+Artikel 30 Regels en voorwaarden voor het aanbrengen van de CE-markering
---+Artikel 30 1.
---+Artikel 30 2.
---+Artikel 30 3.
---+Artikel 30 4.
---+Artikel 30 5.
---+Artikel 30 6.

Artikel 30 Regels en voorwaarden voor het aanbrengen van de CE-markering

-

1. Overzicht

,
Artikel 30 1.
De CE-markering wordt zichtbaar, leesbaar en onuitwisbaar op het product met digitale elementen aangebracht. Wanneer dat gezien de aard van het product met digitale elementen niet mogelijk of gerechtvaardigd is, wordt de markering aangebracht op de verpakking en op de in artikel 28 bedoelde EU-conformiteitsverklaring die het product met digitale elementen vergezelt. Voor producten met digitale elementen in de vorm van software wordt de CE-markering aangebracht hetzij op de in artikel 28 bedoelde EU-conformiteitsverklaring, hetzij op de website die bij het softwareproduct hoort. In het laatste geval is het relevante gedeelte van de website eenvoudig en rechtstreeks toegankelijk voor consumenten.
Artikel 30 2.
Gezien de aard van het product met digitale elementen mag de hoogte van de CE-markering die op het product met digitale elementen wordt aangebracht, minder dan 5 mm bedragen, mits de markering zichtbaar en leesbaar blijft.
Artikel 30 3.
De CE-markering wordt aangebracht voordat het product met digitale elementen in de handel wordt gebracht. Zij kan worden gevolgd door een pictogram of een ander merkteken dat wijst op een bijzonder cyberbeveiligingsrisico of gebruik, zoals bepaald in de in lid 6 bedoelde uitvoeringshandelingen.
Artikel 30 4.
De CE-markering wordt gevolgd door het identificatienummer van de aangemelde instantie, indien die instantie betrokken is bij de in artikel 32 bedoelde conformiteitsbeoordelingsprocedure op basis van volledige kwaliteitsborging (op basis van module H).

Het identificatienummer van de aangemelde instantie wordt aangebracht door die instantie zelf dan wel overeenkomstig haar instructies door de fabrikant of de gemachtigde vertegenwoordiger van de fabrikant.
Artikel 30 5.
De lidstaten bouwen voort op bestaande mechanismen om de correcte toepassing van de regeling inzake de CE-markering te waarborgen en nemen passende maatregelen in geval van oneigenlijk gebruik van die markering. Indien het product met digitale elementen onderworpen is aan andere harmonisatiewetgeving van de Unie dan deze verordening, die ook voorziet in het aanbrengen van de CE-markering, geeft de CE-markering aan dat het product ook aan de vereisten van dergelijke andere harmonisatiewetgeving van de Unie voldoet.
Artikel 30 6.
De Commissie kan door middel van uitvoeringshandelingen technische specificaties vaststellen voor etiketten, pictogrammen of andere merktekens die verband houden met de beveiliging van producten met digitale elementen, de ondersteuningsperioden ervan alsook mechanismen om het gebruik ervan te bevorderen en het publieke bewustzijn omtrent de veiligheid van producten met digitale elementen te vergroten. Bij het opstellen van de ontwerpuitvoeringshandelingen raadpleegt de Commissie de relevante belanghebbenden en, indien die reeds is opgericht op grond van artikel 52, lid 15, de ADCO. Die uitvoeringshandelingen worden volgens de in artikel 62, lid 2, bedoelde onderzoeksprocedure vastgesteld.

1.1 Referenties

1.2 Geïdentificeerde eisen

1.3 Gerelateerde standaarden

2. Geïdentificeerde eisen

Eisen

3. Gerelateerde standaarden

Standaarden
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.