+Article 11 General product safety

Article 11 General product safety

Article 11

General product safety

By way of derogation from Article 2(1), third subparagraph, point (b), of Regulation (EU) 2023/988, Chapter III, Section 1, Chapters V and VII, and Chapters IX to XI of that Regulation shall apply to products with digital elements with respect to aspects and risks or categories of risks that are not covered by this Regulation where those products are not subject to specific safety requirements laid down in other ‘Union harmonisation legislation’ as defined in Article 3, point (27), of Regulation (EU) 2023/988.

1. Übersicht

Bezeichnung Regulierung

1.1 Referenzen

1.2 Identifizierte Anforderungen

1.3 Related Standards

2. Identifizierte Anforderungen

Anforderungen
Source Anforderung

3. Related Standards

Standards
Source Anforderung
SCF Serious Incident Reporting

Description

Mechanisms exist to report any serious incident involving the organization's Technology Assets, Applications, Services and/or Data (TAASD) to relevant authorities in the locality where the incident occurred, in accordance with mandatory reporting:
(1) Requirements; and
(2) Timelines.

Possible Solutions & Considerations

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

∙ Basic incident response plan
∙ Designate incident response contact

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

∙ Documented incident response plan
∙ Incident log
∙ Designated IR team

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

∙ Formal incident response program
∙ IR playbooks
∙ Tabletop exercises

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

∙ Enterprise incident response program
∙ 24/7 SOC monitoring
∙ SOAR platform

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

∙ Enterprise SOC with SIEM/SOAR (e.g., Splunk SOAR, Palo Alto XSOAR)
∙ IR retainer
∙ Threat hunting

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

Incident Response (IRO) 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 IRO domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with DCH 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 IRO domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Incident response-related controls are primarily administrative and preventative in nature (e.g., policies, standards, procedures & guidelines).
▪ Incident response management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ IT and/or cybersecurity personnel operate an incident response capability using a documented and tested Incident Response Plan (IRP) to facilitate incident management operations that cover preparation, detection and analysis, containment, eradication and recovery.

Level 3 Well Defined

Incident Response (IRO) 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 IRO domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Cybersecurity personnel operate an incident response capability using a documented and tested Incident Response Plan (IRP) to facilitate incident management operations that cover preparation, detection and analysis, containment, eradication and recovery.
▪ An incident response team, or similar function, is appropriately staffed and supported to implement and maintain IRO domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of incident response operations (e.g., incident management software, etc.).
▪ 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 IRO 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 report any serious incident involving the organization's TAASD to relevant authorities in the locality where the incident occurred, in accordance with mandatory reporting:
(1) Requirements; and
(2) Timelines.

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.
SCF Disclosure of Vulnerabilities

Description

Mechanisms exist to disclose information about vulnerabilities to relevant stakeholders, including:
(1) A description of the vulnerability(ies);
(2) Affected product(s) and/or service(s);
(3) Potential impact of the vulnerability(ies);
(4) Severity of the vulnerability(ies); and
(5) Guidance to remediate the vulnerability(ies).

Possible Solutions & Considerations

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

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

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

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

∙ Red team exercises for critical applications

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

∙ Enterprise red team program
∙ Regular adversarial simulation exercises

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, 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, NIST SP 800-160, etc.).
▪ 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, software testing tools, etc.).
▪ 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 disclose information about vulnerabilities to relevant stakeholders, including:
(1) A description of the vulnerability(ies);
(2) Affected product(s) and/or service(s);
(3) Potential impact of the vulnerability(ies);
(4) Severity of the vulnerability(ies); and
(5) Guidance to remediate the vulnerability(ies).

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.
SCF Reporting Exploitable Vulnerabilities

Description

Mechanisms exist to notify applicable stakeholders about potentially exploitable vulnerabilities in organization-developed Technology Assets, Applications and/or Services (TAAS), as required by statutory, regulatory and/or contractual obligations.

Possible Solutions & Considerations

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

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

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

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

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

∙ Enterprise formal verification for highest-assurance systems

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, 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, NIST SP 800-160, etc.).
▪ 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, software testing tools, etc.).
▪ 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 notify applicable stakeholders about potentially exploitable vulnerabilities in organization-developed Technology Assets, Applications and/or Services (TAAS), as required by statutory, regulatory and/or contractual obligations.

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.
SCF Software Bill of Materials (SBOM)

Description

Mechanisms exist to generate, or obtain, a Software Bill of Materials (SBOM) for Technology Assets, Applications and/or Services (TAAS) that lists software packages in use, including versions and applicable licenses.

Possible Solutions & Considerations

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

∙ Software Bill of Materials (SBOM)
∙ Cybersecurity Supply Chain Risk Management (C-SCRM) program
∙ Product / project management

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

∙ Software Bill of Materials (SBOM)
∙ Cybersecurity Supply Chain Risk Management (C-SCRM) program
∙ Product / project management

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

∙ Software Bill of Materials (SBOM)
∙ Cybersecurity Supply Chain Risk Management (C-SCRM) program
∙ Product / project management

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

∙ Software Bill of Materials (SBOM)
∙ Cybersecurity Supply Chain Risk Management (C-SCRM) program
∙ Product / project management

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

∙ Software Bill of Materials (SBOM)
∙ Cybersecurity Supply Chain Risk Management (C-SCRM) program
∙ Product / project 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

SCR-CMM Level 2 criteria definitions are not available for this control:
▪ A reasonable person would conclude a well-defined and standardized process is required.
▪ At this level of maturity, the “requirements-driven” nature of performing the control is focused on a localized and/or regionalized implementation, not uniform and consistent across the organization.
▪ Requirements are narrowly scoped for applicability and are primarily derived from compliance obligations (e.g., laws, regulations and contracts).

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, software testing tools, etc.).
▪ 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 generate, or obtain, a Software Bill of Materials (SBOM) for Technology Assets, Applications and/or Services (TAAS) that lists software packages in use, including versions and applicable licenses.

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.
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