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Chapter III, Section 5 — Standards, conformity assessment, certificates, registrationArticle 46

Article 46: Derogation from Conformity Assessment Procedure

Applies from 2 Aug 20263 min readEUR-Lex verified Apr 2026

Article 46 allows market surveillance authorities to grant a derogation from the normal conformity assessment procedure for a high-risk AI system on exceptional grounds of public security, protection of life and health, environmental protection, or protection of key industrial and infrastructure assets. The derogation is temporary and limited — the system must still meet the requirements within a specified period, and the authority must inform the Commission and other Member States. This is the AI Act's urgency valve for situations where waiting for full conformity assessment would cause disproportionate harm.

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Who does this apply to?

  • -Market surveillance authorities granting emergency derogations
  • -Providers and deployers of high-risk AI systems in exceptional public interest situations
  • -The Commission and other Member States notified of derogations

Scenarios

During a major public health emergency, a Member State urgently needs to deploy a high-risk AI diagnostic triage system that has not completed its Annex VII assessment.

The market surveillance authority may grant a temporary Article 46 derogation, allowing deployment while the conformity assessment is completed in parallel.
Ref. Art. 46

A provider tries to use Article 46 to bypass routine conformity assessment for a commercial product launch.

Not permitted — Article 46 requires exceptional grounds of public interest, not commercial convenience. The authority would reject the request.
Ref. Art. 46

When derogation is available

Article 46 derogation requires exceptional grounds in one of these categories:

1. Public security — imminent threat requiring rapid AI deployment 2. Protection of life and health — health emergencies, disaster response 3. Environmental protection — urgent environmental remediation 4. Key industrial and infrastructure assets — critical infrastructure protection

The derogation is temporary — the system must be brought into full compliance within the timeframe specified by the authority. The Commission and other Member States must be notified.

How Article 46 connects to the rest of the Act

  • Article 43 — The conformity assessment procedure from which derogation is granted.
  • Article 74 — Market surveillance authorities who grant derogations.
  • Annex VI / Annex VII — The assessment procedures that would normally apply.

Compliance checklist

  • Assess whether exceptional grounds genuinely exist (public security, life/health, environment, infrastructure).
  • Apply to the market surveillance authority with documented justification.
  • If granted: comply with all conditions and the specified timeframe.
  • Complete full conformity assessment in parallel.
  • Monitor Commission and other Member State responses to the derogation notification.
Read the official text on EUR-Lex

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Frequently asked questions

How long can a derogation last?

Article 46 does not specify a fixed maximum — it depends on the authority's decision and the time needed to complete the conformity assessment. Verify the exact wording on EUR-Lex.

Does the system still need CE marking during the derogation?

The system cannot bear CE marking until conformity assessment is completed. The derogation permits deployment without CE marking during the temporary period.

When can a market surveillance authority grant a derogation under Article 46?

A derogation may be granted on exceptional grounds of public security, protection of life and health, or protection of the environment. The authorisation is limited to the territory of the granting Member State. Article 46(2) requires the authority to inform the Commission and other Member States, and the Commission may extend or withdraw the authorisation.