+Artikolu 30 Regoli u kundizzjonijiet għat-twaħħil tal-markatura CE
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Artikolu 30 Regoli u kundizzjonijiet għat-twaħħil tal-markatura CE

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1. Ħarsa ġenerali

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Artikolu 30 1.
Il-markatura CE għandha titwaħħal b’mod viżibbli, leġġibbli u indelibbli mal-prodott b’elementi diġitali. Meta dan ma jkunx possibbli jew ma jkunx ġustifikat minħabba n-natura tal-prodott b’elementi diġitali, din għandha titwaħħal mal-imballaġġ u mad-dikjarazzjoni ta’ konformità tal-UE msemmija fl-Artikolu 28 li takkumpanja l-prodott b’elementi diġitali. Għal prodotti b’elementi diġitali li jkunu fil-forma ta’ software, il-markatura CE għandha titwaħħal jew mad-dikjarazzjoni ta’ konformità tal-UE msemmija fl-Artikolu 28 jew fuq is-sit web li jakkumpanja l-prodott tas-software. Fil-każ tal-aħħar, it-taqsima rilevanti tas-sit web għandha tkun aċċessibbli faċilment u direttament għall-konsumaturi.
Artikolu 30 2.
Minħabba n-natura tal-prodott b’elementi diġitali, l-għoli tal-markatura CE mwaħħla mal-prodott b’elementi diġitali jista’ jkun anqas minn 5 mm, dment li tibqa’ viżibbli u tkun jista’ jinqara.
Artikolu 30 3.
Il-markatura CE għandha titwaħħal qabel ma l-prodott b’elementi diġitali jiġi introdott fis-suq. Din tista’ tiġi segwita minn pittogramma jew kwalunkwe marka oħra li tindika riskju għaċ-ċibersigurtà jew użu speċjali stabbilit fl-atti ta’ implimentazzjoni msemmija fil-paragrafu 6.
Artikolu 30 4.
Il-markatura CE għandha tiġi segwita min-numru ta’ identifikazzjoni tal-korp notifikat, meta dak il-korp ikun involut fil-proċedura ta’ valutazzjoni ta’ konformità bbażata fuq assigurazzjoni sħiħa tal-kwalità (ibbażata fuq il-modulu H) imsemmija fl-Artikolu 32.

In-numru ta’ identifikazzjoni tal-korp notifikat għandu jitwaħħal mill-korp innifsu jew, skont l-istruzzjonijiet tiegħu, mill-manifattur jew mir-rappreżentant awtorizzat tal-manifattur.
Artikolu 30 5.
L-Istati Membri għandhom jibnu fuq il-mekkaniżmi eżistenti biex jiżguraw l-applikazzjoni korretta tar-reġim li jirregola l-markatura CE u għandhom jieħdu l-azzjoni xierqa fil-każ ta’ użu mhux korrett ta’ dik il-markatura. Meta l-prodott b’elementi diġitali jkun soġġett għal leġiżlazzjoni tal-Unjoni dwar l-armonizzazzjoni, għajr dan ir-Regolament, li wkoll tipprevedi t-twaħħil tal-markatura CE, il-markatura CE għandha tindika li l-prodott jissodisfa wkoll ir-rekwiżiti stabbiliti f’tali leġiżlazzjoni oħra tal-Unjoni dwar l-armonizzazzjoni.
Artikolu 30 6.
Il-Kummissjoni tista’, permezz ta’ atti ta’ implimentazzjoni, tistabbilixxi speċifikazzjonijiet tekniċi għal tikketti, pittogrammi jew kwalunkwe marka oħra relatata mas-sigurtà tal-prodotti b’elementi diġitali, il-perjodi ta’ appoġġ tagħhom u l-mekkaniżmi biex jiġi promoss l-użu tagħhom u biex tiżdied is-sensibilizzazzjoni tal-pubbliku dwar is-sigurtà tal-prodotti b’elementi diġitali. Meta tħejji l-abbozzi tal-atti ta’ implimentazzjoni, il-Kummissjoni għandha tikkonsulta mal-partijiet ikkonċernati rilevanti, u, jekk ikun diġà ġie stabbilit skont l-Artikolu 52(15), mal-ADCO. Dawk l-atti ta’ implimentazzjoni għandhom jiġu adottati f’konformità mal-proċedura ta’ eżami msemmija fl-Artikolu 62(2).

1.1 Referenzi

1.2 Rekwiżiti identifikati

1.3 Standards relatati

2. Rekwiżiti identifikati

Rekwiżiti

3. Standards relatati

Standards
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.