Section 4Notifying authorities and notified bodies

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

1. Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member State in which they are established. 2. The application for notification…

1. Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 31 . 2. Notifying authorities shall notify the Commission and…

1. A notified body shall be established under the national law of a Member State and shall have legal personality. 2. Notified bodies shall satisfy the organisational, quality…

Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published…

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

1. Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment procedures set out in Article 43 . 2. Notified bodies shall…

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. 2. The Commission…

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 the electronic notification…

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

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

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