Article 63 Derogations for specific operators
1.
1. Microenterprises within the meaning of Recommendation 2003/361/EC may comply with certain elements of the quality management system required by Article 17 of this Regulation in a simplified manner, provided that they do not have partner enterprises or linked enterprises within the meaning of that Recommendation. For that purpose, the Commission shall develop guidelines on the elements of the quality management system which may be complied with in a simplified manner considering the needs of microenterprises, without affecting the level of protection or the need for compliance with the requirements in respect of high-risk AI systems. 2.
2. Paragraph 1 of this Article shall not be interpreted as exempting those operators from fulfilling any other requirements or obligations laid down in this Regulation, including those established in Articles 9, 10, 11, 12, 13, 14, 15, 72 and 73.
Recitals 1 ▾
Drafting History 2 ▾
AI Omnibus 1 ▾
Case Law 0 ▾
Moreover, in light of the very small size of some operators and in order to ensure proportionality regarding costs of innovation, it is appropriate to allow microenterprises to fulfil one of the most costly obligations, namely to establish a quality management system, in a simplified manner which wo…
2021-04-21
Commission Proposal — COM(2021) 206 final
Article 63 — Market surveillance and control of AI systems in the Union market
1. Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. However, for the purpose of the effective enforcement of this Regulation: (a) any reference to an economic operator under Regulation (EU) 2019/1020 shall be understood as including all operators identified in Title III, Chapter 3 of this Regulation; (b) any reference to a product under Regulation (EU) 2019/1020 shall be understood as including all AI systems falling within the scope of this Regulation. 2. The national supervisory authority shall report to the Commission on a regular basis the outcomes of relevant market surveillance activities. The national supervisory authority shall report, without delay, to the Commission and relevant national competition authorities any information identified in the course of market surveillance activities that may be of potential interest for the application of Union law on competition rules. 3. For high-risk AI systems, related to products to which legal acts listed in Annex II, section A apply, the market surveillance authority for the purposes of this Regulation shall be the authority responsible for market surveillance activities designated under those legal acts. 4. For AI systems placed on the market, put into service or used by financial institutions regulated by Union legislation on financial services, the market surveillance authority for the purposes of this Regulation shall be the relevant authority responsible for the financial supervision of those institutions under that legislation. 5. For AI systems listed in point 1(a) in so far as the systems are used for law enforcement purposes, points 6 and 7 of
July 2024
Final Adopted Text — Regulation (EU) 2024/1689
Article 63 — Derogations for specific operators
2 paragraph(s) · Current text shown above
Simplified QMS compliance extended from microenterprises to all SMEs including start-ups
COM(2025) 836 final — AI Omnibus Regulation
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No case law referencing Article 63 yet.
As courts and enforcement authorities produce decisions interpreting this provision, they will appear here.