+Artikel 30 Regler og betingelser for anbringelse af CE-mærkning
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Artikel 30 Regler og betingelser for anbringelse af CE-mærkning

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1. Oversigt

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Artikel 30 1.
CE-mærkningen anbringes synligt, let læseligt og uudsletteligt på produktet med digitale elementer. Hvis produktet med digitale elementer er af en sådan art, at dette ikke er muligt eller berettiget, anbringes CE-mærkningen på emballagen og på den i artikel 28 omhandlede EU-overensstemmelseserklæring, der ledsager produktet med digitale elementer. For produkter med digitale elementer i form af software anbringes CE-mærkningen enten på den i artikel 28 omhandlede EU-overensstemmelseserklæring eller på webstedet for softwareproduktet. I sidstnævnte tilfælde skal der være nem og direkte adgang for forbrugere til den relevante sektion på webstedet.
Artikel 30 2.
CE-mærkning på produktet med digitale elementer kan, såfremt arten af produktet med digitale elementer nødvendiggør det, være lavere end 5 mm, forudsat at den fortsat er synlig og læselig.
Artikel 30 3.
CE-mærkningen anbringes, før produktet med digitale elementer bringes i omsætning. Den kan følges af et piktogram eller en anden form for angivelse vedrørende cybersikkerhedsrisiko- eller brugskategori, der er fastsat i de i stk. 6 omhandlede gennemførelsesretsakter.
Artikel 30 4.
Efter CE-mærkningen anføres identifikationsnummeret på det bemyndigede organ, hvis dette organ deltager i den i stk. 6 omhandlede overensstemmelsesvurderingsprocedure på grundlag af fuld kvalitetssikring (baseret på modul H).

Det bemyndigede organs identifikationsnummer anbringes af organet selv eller efter dettes anvisninger af fabrikanten eller dennes bemyndigede repræsentant.
Artikel 30 5.
Medlemsstaterne benytter eksisterende mekanismer til at sikre, at CE-mærkningsordningen anvendes korrekt, og tager passende skridt i tilfælde af uretmæssig anvendelse af mærkningen. Hvis produktet med digitale elementer er omfattet af anden EU-harmoniseringslovgivning end denne forordning, som også indeholder bestemmelser om anbringelse af CE-mærkning, skal CE-mærkningen angive, at produktet ligeledes opfylder kravene i en anden sådan EU-harmoniseringslovgivning.
Artikel 30 6.
Kommissionen kan ved hjælp af gennemførelsesretsakter fastsætte tekniske specifikationer for etiketter, piktogrammer eller andre mærker vedrørende sikkerheden af produkter med digitale elementer, deres supportperioder og mekanismer til at fremme deres anvendelse og til at øge offentlighedens bevidsthed om sikkerheden ved produkter med digitale elementer. Når Kommissionen udarbejder udkastene til gennemførelsesretsakter, hører den relevante interessenter og, hvis denne allerede er blevet nedsat i henhold til artikel 52, stk. 15, ADCO. Disse gennemførelsesretsakter vedtages efter undersøgelsesproceduren, jf. artikel 62, stk. 2.

1.1 Referencer

1.2 Identificerede krav

1.3 Relaterede standarder

2. Identificerede krav

Krav

3. Relaterede standarder

Standarder
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.