+Artigo 30.o Regras e condições para a aposição da marcação CE
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Artigo 30.o Regras e condições para a aposição da marcação CE

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1. Visão geral

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Artigo 30.o 1.
A marcação CE deve ser aposta de modo visível, legível e indelével no produto com elementos digitais. Caso tal não seja possível ou não se justifique devido à natureza do produto com elementos digitais, a marcação CE deve ser aposta na embalagem e na declaração de conformidade UE referida no artigo 28.o que acompanha o produto com elementos digitais. No caso dos produtos com elementos digitais sob a forma de software, a marcação CE deve ser aposta na declaração de conformidade UE referida no artigo 28.o ou no sítio Web que acompanha o produto de software. Neste último caso, a secção pertinente do sítio Web deve ser de acesso fácil e direto para os consumidores.
Artigo 30.o 2.
Tendo em conta a natureza do produto com elementos digitais, a altura da marcação CE aposta no produto com elementos digitais pode ser inferior a 5 mm, desde que continue a ser visível e legível.
Artigo 30.o 3.
A marcação CE deve ser aposta antes de o produto com elementos digitais ser colocado no mercado. Pode ser acompanhada de um pictograma ou de outra marca que indique um risco ou uma utilização especiais em matéria de cibersegurança estabelecidos nos atos de execução referidos no n.o 6.
Artigo 30.o 4.
A marcação CE deve ser acompanhada do número de identificação do organismo notificado, sempre que este intervenha no procedimento de avaliação da conformidade baseada na garantia de qualidade total (baseado no módulo H) referido no artigo 32.o.

O número de identificação do organismo notificado é aposto pelo próprio organismo ou, segundo as suas instruções, pelo fabricante ou pelo seu mandatário.
Artigo 30.o 5.
Os Estados-Membros devem basear-se nos mecanismos existentes para assegurarem a correta aplicação do regime que rege a marcação CE e devem tomar as medidas adequadas em caso de utilização indevida dessa marcação. Caso o produto com elementos digitais seja objeto de outra legislação de harmonização da União distinta do presente regulamento que também preveja a aposição da marcação CE, a marcação deve indicar que o produto cumpre igualmente os requisitos definidos nessa outra legislação de harmonização da União.
Artigo 30.o 6.
A Comissão pode estabelecer, por meio de atos de execução, especificações técnicas para os rótulos, pictogramas ou quaisquer outras marcas relacionadas com a segurança dos produtos com elementos digitais, bem como os seus períodos de apoio e mecanismos para promover a sua utilização e aumentar a sensibilização do público para a segurança dos produtos com elementos digitais. Ao elaborar os projetos de atos de execução, a Comissão consulta as partes interessadas pertinentes e, se já tiver sido criado nos termos do artigo 52.o, n.o 15, o ADCO. Os referidos atos de execução são adotados pelo procedimento de exame a que se refere o artigo 62.o, n.o 2.

1.1 Referências

1.2 Requisitos identificados

1.3 Normas relacionadas

2. Requisitos identificados

Requisitos

3. Normas relacionadas

Normas
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.