Article 46: Derogation From Conformity Assessment Procedure | EU AI Act

Article 46 of the AI Act provides information related to derogation from conformity assessment procedure.

A market surveillance authority can authorize a high-risk AI system to be placed on the market or into service within the territory of the Member State concerned, despite non-compliance with Article 43, if there are compelling reasons related to public security, human life and health, environmental protection, or protection of key industrial and infrastructural assets.

Such authorization will only be for a limited period while the relevant conformity assessment procedures are carried out, considering exceptional reasons that justify the derogation. These procedures must be completed without unnecessary delay.

In cases of urgency due to exceptional reasons of public security or in the case of a specific, substantial, and imminent threat to the life or physical safety of natural persons, the law enforcement authorities or civil protection authorities may put a high-risk AI system into service without appropriate authorization as described above if such authorization is requested during or after the use of such a system without undue delay. In case the request is rejected, the use of such a system must be ceased immediately with the outputs and results discarded in a similarly immediate manner.

The authorization can only be issued if the market surveillance authority concludes that the high-risk AI system properly complies with the above-outlined requirements. The market surveillance authority must duly inform the Commission and other Member States of any authorizations it issues. However, this obligation does not cover sensitive operational data related to the activities of law enforcement authorities.

If a Member State or the Commission does not object within 15 days of receiving any information related to such an authorization by the market surveillance authority of a member state, the authorization will be deemed justified.

However, if objections are raised within this timeframe by a member state or the Commission against an authorization issued by a market surveillance authority of another Member State, the Commission must consult with the relevant Member State. The concerned operators will be consulted and given the chance to present their views. After considering these inputs, the Commission must determine whether the authorization is justified, with the decision duly communicated to both the operators and the Member State.

If the Commission finds the authorization unjustified, the market surveillance authority of the concerned Member State will withdraw it.