1. Providers of high-risk AI systems placed on the Union market shall report any serious incident to the market surveillance authorities of the Member States where that incident occurred.
Such notification shall be made immediately after the provider has established a causal link between the AI system and the serious incident or the reasonable likelihood of such a link, and, in any event, not later than 15 days after the providers becomes aware of the serious incident.
2. Upon receiving a notification related to a serious incident referred to in Article 3(44)(c), the relevant market surveillance authority shall inform the national public authorities or bodies referred to in Article 64(3). The Commission shall develop dedicated guidance to facilitate compliance with the obligations set out in paragraph 1. That guidance shall be issued 12 months after the entry into force of this Regulation, at the latest.
3. For high-risk AI systems referred to in point 5 of Annex III which are placed on the market or put into service by providers that are financial institutions that are subject to requirements regarding their internal governance, arrangements or processes under Union financial services legislation, the notification of serious incidents shall be limited to those referred to in Article 3(44)(c).
4. For high-risk AI systems which are safety components of devices, or are themselves devices, covered by Regulation (EU) 2017/745 and Regulation (EU) 2017/746 the notification of serious incidents shall be limited to those referred to in Article 3(44)(c) and be made to the national competent authority chosen for this purpose by the Member States where that incident occurred.
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