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RGPD

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to restrict or prohibit the high-risk AI system being made available on the market or to ensure that it is recalled or withdrawn from the market without delay.

Common Questions

Frequently Asked Questions

What happens if an AI system doesn't have the CE marking?
If an AI system doesn't have the required CE marking, the authority in charge will demand the provider to fix this issue within a specified time frame; if the problem continues, the authority might forbid the sale, restrict availability, or even require the product to be recalled or removed from the market entirely.
What types of non-compliance does Article 83 cover?
Article 83 addresses different types of formal non-compliance related to AI systems, including missing or incorrectly applied CE markings, flawed or missing conformity declarations, lack of required database registration, nonexistent authorized representative appointment, and unavailability of essential technical documents needed to confirm safety and compliance.
Who is responsible for correcting non-compliance according to Article 83?
The provider of the AI system is responsible for correcting any formal non-compliance issues discovered by authorities, such as applying proper CE markings, producing correct EU conformity declarations, registering in the necessary EU database, appointing authorized representatives, and ensuring availability of required technical documentation within the deadline provided.
What happens if providers do not resolve non-compliance issues quickly?
If providers fail to resolve identified compliance problems promptly within the time frame established by the authorities, the responsible market surveillance authority will then implement suitable actions, potentially prohibiting sales, limiting or halting availability, or requiring the AI system to be recalled or withdrawn immediately from the marketplace.
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