Article 83: Formal non-compliance
| 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:
(a)
the CE marking has been affixed in violation of Article 48;
(b)
the CE marking has not been affixed;
(c)
the EU declaration of conformity referred to in Article 47 has not been drawn up;
(d)
the EU declaration of conformity referred to in Article 47 has not been drawn up correctly;
(e)
the registration in the EU database referred to in Article 71 has not been carried out;
(f)
where applicable, no authorised representative has been appointed;
(g)
technical documentation is not available. |
| 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to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.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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