Providers must lodge an application with a notified body of their choice for the assessment of the technical documentation relating to the AI system.
an application with a notified body of their choice shall be lodged by the provider for the assessment of the technical documentation relating to the AI system which the provider intends to place on the market or put into service and which is covered by the quality management system referred to under point 3.
Providers must include the name and address of the provider in the application.
(a)
the name and address of the provider;
Providers must include a written declaration that the same application has not been lodged with any other notified body in the application.
(b)
a written declaration that the same application has not been lodged with any other notified body;
Providers must include the technical documentation referred to in Annex IV in the application.
(c)
the technical documentation referred to in Annex IV.
Notified bodies must examine the technical documentation.
The technical documentation shall be examined by the notified body.
Notified bodies must grant full access to the training, validation, and testing data sets used, where relevant.
the notified body shall be granted full access to the training, validation, and testing data sets used, including, where appropriate and subject to security safeguards, through API or other relevant technical means and tools enabling remote access.
Notified bodies must require the provider to supply further evidence or carry out further tests, if necessary.
In examining the technical documentation, the notified body may require that the provider supply further evidence or carry out further tests so as to enable a proper assessment of the conformity of the AI system with the requirements set out in Chapter III, Section 2.
Notified bodies must carry out adequate tests, if necessary.
Where the notified body is not satisfied with the tests carried out by the provider, the notified body shall itself directly carry out adequate tests, as appropriate.
Notified bodies must grant access to the training and trained models of the AI system, including its relevant parameters, upon a reasoned request.
upon a reasoned request, the notified body shall also be granted access to the training and trained models of the AI system, including its relevant parameters
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