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Article 58 — Formal non-compliance

Digital & dataLevel 1RegulationCRAIn forceOfficial source

58(1)

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

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58(1)(a)
(a)the CE marking has been affixed in violation of Articles 29 and 30;
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58(1)(b)
(b)the CE marking has not been affixed;
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58(1)(c)
(c)the EU declaration of conformity has not been drawn up;
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58(1)(d)
(d)the EU declaration of conformity has not been drawn up correctly;
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58(1)(e)
(e)the identification number of the notified body which is involved in the conformity assessment procedure, where applicable, has not been affixed;
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58(1)(f)
(f)the technical documentation is either not available or not complete.
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58(2)

2.Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the product with digital elements from being made available on the market or ensure that it is recalled or withdrawn from the market.

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