# Article 46 - Derogation from conformity assessment procedure

1.
By way of derogation from Article 43 and upon a duly justified request, any market surveillance authority may 
authorise the placing on the market or the putting into service of specific high-risk AI systems within the territory of the 
Member State concerned, for exceptional reasons of public security or the protection of life and health of persons, 
environmental protection or the protection of key industrial and infrastructural assets. That authorisation shall be for 
a limited period while the necessary conformity assessment procedures are being carried out, taking into account the 
exceptional reasons justifying the derogation. The completion of those procedures shall be undertaken without undue delay.
2.
In a duly justified situation of urgency for exceptional reasons of public security or in the case of specific, substantial 
and imminent threat to the life or physical safety of natural persons, law-enforcement authorities or civil protection 
authorities may put a specific high-risk AI system into service without the authorisation referred to in paragraph 1, 
provided that such authorisation is requested during or after the use without undue delay. If the authorisation referred to in 
paragraph 1 is refused, the use of the high-risk AI system shall be stopped with immediate effect and all the results and 
outputs of such use shall be immediately discarded.
3.
The authorisation referred to in paragraph 1 shall be issued only if the market surveillance authority concludes that 
the high-risk AI system complies with the requirements of Section 2. The market surveillance authority shall inform the 
Commission and the other Member States of any authorisation issued pursuant to paragraphs 1 and 2. This obligation shall 
not cover sensitive operational data in relation to the activities of law-enforcement authorities.
4.
Where, within 15 calendar days of receipt of the information referred to in paragraph 3, no objection has been raised 
by either a Member State or the Commission in respect of an authorisation issued by a market surveillance authority of 
a Member State in accordance with paragraph 1, that authorisation shall be deemed justified.
5.
Where, within 15 calendar days of receipt of the notification referred to in paragraph 3, objections are raised by 
a Member State against an authorisation issued by a market surveillance authority of another Member State, or where the 
Commission considers the authorisation to be contrary to Union law, or the conclusion of the Member States regarding the 
compliance of the system as referred to in paragraph 3 to be unfounded, the Commission shall, without delay, enter into 
consultations with the relevant Member State. The operators concerned shall be consulted and have the possibility to 
present their views. Having regard thereto, the Commission shall decide whether the authorisation is justified. The 
Commission shall address its decision to the Member State concerned and to the relevant operators.
6.
Where the Commission considers the authorisation unjustified, it shall be withdrawn by the market surveillance 
authority of the Member State concerned.
7.
For high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of 
Annex I, only the derogations from the conformity assessment established in that Union harmonisation legislation shall 
apply.

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Source: Regulation (EU) 2024/1689 (Artificial Intelligence Act) as amended by Regulation (EU) 2026/1744, consolidated text of 27 July 2026 (Official Journal of the EU). This page is AI-generated legal information, not legal advice. Verify against the Official Journal.
Canonical: https://euaiactlaw.com/article/46