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Article 83 — Formal non-compliance

Digital & dataLevel 1RegulationAI ActIn forceOfficial source

83(1)

1.Where the market surveillance authority of a Member State makes one of the following findings, it shall require the relevant provider to put an end to the non-compliance concerned, within a period it may prescribe:

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83(1)(a)
(a)the CE marking has been affixed in violation of Article 48;
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83(1)(b)
(b)the CE marking has not been affixed;
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83(1)(c)
(c)the EU declaration of conformity referred to in Article 47 has not been drawn up;
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83(1)(d)
(d)the EU declaration of conformity referred to in Article 47 has not been drawn up correctly;
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83(1)(e)
(e)the registration in the EU database referred to in Article 71 has not been carried out;
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83(1)(f)
(f)where applicable, no authorised representative has been appointed;
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83(1)(g)
(g)technical documentation is not available.
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83(2)

2.Where the non-compliance referred to in paragraph 1 persists, the market surveillance authority of the Member State concerned shall take appropriate and proportionate measures to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.

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