must put a quality management system in place that ensures compliance with this Regulation.
must enable its authorised representative to perform the tasks specified in the mandate received from the provider.
must closely cooperate with new providers and make available necessary information and provide technical access and other assistance
must register themselves and their system in the EU database referred to in Article 71.
Deadline: Before placing on the market or putting into service
must register themselves and that system in the EU database referred to in Article 71.
Deadline: Before placing on the market or putting into service
must remain liable under applicable Union and national liability law for any damage inflicted on third parties as a result of the experimentation taking place in the sandbox.
must draw up a real-world testing plan and submit it to the market surveillance authority.
must register the testing in real world conditions with a Union-wide unique single identification number and with the information specified in Annex IX.
must ensure that data collected and processed for the purpose of the testing in real world conditions is transferred to third countries only provided that appropriate and applicable safeguards under Union law are implemented.
must ensure that the testing in real world conditions does not last longer than necessary.
must give a copy of the dated and documented informed consent to the subjects of testing or their legal representative
must report any serious incident to the market surveillance authorities of the Member States where that incident occurred.
Deadline: immediately after establishing a causal link or reasonable likelihood of such a link, and no later than 15 days after becoming aware
must report a serious incident in the event of a widespread infringement or a serious incident as defined in Article 3, point (49)(b) immediately, and not later than two days after becoming aware.
Deadline: immediately, and not later than two days after becoming aware
must report a serious incident in the event of the death of a person immediately after establishing or suspecting a causal relationship, but not later than 10 days after becoming aware.
Deadline: immediately after establishing or suspecting a causal relationship, but not later than 10 days after becoming aware
must ensure that all necessary action is taken to bring the AI system into compliance with the requirements and obligations laid down in this Regulation.
must supply the information requested by the Commission.
Deadline: within a period specified by the Commission
must supply the information requested on behalf of the provider of the general-purpose AI model.
must supply the information requested by the Commission.
must provide access to the general-purpose AI model concerned through APIs or further appropriate technical means and tools.
Deadline: within the period set by the Commission
must lodge an application with a notified body of their choice for the assessment of the technical documentation relating to the AI system.
must include the name and address of the provider in the application.
must include a written declaration that the same application has not been lodged with any other notified body in the application.
must include the technical documentation referred to in Annex IV in the application.
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