+Articolo 18 Rappresentanti autorizzati
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Articolo 18 Rappresentanti autorizzati

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1. Panoramica

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Articolo 18 1.
Un fabbricante può nominare, mediante mandato scritto, un rappresentante autorizzato.
Articolo 18 2.
Gli obblighi di cui all’articolo 13, paragrafi da 1 a 11, paragrafo 12, primo comma, e paragrafo 14, non rientrano nel mandato del rappresentante autorizzato.
Articolo 18 3.

Il rappresentante autorizzato esegue i compiti specificati nel mandato ricevuto dal fabbricante. Il rappresentante autorizzato fornisce una copia del mandato alle autorità di vigilanza del mercato su richiesta. Tale mandato consente al rappresentante autorizzato di svolgere almeno i seguenti compiti:

a) 

mantenere a disposizione delle autorità di vigilanza del mercato la dichiarazione di conformità UE di cui all’articolo 28 e la documentazione tecnica di cui all’articolo 31 per un periodo di almeno dieci anni dalla data in cui il prodotto con elementi digitali è stato immesso sul mercato o per la durata del periodo di assistenza, se quest’ultimo è superiore;

b) 

a seguito di una richiesta motivata di un’autorità di vigilanza del mercato, fornire a tale autorità tutte le informazioni e la documentazione necessarie a dimostrare la conformità del prodotto con elementi digitali;

c) 

collaborare con le autorità di vigilanza del mercato, su richiesta di queste ultime, a qualsiasi azione intrapresa per eliminare i rischi posti da un prodotto con elementi digitali che rientra nel suo mandato.

1.1 Riferimenti

1.2 Requisiti identificati

1.3 Standard correlati

2. Requisiti identificati

Requisiti

3. Standard correlati

Standard
SCF Designated Certifying Official

Description

Mechanisms exist to designate an individual with the authority to make statements of conformity on behalf of the organization.

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

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 designate an individual the authority to make statements of conformity on behalf of the organization.

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.