Chapter 3

1. Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b)…

1. The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend Annex III by adding or modifying use-cases of high-risk…

1. High-risk AI systems shall comply with the requirements laid down in this Section, taking into account their intended purpose as well as the…

1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems.

1. High-risk AI systems which make use of techniques involving the training of AI models with data shall be developed on the basis of training…

1. The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be…

1. High-risk AI systems shall technically allow for the automatic recording of events (logs) over the lifetime of the system.

1. High-risk AI systems shall be designed and developed in such a way as to ensure that their operation is sufficiently transparent to enable…

1. High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine interface tools, that they can be…

1. High-risk AI systems shall be designed and developed in such a way that they achieve an appropriate level of accuracy, robustness, and…

Providers of high-risk AI systems shall:

1. Providers of high-risk AI systems shall put a quality management system in place that ensures compliance with this Regulation. That system shall…

1. The provider shall, for a period ending 10 years after the high-risk AI system has been placed on the market or put into service, keep at the…

1. Providers of high-risk AI systems shall keep the logs referred to in Article 12(1), automatically generated by their high-risk AI systems, to the…

1. Providers of high-risk AI systems which consider or have reason to consider that a high-risk AI system that they have placed on the market or put…

1. Providers of high-risk AI systems shall, upon a reasoned request by a competent authority, provide that authority all the information and…

1. Prior to making their high-risk AI systems available on the Union market, providers established in third countries shall, by written mandate…

1. Before placing a high-risk AI system on the market, importers shall ensure that the system is in conformity with this Regulation by verifying that:

1. Before making a high-risk AI system available on the market, distributors shall verify that it bears the required CE marking, that it is…

1. Any distributor, importer, deployer or other third-party shall be considered to be a provider of a high-risk AI system for the purposes of this…

1. Deployers of high-risk AI systems shall take appropriate technical and organisational measures to ensure they use such systems in accordance with…

1. Prior to deploying a high-risk AI system referred to in Article 6(2), with the exception of high-risk AI systems intended to be used in the area…

1. Each Member State shall designate or establish at least one notifying authority responsible for setting up and carrying out the necessary…

1. Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member State in which they are…

1. Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 31.

1. A notified body shall be established under the national law of a Member State and shall have legal personality.

Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the…

1. Where a notified body subcontracts specific tasks connected with the conformity assessment or has recourse to a subsidiary, it shall ensure that…

1. Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment procedures set out in Article 43.

1. The Commission shall assign a single identification number to each notified body, even where a body is notified under more than one Union act.

1. The notifying authority shall notify the Commission and the other Member States of any relevant changes to the notification of a notified body via…

1. The Commission shall, where necessary, investigate all cases where there are reasons to doubt the competence of a notified body or the continued…

1. The Commission shall ensure that, with regard to high-risk AI systems, appropriate coordination and cooperation between notified bodies active in…

Conformity assessment bodies established under the law of a third country with which the Union has concluded an agreement may be authorised to carry…

1. High-risk AI systems or general-purpose AI models which are in conformity with harmonised standards or parts thereof the references of which have…

1. The Commission may adopt, implementing acts establishing common specifications for the requirements set out in Section 2 of this Chapter or, as…

1. High-risk AI systems that have been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting…

1. For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating the compliance of a high-risk AI system with the requirements set…

1. Certificates issued by notified bodies in accordance with Annex VII shall be drawn-up in a language which can be easily understood by the relevant…

1. Notified bodies shall inform the notifying authority of the following:

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…

1. The provider shall draw up a written machine readable, physical or electronically signed EU declaration of conformity for each high-risk AI…

1. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

1. Before placing on the market or putting into service a high-risk AI system listed in Annex III, with the exception of high-risk AI systems…