+Artigo 18.o Mandatários
---+Artigo 18.o 1.
---+Artigo 18.o 2.
---+Artigo 18.o 3.

Artigo 18.o Mandatários

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1. Visão geral

,
Artigo 18.o 1.
Os fabricantes podem designar um mandatário por meio de um mandato escrito.
Artigo 18.o 2.
Não fazem parte do mandato do mandatário as obrigações previstas no artigo 13.o, n.os 1 a 11, no artigo 13.o, n.o 12, primeiro parágrafo, e no artigo 13.o, n.o 14.
Artigo 18.o 3.

O mandatário pratica os atos especificados no mandato conferido pelo fabricante. O mandatário deve facultar uma cópia do mandato às autoridades de fiscalização do mercado, mediante pedido. O mandato deve permitir ao mandatário praticar, pelo menos, os seguintes atos:

a) 

Manter à disposição das autoridades de fiscalização do mercado a declaração de conformidade UE referida no artigo 28.o e a documentação técnica referida no artigo 31.o durante, pelo menos, 10 anos após a data de colocação do produto com elementos digitais no mercado ou durante o período de apoio, consoante o que for mais longo;

b) 

Mediante pedido fundamentado da autoridade de fiscalização do mercado, facultar-lhe toda a informação e a documentação necessárias para demonstrar a conformidade do produto com elementos digitais;

c) 

Cooperar com as autoridades de fiscalização do mercado, a pedido destas, no que se refere a todas as medidas tomadas para eliminar os riscos decorrentes do produto com elementos digitais abrangido pelo seu mandato.

1.1 Referências

1.2 Requisitos identificados

1.3 Normas relacionadas

2. Requisitos identificados

Requisitos

3. Normas relacionadas

Normas
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.