely, a national authority might invoke Article 46 to authorise the emergency deployment of an AI-assisted triage system during a public health crisis, or an AI tool used by law enforcement in response to an acute threat, where waiting for the full Article 43 conformity assessment procedure would create unacceptable delays.

For providers, the practical implication is that even under a derogation, obligations do not disappear — they are deferred. Providers must maintain documentation, continue developing technical files, and prepare to submit to full conformity assessment once the derogation period expires. They should treat the period under derogation as a transitional phase, not a compliance-free zone.

Member State authorities must ensure that any authorisation is narrowly scoped, time-limited, and communicated to the Commission. Legal teams advising clients in defence, security, or critical infrastructure sectors should be aware of this mechanism as a contingency option, while making clear that reliance on it carries procedural and reputational risks.

Key Obligations

• Member State notification: Any national authority granting a derogation must immediately notify the European Commission and all other Member States, providing full details of the authorisation including scope, duration, and conditions.
• Justification requirement: The authorising authority must demonstrate that exceptional circumstances exist and that the derogation is proportionate to the objective pursued; vague or generic justifications are insufficient.
• Time limitation: Derogations must be strictly time-limited; the authorisation must specify an end date or a defined trigger condition after which full conformity assessment obligations resume.
• Conditions attachment: The authorisation must set out specific conditions the provider must comply with during the derogation period, which may include enhanced monitoring, incident reporting, or use restrictions.
• Commission oversight: The Commission retains the power to assess whether a granted derogation is compatible with the integrity of the internal market and may require the Member State to withdraw or amend the authorisation.
• Continued provider obligations: Providers operating under a derogation remain responsible for maintaining technical documentation and must complete the standard conformity assessment procedure before the derogation expires.

Relationship to Other Articles

Article 46 must be read in close conjunction with Article 43 (Conformity Assessment), which establishes the standard procedure from which the derogation departs. It also connects to Article 44 (Certificates of Conformity) and Article 45 (Information Obligations of Notified Bodies), since a derogation suspends rather than replaces these mechanisms.

Article 46 is further linked to Article 74 and Article 75 on market surveillance and control of AI systems entering the Union market, as authorities granting derogations must operate within the broader oversight framework. The notification obligations under Article 46 feed into the EU database established under Article 71, ensuring that derogated systems are traceable at EU level.

Providers should also cross-reference Article 9 (Risk Management System) and Article 17 (Quality Management System), since the expectations embedded in those provisions continue to apply even during a derogation period, informing what "conditions" a national authority should impose.

Compliance Timeline

Article 46 became part of EU law upon the entry into force of Regulation (EU) 2024/1689 on 1 August 2024. However, its practical activation is tied to the phased application of obligations for high-risk AI systems.

The conformity assessment obligations under Article 43, from which Article 46 provides a derogation, apply to high-risk AI systems listed in Annex III from 2 August 2026, and to certain high-risk systems in Annex I sectors from 2 August 2027. This means Article 46 becomes operationally relevant as a derogation mechanism from those dates onward, since prior to that, the conformity assessment obligations it derogate from are not yet mandatory.

Organisations in sectors likely to face emergency deployment scenarios — critical infrastructure, law enforcement, border management, health — should include Article 46 in their regulatory preparedness planning ahead of the August 2026 application date, ensuring they understand both how to request a derogation and what obligations persist during any authorised derogation period.