HIGH-RISK AI SYSTEMS

1. Irrespective of whether an AI system is placed on the market or put into service independently of the products referr…

1. The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend Annex III by adding or mod…

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

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

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

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

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

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

1. High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine interfac…

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

Providers of high-risk AI systems shall: (a) ensure that their high-risk AI systems are compliant with the requirements …

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

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

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

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

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

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

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

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

1. Any distributor, importer, deployer or other third-party shall be considered to be a provider of a high-risk AI syste…

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

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

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

1. Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member St…

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

1. A notified body shall be established under the national law of a Member State and shall have legal personality. 2. No…

Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised st…

1. Where a notified body subcontracts specific tasks connected with the conformity assessment or has recourse to a subsi…

1. Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment proc…

1. The Commission shall assign a single identification number to each notified body, even where a body is notified under…

1. The notifying authority shall notify the Commission and the other Member States of any relevant changes to the notifi…

1. The Commission shall, where necessary, investigate all cases where there are reasons to doubt the competence of a not…

1. The Commission shall ensure that, with regard to high-risk AI systems, appropriate coordination and cooperation betwe…

Conformity assessment bodies established under the law of a third country with which the Union has concluded an agreemen…

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

1. The Commission may adopt, implementing acts establishing common specifications for the requirements set out in Sectio…

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

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

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

1. Notified bodies shall inform the notifying authority of the following: (a) any Union technical documentation assessme…

1. By way of derogation from Article 43 and upon a duly justified request, any market surveillance authority may authori…

1. The provider shall draw up a written machine readable, physical or electronically signed EU declaration of conformity…

1. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008. 2. Fo…

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