Art.46
EU AI Act Guide › Chapter III — High-Risk AI Systems › Article 46

Article 46 — Derogation from Conformity Assessment Procedure

Governance SME Relevant ~2 min read · 485 words

Article 46 creates a narrow but important exception to the normal conformity assessment requirement. In justified exceptional circumstances — particularly where public safety, national security, or urgent operational needs are involved — market surveillance authorities can authorise the use of a high-risk AI system before its conformity assessment is complete. This is a genuine emergency provision, not a general shortcut.

✓ Low compliance impact for SMEs

WHAT THE ARTICLE IS ABOUT

Emergency authorisation for high-risk AI in exceptional circumstances

Article 46 establishes a derogation mechanism — a limited exception to the requirement that high-risk AI systems must complete conformity assessment before being placed on the market. It allows market surveillance authorities to grant provisional authorisation for use in urgent circumstances, with strict conditions and limited timeframes.

WHAT IT SAYS

Provisional authorisation, 15-day objection window, strict conditions

  • Where it is in the interest of public security, the protection of life and health, or the protection of the environment, and completing the conformity assessment procedure would result in an unreasonable delay, a market surveillance authority may authorise provisional use of a specific high-risk AI system in its territory
  • The authorisation is provisional and limited — it must specify the period of validity and may impose conditions on the use of the system
  • The market surveillance authority must inform the Commission and other member states of the authorisation issued, unless it relates to sensitive law enforcement operational data
  • Other member states and the Commission have 15 calendar days to raise objections — if no objection is raised, the authorisation is deemed justified
  • For law enforcement and civil protection authorities in exceptional urgency situations: the system may be put into service immediately without prior authorisation, provided a request for authorisation is submitted without undue delay
  • Authorisations may be extended where necessary, subject to Commission agreement

WHO IS AFFECTED

Public authorities and emergency services in exceptional circumstances

  • Law enforcement authorities responding to urgent threats requiring AI capabilities before assessment completion
  • Civil protection bodies responding to natural disasters, public health emergencies, or security threats
  • Market surveillance authorities empowered to grant provisional authorisations
  • The Commission and other member states in the oversight and objection process
  • Providers whose systems may be authorised for provisional use — they remain responsible for completing full conformity assessment

WHAT IT MEANS FOR SMES

Relevant if you supply to public authorities in emergency contexts

  • For most commercial SMEs, this article will never be directly relevant — it is primarily an emergency tool for public authorities and their suppliers
  • If you supply AI systems to public authorities in sectors like law enforcement, healthcare, or civil protection, this article creates a pathway for provisional deployment during emergencies — understand it as a potential fast-track for specific contracts
  • Provisional authorisation does not exempt you from completing the full conformity assessment — it only delays the requirement; plan for completing assessment promptly
  • The 15-day objection window means provisional authorisations can be challenged — do not assume a granted authorisation is permanent
  • If your system is used under a derogation, document everything — the exceptional circumstances, the authority’s authorisation, and your plan for completing the full assessment

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