BETA

3 Amendments of Deirdre CLUNE related to 2022/0272(COD)

Amendment 89 #
Proposal for a regulation
Recital 29
(29) Products with digital elements classified as high-risk AI systems according to Article 6 of Regulation27 [the AI Regulation] which fall within the scope of this Regulation should comply with the essential requirements set out in this Regulation. When those high-risk AI systems fulfil the essential requirements of this Regulation, they should be deemed compliant with the cybersecurity requirements set out in Article [Article 15] of Regulation [the AI Regulation] in so far as those requirements are covered by the EU declaration of conformity or parts thereof issued under this Regulation. As regards the conformity assessment procedures relating to the essential cybersecurity requirements of a product with digital elements covered by this Regulation and classified as a high-risk AI system, the relevant provisions of Article 43 of Regulation [the AI Regulation] should apply as a rule instead of the respective provisions of this Regulation. However, tThis rule should not result in reducing the necessarycreate a high level of assurance for critical products with digital elements covered by this Regulation. Therefore, by way of derogation from this rule,For high- risk AI systems that fall within the scope of the Regulation [the AI Regulation] and are also qualified as critical products with digital elements pursuant tounder this Regulation and to which the conformity assessment procedure based on internal control referred to in Annex VI of the Regulation [the AI Regulation] applies, should be subject to, the responsible sectoral notified body should be responsible for conducting the conformity assessment provisions ofunder this Regulation in so far as the essential requirements of this Regulation are concerned. In this case, for all the other aspects covered by Regulation [the AI Regulation] the respective provisions on conformity assessment based on internal control set out in Annex VI to Regulation [the AI Regulation] should appland lead the administrative process such that economic operators can address their request for conformity assessment to a single regulatory body. __________________ 27 Regulation [the AI Regulation].
2023/04/28
Committee: IMCO
Amendment 165 #
Proposal for a regulation
Article 8 – paragraph 2
2. For the products and cybersecurity requirements referred to in paragraph 1, the relevant conformity assessment procedure as required by Article [Article 43] ofthe [applicable provisions] Regulation [AI Regulation] shall apply. For the purpose of that assessment, notified bodies which are entitled to control the conformity of the high-risk AI systems under the Regulation [AI Regulation] shall be also entitled to control the conformity of the high-risk AI systems within the scope of this Regulation with the requirements set out in Annex I to this Regulation, provided that the compliance of those notified bodies with the requirements laid down in Article 29 of this Regulation have been assessed in the context of the notification procedure under Regulation [AI Regulation].
2023/04/28
Committee: IMCO
Amendment 166 #
Proposal for a regulation
Article 8 – paragraph 3
3. By derogation from paragraph 2, critical products with digital elements listed in Annex III of this Regulation, which have to apply the conformity assessment procedures referred to in Articles 24(2)(a), 24(2)(b), 24(3)(a) and 24(3)(b) under this Regulation and which are also classified as high-risk AI systems according to Article [Article 6] of the Regulation [AI Regulation] and to which the conformity assessment procedure based on internal control referred to in Annex [Annex VI] to Regulation [the AI Regulation] applies, shall be subject to the conformity assessment procedures as required by this Regulation in so far as the essential requirements of this Regulation are concerned.deleted
2023/04/28
Committee: IMCO