+Artykuł 30 Reguły i warunki dotyczące umieszczania oznakowania CE
---+Artykuł 30 1.
---+Artykuł 30 2.
---+Artykuł 30 3.
---+Artykuł 30 4.
---+Artykuł 30 5.
---+Artykuł 30 6.
|
Artykuł 30 Reguły i warunki dotyczące umieszczania oznakowania CE
-
1. Przegląd
| Tytuł |
Regulacja |
|
Artykuł 30 1.
|
Oznakowanie CE umieszcza się na produkcie z elementami cyfrowymi w sposób widoczny, czytelny i trwały. W przypadku gdy jest to niemożliwe lub nieuzasadnione ze względu na charakter produktu z elementami cyfrowymi, oznakowanie CE umieszcza się na opakowaniu i deklaracji zgodności UE, o której mowa w art. 28, dołączonej do produktu z elementami cyfrowymi. W przypadku produktów z elementami cyfrowymi w formie oprogramowania oznakowanie CE umieszcza się na deklaracji zgodności UE, o której mowa w art. 28, albo na stronie internetowej poświęconej oprogramowaniu. W drugim z tych przypadków odpowiednia sekcja strony internetowej jest łatwo i bezpośrednio dostępna dla konsumentów.
|
|
Artykuł 30 2.
|
Ze względu na charakter produktu z elementami cyfrowymi wysokość oznakowania CE umieszczonego na produkcie z elementami cyfrowymi może być mniejsza niż 5 mm, pod warunkiem że pozostaje ono widoczne i czytelne.
|
|
Artykuł 30 3.
|
Oznakowanie CE umieszcza się przed wprowadzeniem produktu z elementami cyfrowymi do obrotu. Po oznakowaniu CE można umieścić piktogram lub innego rodzaju oznakowanie wskazujące na szczególne ryzyko w cyberprzestrzeni lub zastosowanie określone w aktach wykonawczych, o których mowa w ust. 6.
|
|
Artykuł 30 4.
|
Po oznakowaniu CE podaje się numer identyfikacyjny jednostki notyfikowanej, jeżeli jednostka ta jest zaangażowana w procedurę oceny zgodności opartą na pełnym zapewnieniu jakości (zgodnie z modułem H), o której mowa w art. 32. Numer identyfikacyjny jednostki notyfikowanej umieszcza sama jednostka lub producent albo jego upoważniony przedstawiciel według wskazówek jednostki notyfikowanej.
|
|
Artykuł 30 5.
|
Państwa członkowskie korzystają z istniejących mechanizmów, aby zapewnić prawidłowe stosowanie systemu oznakowania CE, oraz podejmują odpowiednie działania w przypadku jego niewłaściwego wykorzystania. W przypadku gdy produkt z elementami cyfrowymi podlega unijnemu prawodawstwu harmonizacyjnemu innemu niż niniejsze rozporządzenie, w którym również przewiduje się umieszczenie oznakowania CE, oznakowanie to wskazuje, że produkt spełnia również wymogi określone w takim innym unijnym prawie harmonizacyjnym.
|
|
Artykuł 30 6.
|
Komisja może – w drodze aktów wykonawczych – ustanowić specyfikacje techniczne etykiet, piktogramów lub wszelkich innych oznakowań związanych z bezpieczeństwem produktów z elementami cyfrowymi, okresy wsparcia oraz mechanizmy zachęcające do ich stosowania oraz zwiększające świadomość społeczną na temat bezpieczeństwa produktów z elementami cyfrowymi. Przygotowując projekty aktów wykonawczych, Komisja konsultuje się z odpowiednimi zainteresowanymi stronami oraz z grupą ADCO, jeżeli już ją ustanowiono zgodnie z art. 52 ust. 15. Te akty wykonawcze przyjmuje się zgodnie z procedurą sprawdzającą, o której mowa w art. 62 ust. 2.
|
,
1.1 Odwołania
1.2 Zidentyfikowane wymagania
1.3 Powiązane normy
2. Zidentyfikowane wymagania
Wymagania
| Źródło |
Wymaganie |
3. Powiązane normy
Normy
| Źródło |
Wymaganie |
|
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.
|
|