Conformity Assessment & Certification Procedures for demonstrating compliance: harmonised standards, conformity assessment bodies, notified bodies, CE marking, and EU declarations of conformity
Articles (10) Article 40
Harmonised standards and standardisation deliverables
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…
Article 41
Common specifications
1. The Commission may adopt, implementing acts establishing common specifications for the requirements set out in Section 2 of this Chapter or, as…
Article 42
Presumption of conformity with certain requirements
1. High-risk AI systems that have been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting…
1 recital Article 43
Conformity assessment
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…
Article 44
Certificates
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…
Article 45
Information obligations of notified bodies
1. Notified bodies shall inform the notifying authority of the following: (a) any Union technical documentation assessment certificates, any…
Article 46
Derogation from conformity assessment procedure
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…
Article 47
EU declaration of conformity
1. The provider shall draw up a written machine readable, physical or electronically signed EU declaration of conformity for each high-risk AI…
Article 48
CE marking
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…
Article 49
Section A — Information to be submitted by providers of high-risk AI systems in accordance with Article 49(1)
The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be registered in accordance with…
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