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Article 58

Detailed arrangements for, and functioning of, AI regulatory sandboxes

https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32024R1689#art_58 ↗
European Commission Article 58(2)(a) Deadline: within three months of the application

The Commission must ensure that AI regulatory sandboxes are open to any applying provider or prospective provider of an AI system who fulfils eligibility and selection criteria.

Show source text · Article 58(2)(a)
(a)
that AI regulatory sandboxes are open to any applying provider or prospective provider of an AI system who fulfils eligibility and selection criteria, which shall be transparent and fair, and that national competent authorities inform applicants of their decision within three months of the application;
European Commission Article 58(2)(b)

The Commission must ensure that AI regulatory sandboxes allow broad and equal access and keep up with demand for participation.

Show source text · Article 58(2)(b)
(b)
that AI regulatory sandboxes allow broad and equal access and keep up with demand for participation; providers and prospective providers may also submit applications in partnerships with deployers and other relevant third parties;
European Commission Article 58(2)(c)

The Commission must ensure that the detailed arrangements for, and conditions concerning AI regulatory sandboxes support flexibility for national competent authorities.

Show source text · Article 58(2)(c)
(c)
that the detailed arrangements for, and conditions concerning AI regulatory sandboxes support, to the best extent possible, flexibility for national competent authorities to establish and operate their AI regulatory sandboxes;
European Commission Article 58(2)(d)

The Commission must ensure that access to the AI regulatory sandboxes is free of charge for SMEs, including start-ups.

Show source text · Article 58(2)(d)
(d)
that access to the AI regulatory sandboxes is free of charge for SMEs, including start-ups, without prejudice to exceptional costs that national competent authorities may recover in a fair and proportionate manner;
European Commission Article 58(2)(e)

The Commission must facilitate providers and prospective providers in complying with conformity assessment obligations.

Show source text · Article 58(2)(e)
(e)
that they facilitate providers and prospective providers, by means of the learning outcomes of the AI regulatory sandboxes, in complying with conformity assessment obligations under this Regulation and the voluntary application of the codes of conduct referred to in Article 95;
European Commission Article 58(2)(f)

The Commission must facilitate the involvement of other relevant actors within the AI ecosystem.

Show source text · Article 58(2)(f)
(f)
that AI regulatory sandboxes facilitate the involvement of other relevant actors within the AI ecosystem, such as notified bodies and standardisation organisations, SMEs, including start-ups, enterprises, innovators, testing and experimentation facilities, research and experimentation labs and European Digital Innovation Hubs, centres of excellence, individual researchers, in order to allow and facilitate cooperation with the public and private sectors;
European Commission Article 58(2)(g)

The Commission must ensure that procedures, processes and administrative requirements for application, selection, participation and exiting the AI regulatory sandbox are simple and easily intelligible.

Show source text · Article 58(2)(g)
(g)
that procedures, processes and administrative requirements for application, selection, participation and exiting the AI regulatory sandbox are simple, easily intelligible, and clearly communicated in order to facilitate the participation of SMEs, including start-ups, with limited legal and administrative capacities and are streamlined across the Union, in order to avoid fragmentation and that participation in an AI regulatory sandbox established by a Member State, or by the European Data Protection Supervisor is mutually and uniformly recognised and carries the same legal effects across the Union

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