Article 83 Formal non-compliance
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: (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.
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to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.
Drafting History 2 ▾
Case Law 0 ▾
Guidance 1 ▾
2021-04-21
Commission Proposal — COM(2021) 206 final
Article 83 — AI systems already placed on the market or put into service
1. This Regulation shall not apply to the AI systems which are components of the large-scale IT systems established by the legal acts listed in Annex IX that have been placed on the market or put into service before [12 months after the date of application of this Regulation referred to in Article 85(2) ] , unless the replacement or amendment of those legal acts leads to a significant change in the design or intended purpose of the AI system or AI systems concerned. The requirements laid down in this Regulation shall be taken into account, where applicable, in the evaluation of each large-scale IT systems established by the legal acts listed in Annex IX to be undertaken as provided for in those respective acts. 2. This Regulation shall apply to the high-risk AI systems, other than the ones referred to in paragraph 1, that have been placed on the market or put into service before [ date of application of this Regulation referred to in Article 85(2) ], only if, from that date, those systems are subject to significant changes in their design or intended purpose.
July 2024
Final Adopted Text — Regulation (EU) 2024/1689
Article 83 — Formal non-compliance
2 paragraph(s) · Current text shown above
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No case law referencing Article 83 yet.
As courts and enforcement authorities produce decisions interpreting this provision, they will appear here.