+Artículo 30 Reglas y condiciones para la colocación del marcado CE
---+Artículo 30 1.
---+Artículo 30 2.
---+Artículo 30 3.
---+Artículo 30 4.
---+Artículo 30 5.
---+Artículo 30 6.

Artículo 30 Reglas y condiciones para la colocación del marcado CE

-

1. Resumen

,
Artículo 30 1.
El marcado CE se colocará en el producto con elementos digitales de manera visible, legible e indeleble. Cuando ello no sea posible o no se justifique dada la naturaleza del producto con elementos digitales, se colocará en el embalaje y en la declaración UE de conformidad mencionada en el artículo 28 que acompañen al producto con elementos digitales. En el caso de los productos con elementos digitales en forma de programas informáticos, el marcado CE se colocará en la declaración UE de conformidad mencionada en el artículo 28 o el sitio web que acompañen al producto. En este último caso, los consumidores deberán poder acceder de manera sencilla y directa al apartado pertinente del sitio web.
Artículo 30 2.
Habida cuenta de la naturaleza del producto con elementos digitales, la altura del marcado CE colocado en él podrá ser inferior a 5 mm, siempre y cuando siga siendo visible y legible.
Artículo 30 3.
El marcado CE se colocará antes de que el producto con elementos digitales se introduzca en el mercado. Podrá ir seguido de un pictograma o cualquier otra marca que indique un riesgo o uso de ciberseguridad especiales establecidos en los actos de ejecución a que se refiere el apartado 6.
Artículo 30 4.
El marcado CE irá seguido del número de identificación del organismo notificado cuando dicho organismo participe en el procedimiento de evaluación de la conformidad basado en el aseguramiento de calidad total (basado en el módulo H) a que hace referencia el artículo 32.

Dicho número de identificación del organismo notificado será colocado por el propio organismo notificado o bien, siguiendo las instrucciones de este, por el fabricante o por el representante autorizado de este.
Artículo 30 5.
Los Estados miembros se basarán en los mecanismos existentes para garantizar la correcta aplicación del régimen que regula el marcado CE y adoptarán las medidas adecuadas en caso de uso indebido de dicho marcado. Cuando al producto con elementos digitales se aplique otra legislación de armonización de la Unión distinta del presente Reglamento que también requiera la colocación del marcado CE, el marcado CE indicará que el producto también cumple los requisitos establecidos en esa otra legislación de armonización de la Unión.
Artículo 30 6.
La Comisión podrá, mediante actos de ejecución, establecer especificaciones técnicas para etiquetas, pictogramas o cualquier otro marcado relativo a la seguridad de los productos con elementos digitales, sus períodos de soporte, así como mecanismos para promover su uso y fomentar la sensibilización pública respecto a la seguridad de los productos con elementos digitales. Al preparar los proyectos de actos de ejecución, la Comisión consultará a las partes interesadas pertinentes y, si ya se ha creado de conformidad con el artículo 52, apartado 15, al ADCO. Dichos actos de ejecución se adoptarán de conformidad con el procedimiento de examen a que se refiere el artículo 62, apartado 2.

1.1 Referencias

1.2 Requisitos identificados

1.3 Estándares relacionados

2. Requisitos identificados

Requisitos

3. Estándares relacionados

Estándares
SCF Product Management

Description

Mechanisms exist to design and implement product management processes to proactively govern the design, development and production of Technology Assets, Applications and/or Services (TAAS) across the System Development Life Cycle (SDLC) to:
(1) Improve functionality;
(2) Enhance security and resiliency capabilities;
(3) Correct security deficiencies; and
(4) Conform with applicable statutory, regulatory and/or contractual obligations.

Possible Solutions & Considerations

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

∙ Defined business processes
∙ Product / project management
∙ Defined technical requirements
∙ Defined business requirements

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

∙ Defined business processes
∙ Product / project management
∙ Defined technical requirements
∙ Defined business requirements

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

∙ Defined business processes
∙ Product / project management
∙ Defined technical requirements
∙ Defined business requirements
∙ System Development Lifecycle (SDLC) governance / oversight

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

∙ Defined business processes
∙ Product / project management
∙ Defined technical requirements
∙ Defined business requirements
∙ System Development Lifecycle (SDLC) governance / oversight

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

∙ Defined business processes
∙ Product / project management
∙ Defined technical requirements
∙ Defined business requirements
∙ System Development Lifecycle (SDLC) governance / oversight

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

Technology Development & Acquisition (TDA) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with TDA domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ Technology development & acquisition-related activities are decentralized (e.g., a localized/regionalized function) and uses non-standardized methods to implement secure, resilient and compliant practices.
▪ Secure development practices loosely conform to industry-recognized standards for secure engineering (e.g., OWASP, NIST SP 800-218 and NIST SP 800-160).
▪ IT and/or cybersecurity personnel use an informal process to govern changes to the software library to prevent unauthorized changes and create an audit trail of changes made.

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.
▪ Development and acquisition management is decentralized (e.g., a localized/regionalized function) and uses non-standardized methods to implement secure, resilient and compliant practices.

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 design and implement product management processes to proactively govern the design, development and production of Technology Assets, Applications and/or Services (TAAS) across the System Development Life Cycle (SDLC) to:
(1) Improve functionality;
(2) Enhance security and resiliency capabilities;
(3) Correct security deficiencies; and
(4) Conform with applicable statutory, regulatory and/or contractual obligations.

Level 4 Quantitatively Controlled

Technology Development & Acquisition (TDA) capabilities, in addition to being standardized across the entity and centrally managed to ensure consistency across Technology Assets, Applications, Services and/or Data (TAASD), efforts are metrics driven to provide sufficient insight for decision makers to predict optimal performance, ensure continued operations and/or identify areas for improvement. Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Applicable SCR-CMM Level 3 (Well Defined) capabilities are implemented and operational.
▪ Metrics reporting includes quantitative analysis of Key Performance Indicators (KPIs).
▪ Metrics reporting includes quantitative analysis of Key Risk Indicators (KRIs).
▪ Scope of metrics, KPIs and KRIs covers organization-wide cybersecurity and data protection controls, including functions performed by third-parties.
▪ Organizational leadership maintains a formal process to objectively review and respond to metrics, KPIs and KRIs (e.g., monthly or quarterly review).
▪ Based on metrics analysis, process improvement recommendations are submitted for review and are handled in accordance with change control processes.
▪ Business and technical stakeholders are involved in reviewing and approving proposed changes to evolve capabilities.

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.