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Article 85 of 11375%

Article 85: Right to lodge a complaint with a market surveillance authority

EU Official:
Title IX: Codes of Conduct & Guidelines

Official text

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Source: EUR-Lex, Regulation (EU) 2024/1689 — text reproduced verbatim.

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Frequently asked questions

Can I file a complaint about an AI system under Article 85?
Yes, Article 85 gives any natural or legal person the right to lodge a complaint with the market surveillance authority if they believe the AI Act has been infringed.
Do SMEs also need to comply with Article 85 of the AI Act?
Article 85 of the AI Act does not provide a general exemption for SMEs. However, the AI Act includes supportive measures and potentially lighter obligations for small and medium-sized enterprises, depending on their role in the AI value chain.
How does Article 85 of the AI Act relate to the GDPR?
Article 85 of the AI Act complements the GDPR. While the GDPR protects personal data, the AI Act focuses on the safety and trustworthiness of AI systems. Organisations must comply with both regulations when their AI system processes personal data.
What are the deadlines for Article 85 of the AI Act?
The AI Act follows a phased implementation. Prohibited AI practices apply from February 2025, obligations for high-risk AI systems from August 2026, and other provisions take effect gradually. The specific deadline for Article 85 depends on the category of the obligation.
Does Article 85 of the AI Act also apply to AI systems I purchase?
Yes, Article 85 of the AI Act may also be relevant when you purchase AI systems. As a deployer, you have your own obligations under the AI Act, regardless of whether you developed the system yourself or purchased it from a provider.
What is the difference between provider and deployer under Article 85 of the AI Act?
Under Article 85 of the AI Act, the provider is the entity that develops or places the AI system on the market, while the deployer is the entity that uses the system under its own authority. Both roles carry different obligations.
What documentation does Article 85 of the AI Act require?
Article 85 of the AI Act requires that relevant documentation is maintained as part of the compliance process. This may include technical documentation, instructions for use, logs or declarations of conformity, depending on the classification of the AI system.
How do I document compliance with Article 85 of the AI Act?
You document compliance with Article 85 of the AI Act by establishing a risk management system, maintaining technical documentation, and conducting internal audits. Keep all relevant documents for the period prescribed by the AI Act.

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