Article 46: Derogation from Conformity Assessment Procedure
1.
By way of derogation from Article 43 and upon a duly justified request, any market surveillance authoritymarket surveillance authorityAny national authority responsible for carrying out market surveillance on the territory of the Member State concernedRegulation (EU) 2019/1020 Art. 3(4) may authorise the placing on the marketplacing on the marketmeans the first making available of an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) or a general-purpose AI model on the Union marketArticle 3(9) or the putting into serviceputting into servicemeans the supply of an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) for first use directly to the deployerdeployermeans a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activityArticle 3(4) or for own use in the Union for its intended purposeintended purposemeans the use for which an AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) is intended by the providerprovidermeans a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of chargeArticle 3(3), including the specific context and conditions of use, as specified in the information supplied by the providerprovidermeans a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of chargeArticle 3(3) in the instructions for use, promotional or sales materials and statements, as well as in the technical documentationArticle 3(12)Article 3(11) 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 assessmentconformity assessmentmeans the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) have been fulfilledArticle 3(20) 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 systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) 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 systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) 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 authoritymarket surveillance authorityAny national authority responsible for carrying out market surveillance on the territory of the Member State concernedRegulation (EU) 2019/1020 Art. 3(4) concludes that the high-risk AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) complies with the requirements of Section 2. The market surveillance authoritymarket surveillance authorityAny national authority responsible for carrying out market surveillance on the territory of the Member State concernedRegulation (EU) 2019/1020 Art. 3(4) 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 datasensitive operational datameans operational data related to activities of prevention, detection, investigation or prosecution of criminal offences, the disclosure of which could jeopardise the integrity of criminal proceedingsArticle 3(38) 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 authoritymarket surveillance authorityAny national authority responsible for carrying out market surveillance on the territory of the Member State concernedRegulation (EU) 2019/1020 Art. 3(4) 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 authoritymarket surveillance authorityAny national authority responsible for carrying out market surveillance on the territory of the Member State concernedRegulation (EU) 2019/1020 Art. 3(4) 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 authoritymarket surveillance authorityAny national authority responsible for carrying out market surveillance on the territory of the Member State concernedRegulation (EU) 2019/1020 Art. 3(4) 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 assessmentconformity assessmentmeans the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI systemAI systemmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environmentsArticle 3(1) have been fulfilledArticle 3(20) established in that Union harmonisation legislation shall apply.