Notifying authorities

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 notification of conformity assessment bodies and for their monitoring. Those procedures shall be developed in cooperation between the notifying authorities of all Member States.

2. Member States may decide that the assessment and monitoring referred to in paragraph 1 is to be carried out by a national accreditation body within the meaning of, and in accordance with, Regulation (EC) No 765/2008.

3. Notifying authorities shall be established, organised and operated in such a way that no conflict of interest arises with conformity assessment bodies, and that the objectivity and impartiality of their activities are safeguarded.

4. Notifying authorities shall be organised in such a way that decisions relating to the notification of conformity assessment bodies are taken by competent persons different from those who carried out the assessment of those bodies.

5. Notifying authorities shall offer or provide neither any activities that conformity assessment bodies perform, nor any consultancy services on a commercial or competitive basis.

6. Notifying authorities shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.

7. Notifying authorities shall have an adequate number of competent personnel at their disposal for the proper performance of their tasks. Competent personnel shall have the necessary expertise, where applicable, for their function, in fields such as information technologies, AI and law, including the supervision of fundamental rights.

8. Notifying authorities designated pursuant to this Regulation that are responsible for AI systems covered by the Union harmonisation legislation listed in Section A of Annex I shall ensure that the conformity assessment body that applies for designation both pursuant to this Regulation and the Union harmonisation legislation listed in Section A of Annex I is provided with the possibility to submit a single application and undergoes a unified assessment procedure to be designated pursuant to this Regulation and Union harmonisation legislation listed in Section A of Annex I, where the relevant Union harmonisation legislation provides for such single application and unified assessment procedure. To that end, notifying authorities designated pursuant to this Regulation and those designated pursuant to the Union harmonisation legislation listed in Section A of Annex I shall cooperate in their assessments.

The single application and the unified assessment procedure referred to in this paragraph shall also be made available to notified bodies already designated pursuant to the Union harmonisation legislation listed in Section A of Annex I, when those notified bodies apply for designation pursuant to this Regulation, provided that the relevant Union harmonisation legislation provides for such a procedure.

A conformity assessment body that is designated pursuant to more than one piece of Union harmonisation legislation listed in Section A of Annex I shall have to apply only once to be designated pursuant to this Regulation. A designation pursuant to this Regulation shall be applicable for all Union harmonisation legislation listed in Section A of Annex I for which the conformity assessment body is designated.

The single application and the unified assessment procedure shall avoid any unnecessary duplications, build on the existing procedures for designation in accordance with the Union harmonisation legislation listed in Section A of Annex I and ensure compliance with the requirements relating to notified bodies both in accordance with this Regulation and the relevant Union harmonisation legislation.

9. A notifying authority that has been designated pursuant to the Union harmonisation legislation listed in Section A of Annex I is also the notifying authority for the application of the single application and unified assessment procedure referred to in paragraph 8, unless the Member State designates another notifying authority for this Regulation.