Summary of Article 28
- Establishment and Designation of Notifying Authorities: Member States must designate or establish notifying authorities to oversee the assessment, designation, notification, and monitoring of conformity assessment bodies, which can also be carried out by national accreditation bodies.
- Independence, Impartiality, and Confidentiality: Notifying authorities must avoid conflicts of interest, ensure impartiality in decision-making, refrain from providing conformity assessment services, and safeguard the confidentiality of all obtained information.
- Competence and Personnel Requirements: Notifying authorities must employ sufficient competent personnel with expertise in relevant fields such as IT, AI, law, and fundamental rights supervision to effectively perform their tasks.
Establishment and Designation of 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.
Independence, Impartiality, and Confidentiality
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.
Competence and Personnel Requirements
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.
