+Artikel 111 Reeds in de handel gebrachte of in gebruik gestelde AI-systemen
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Artikel 111 Reeds in de handel gebrachte of in gebruik gestelde AI-systemen

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1. Overzicht

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Artikel 111 1.
Onverminderd de toepassing van artikel 5 als bedoeld in artikel 113, lid 3, punt a), worden AI-systemen die componenten zijn van de bij de in bijlage X vermelde rechtshandelingen opgezette grootschalige IT-systemen die vóór 2 augustus 2027 in de handel zijn gebracht of in gebruik zijn gesteld, uiterlijk op 31 december 2030 in overeenstemming met deze verordening gebracht.

De in deze verordening vastgelegde eisen worden in aanmerking genomen bij de evaluatie van elk volgens de in bijlage X vermelde rechtshandelingen opgezet grootschalig IT-systeem die moet worden uitgevoerd zoals bepaald in die rechtshandelingen en wanneer die rechtshandelingen worden vervangen of gewijzigd.
Artikel 111 2.
Onverminderd de toepassing van artikel 5 als bedoeld in artikel 113, derde alinea, punt a), is deze verordening alleen van toepassing op operatoren van AI-systemen met een hoog risico, met uitzondering van de in lid 1 van dit artikel bedoelde systemen, die vóór de in artikel 113 vermelde toepassingsdatum voor hoofdstuk III in de handel zijn gebracht of in gebruik zijn gesteld, indien die systemen vanaf die datum aanzienlijke wijzigingen in hun ontwerp ondergaan. In ieder geval ondernemen de aanbieders en gebruiksverantwoordelijken van AI-systemen met een hoog risico die bedoeld zijn om door overheidsinstanties te worden gebruikt, de nodige stappen om uiterlijk op 2 augustus 2030 aan de eisen en verplichtingen van deze verordening te voldoen.
Artikel 111 3.
Aanbieders van AI-modellen voor algemene doeleinden die vóór 2 augustus 2025 in de handel zijn gebracht, ondernemen de nodige stappen om uiterlijk op 2 augustus 2027 aan de verplichtingen van deze verordening te voldoen.
Artikel 111 4.
Aanbieders van AI-systemen, met inbegrip van AI-systemen voor algemene doeleinden, die synthetische audio-, beeld-, video- of tekstinhoud genereren en vóór 2 augustus 2026 in de handel zijn gebracht, nemen de nodige stappen om uiterlijk op 2 december 2026 aan artikel 50, lid 2, te voldoen.

1.1 Referenties

1.2 Geïdentificeerde eisen

1.3 Gerelateerde standaarden

2. Geïdentificeerde eisen

Eisen

3. Gerelateerde standaarden

Standaarden
SCF Product Conformity Governance

Description

Mechanisms exist to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's:
(1) Use case(s); and
(2) Geographic markets.

Possible Solutions & Considerations

Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2

∙ Identify laws/regulations applicable to any developed products (e.g., privacy, accessibility)

Small Business (10-49 staff) / BLS Firm Size Classes 3-4

∙ Regulatory requirements checklist for product development
∙ Legal review before release

Medium Business (50-249 staff) / BLS Firm Size Classes 5-6

∙ Product compliance requirements defined at project start
∙ Compliance validation before release
∙ Regulatory conformity records

Large Business (250-999 staff) / BLS Firm Size Classes 7-8

∙ Product conformity governance program (statutory, regulatory, certification requirements)
∙ Compliance gates in release management
∙ Conformity documentation (e.g., declarations of conformity)

Enterprise (> 1,000 staff) / BLS Firm Size Class 9

∙ Enterprise product compliance program covering statutory/regulatory conformity (e.g., EU CRA, FDA, UL 2900)
∙ Regulatory affairs and product security integration
∙ Conformity assessment and certification management

SCR-CMM

Level 0 Not Performed

Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed.

Level 1 Performed Informally

SCR-CMM Level 1 criteria definitions are not available for this control:
▪ A reasonable person would conclude this control requires a structured process.
▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality.

Level 2 Planned Tracked

Technology Development & Acquisition (TDA) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are documented and maintained by process owners.
▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Technology development and acquisition-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Technology development and acquisition management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ Secure development practices mostly conform to industry-recognized standards for secure engineering of Technology Assets, Applications and/or Services (TAAS) (e.g., OWASP, NIST SP 800-218 and NIST SP 800-160).
▪ An application development team, or similar function, uses a structured process to design, build and maintain secure configurations for test, development, staging and production environments.

Level 3 Well Defined

Technology Development & Acquisition (TDA) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with TDA domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Standardized Operating Procedures (SOP) associated with TDA domain capabilities are well-documented and kept current by process owners.
▪ A software development team, or similar function, is appropriately staffed and supported to implement and maintain TDA domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of technology development and acquisition management (e.g., project management software, software escrow solution and software testing tools).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with TDA domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls).
▪ An implemented and operational capability exists to ensure developed Technology Assets, Applications and/or Services (TAAS) conform to applicable statutory and regulatory requirements, based on the product's and/or service's:
(1) Use case(s); and
(2) Geographic markets.

Level 4 Quantitatively Controlled

Utilize SCR-CMM Level 3 criteria definitions:
▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control.
▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define.

Level 5 Continuously Improving

Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.