+Artikel 20 Pflichten der Händler
---+Article 20 1.
---+Article 20 2.
---+Article 20 3.
---+Article 20 4.
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Artikel 20 Pflichten der Händler
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1. Übersicht
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Regulierung |
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Article 20 1.
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When making a product with digital elements available on the market, distributors shall act with due care in relation to the requirements set out in this Regulation.
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Article 20 2.
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Before making a product with digital elements available on the market, distributors shall verify that:
(a)
the product with digital elements bears the CE marking;
(b)
the manufacturer and the importer have complied with the obligations set out in Article 13(15), (16), (18), (19) and (20) and Article 19(4), and have provided all necessary documents to the distributor.
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Article 20 3.
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Where a distributor considers or has reason to believe, on the basis of information in its possession, that a product with digital elements or the processes put in place by the manufacturer are not in conformity with the essential cybersecurity requirements set out in Annex I, the distributor shall not make the product with digital elements available on the market until that product or the processes put in place by the manufacturer have been brought into conformity with this Regulation. Furthermore, where the product with digital elements poses a significant cybersecurity risk, the distributor shall inform, without undue delay, the manufacturer and the market surveillance authorities to that effect.
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Article 20 4.
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Distributors who know or have reason to believe, on the basis of information in their possession, that a product with digital elements, which they have made available on the market, or the processes put in place by its manufacturer are not in conformity with this Regulation shall make sure that the corrective measures necessary to bring that product with digital elements or the processes put in place by its manufacturer into conformity, or to withdraw or recall the product, if appropriate, are taken. Upon becoming aware of a vulnerability in the product with digital elements, distributors shall inform the manufacturer without undue delay about that vulnerability. Furthermore, where the product with digital elements presents a significant cybersecurity risk, distributors shall immediately inform the market surveillance authorities of the Member States in which they have made the product with digital elements available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.
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Article 20 5.
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Distributors shall, further to a reasoned request from a market surveillance authority, provide all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the product with digital elements and the processes put in place by its manufacturer with this Regulation in a language that can be easily understood by that authority. They shall cooperate with that authority, at its request, on any measures taken to eliminate the cybersecurity risks posed by a product with digital elements which they have made available on the market.
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Article 20 6.
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Where the distributor of a product with digital elements becomes aware, on the basis of information in its possession, that the manufacturer of that product has ceased its operations and, as result, is not able to comply with the obligations laid down in this Regulation, the distributor shall inform, without undue delay, the relevant market surveillance authorities about this situation, as well as, by any means available and to the extent possible, the users of the products with digital elements placed on the market.
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1.1 Referenzen
1.2 Identifizierte Anforderungen
1.3 Zugehörige Standards
2. Identifizierte Anforderungen
Anforderungen
| Quelle |
Anforderung |
3. Zugehörige Standards
Standards
| Quelle |
Anforderung |
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SCF
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Declaration of Conformity
Description
Mechanisms exist to generate a declaration of conformity for each conformity assessment, where the document:
(1) Is concise;
(2) Unambiguously reflects the current status;
(3) Is physically or electronically signed; and
(4) Where possible, is machine readable.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Document applicable regulatory requirements in a checklist
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Compliance checklist
∙ Annual compliance review
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Compliance management program
∙ Regulatory mapping
∙ Compliance calendar
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Compliance team
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.)
∙ Dedicated compliance team
∙ Automated compliance monitoring
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
Compliance (CPL) 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 CPL domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with CPL 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 CPL domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Compliance management controls-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Compliance management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ External compliance requirements for cybersecurity and data privacy are identified and documented, based on applicable laws, regulations and contractual obligations.
▪ A formal report is generated for each security assessment/audit with sufficient details to understand the organization's ability to demonstrate conformity with its requirements.
Level 3 Well Defined
Compliance (CPL) 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 CPL 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 CPL domain capabilities are well-documented and kept current by process owners.
▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain CPL domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC platform).
▪ 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 CPL 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 a declaration of conformity for each conformity assessment, where the document:
(1) Is concise;
(2) Unambiguously reflects the current status;
(3) Is physically or electronically signed; and
(4) Where possible, is machine readable.
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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SCF
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Security, Compliance & Resilience Status Reporting
Description
Mechanisms exist to submit status reporting of the organization's security, compliance and/or resilience program to applicable statutory and/or regulatory authorities, as required.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Maintain records for any required compliance filings
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Designate a compliance contact for required reporting
∙ Track reporting deadlines
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Compliance calendar for required submissions
∙ Documented reporting procedures
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ Compliance tracking platform
∙ Dedicated compliance officer
∙ Standardized reporting templates
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise GRC platform for compliance reporting
∙ Dedicated compliance team
∙ Automated regulatory submission tracking
∙ Legal and compliance integration
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
Compliance (CPL) 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 CPL 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 CPL domain capabilities are well-documented and kept current by process owners.
▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain CPL domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC platform).
▪ 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 CPL 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 submit status reporting of the organization's security, compliance and/or resilience program to applicable statutory and/or regulatory authorities, as required.
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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SCF
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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.
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SCF
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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
∙ Notify customers of vulnerabilities in any developed products via email/website
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Security advisory template and distribution process
∙ security.txt / contact for vulnerability reports
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Vulnerability disclosure process with advisories (description, impact, remediation)
∙ Coordinated disclosure timelines
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ Product Security Incident Response Team (PSIRT) disclosure process (ISO/IEC 29147)
∙ CVE issuance for product vulnerabilities
∙ Customer notification channels
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ Enterprise coordinated vulnerability disclosure program (ISO/IEC 29147, CNA participation)
∙ Public advisory portal and machine-readable advisories (CSAF)
∙ Regulatory notification (e.g., EU CRA) integration
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 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.
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 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.
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