Article 108

Amendment to Regulation (EU) 2018/1139

Updated on 31 July 2024 based on the version published in the Official Journal of the EU dated 12 July 2024 and entered into force on 1 August 2024.

Regulation (EU) 2018/1139 is amended as follows:

(1) in Article 17, the following paragraph is added:

‘3.   Without prejudice to paragraph 2, when adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council (*7), the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.

(2) in Article 19, the following paragraph is added:

‘4.   When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’

;

(3) in Article 43, the following paragraph is added:

‘4.   When adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’

;

(4) in Article 47, the following paragraph is added:

‘3.   When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’

;

(5) in Article 57, the following subparagraph is added:

‘When adopting those implementing acts concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’

;

(6) in Article 58, the following paragraph is added:

‘3.   When adopting delegated acts pursuant to paragraphs 1 and 2 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689, the requirements set out in Chapter III, Section 2, of that Regulation shall be taken into account.’.


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*7Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj).’;”

Table of Contents

Chapter III: High-Risk AI Systems
Chapter IX: Post-Market Monitoring, Information Sharing and Market Surveillance