Section 5Standards, conformity assessment, certificates, registration

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 been published in the Official…

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

1. High-risk AI systems that have been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting within which they are intended to be…

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 out…

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 authorities in the…

1. Notified bodies shall inform the notifying authority of the following: (a) any Union technical documentation assessment certificates, any supplements to those certificates, and any quality management system…

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…

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

1. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008 . 2. For high-risk AI systems provided…

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 referred to…