Article 83 Formal non-compliance

1. the CE marking means a marking by which a manufacturer indicates that a product with digital elements and the processes put in place by the manufacturer are in conformity with the essential cybersecurity requirements set out in Annex I and other applicable Union harmonisation legislation providing for its affixing; has been affixed in violation of Article 48;

2. the CE marking means a marking by which a manufacturer indicates that a product with digital elements and the processes put in place by the manufacturer are in conformity with the essential cybersecurity requirements set out in Annex I and other applicable Union harmonisation legislation providing for its affixing; has not been affixed;

3. the EU declaration of conformity referred to in Article 47 has not been drawn up;

4. the EU declaration of conformity referred to in Article 47 has not been drawn up correctly;

5. the registration in the EU database referred to in Article 71 has not been carried out;

6. where applicable, no authorised representative means a natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks; has been appointed;

7. technical documentation is not available.

Where the non-compliance referred to in paragraph 1 persists, the market surveillance authority means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020; 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to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.