Notification
Notification is a formal procedure under the EU’s new legislative framework. Product conformity can be assessed by a notified body, and in some cases conformity assessment is obligatory. In order to be able to operate as a notified body, a body has to be verified and recognised as such.
Notifying authorities “notify” (confirm) that a notified body may perform conformity assessment in accordance with an act of EU harmonisation legislation and meets the requirements set out in that legislative act.
Notification in the context of the AI Act means the official communication to the European Commission and the other EU Member States that a conformity assessment body has been verified and designated, as only these notified bodies may perform conformity assessment under the AI Act. In accordance with Article 6 of the AI Act, such notified bodies must be involved if an AI system is considered to be high-risk in order to assess whether the high-risk AI system is in conformity with the requirements of the AI Act.
Notifying authorities
Art. 70 of the AI Act requires at least one notifying authority to be established and designated as a national competent authority.
In accordance with § 3 of the German AI Market Surveillance and Innovation Promotion Act (KI-MIG), there are five notifying authorities in Germany:
- The Federal Office for Information Security (BSI) for high-risk AI as specified in Annex III, No. 1
- The Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) for Annex I, Part A, Nos. 11 and 12
- The Bundesnetzagentur for Annex I, No. 6
- The Bavarian State Ministry of Housing, Building and Transport for safety components for cableway installations (Annex I, No. 8)
- Central Authority of the Federal States for Safety (ZLS) for the other areas of Annex I, Part A
Pursuant to Art. 43(2) and (3), the involvement of a Notified Body is not required for other high-risk AI systems.