Article 80 — Procedure for Dealing with AI Systems Classified as Presenting a Risk

Article 80
Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III

1. Where a market surveillance authority has sufficient reason to consider that an AI system classified by the provider as
non-high-risk pursuant to Article 6(3) is indeed high-risk, the market surveillance authority shall carry out an evaluation of
the AI system concerned in respect of its classification as a high-risk AI system based on the conditions set out in Article
6(3) and the Commission guidelines.

ELI: http://data.europa.eu/eli/reg/2024/1689/oj 107/144
EN OJ L, 12.7.2024

2. Where, in the course of that evaluation, the market surveillance authority finds that the AI system concerned is
high-risk, it shall without undue delay require the relevant provider to take all necessary actions to bring the AI system into
compliance with the requirements and obligations laid down in this Regulation, as well as take appropriate corrective action
within a period the market surveillance authority may prescribe.

3. Where the market surveillance authority considers that the use of the AI system concerned is not restricted to its

national territory, it shall inform the Commission and the other Member States without undue delay of the results of the
evaluation and of the actions which it has required the provider to take.

4. The provider shall ensure that all necessary action is taken to bring the AI system into compliance with the
requirements and obligations laid down in this Regulation. Where the provider of an AI system concerned does not bring
the AI system into compliance with those requirements and obligations within the period referred to in paragraph 2 of this
Article, the provider shall be subject to fines in accordance with Article 99.

5. The provider shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that
it has made available on the Union market.

6. Where the provider of the AI system concerned does not take adequate corrective action within the period referred to
in paragraph 2 of this Article, Article 79(5) to (9) shall apply.

7. Where, in the course of the evaluation pursuant to paragraph 1 of this Article, the market surveillance authority
establishes that the AI system was misclassified by the provider as non-high-risk in order to circumvent the application of
requirements in Chapter III, Section 2, the provider shall be subject to fines in accordance with Article 99.

8. In exercising their power to monitor the application of this Article, and in accordance with Article 11 of Regulation
(EU) 2019/1020, market surveillance authorities may perform appropriate checks, taking into account in particular
information stored in the EU database referred to in Article 71 of this Regulation.