What It Is

CE Marking (Conformité Européenne) is the EU's primary product conformity framework under the New Legislative Framework (NLF). It signals a manufacturer's declaration that products meet essential health, safety, and environmental requirements in specific harmonised legislation. Scope covers categories like electrical equipment, machinery, and medical devices. Key approach is risk-proportionate, using harmonised standards for presumption of conformity.

Key Components

• Identification of applicable directives/regulations (e.g., LVD 2014/35/EU, Machinery Directive).
• Conformity assessment modules (A-H: self-assessment to full quality assurance).
• Technical documentation, EU Declaration of Conformity (DoC), and CE affixation.
• Post-market surveillance per Regulation (EU) 2019/1020. Self-declaration or Notified Body certification model.

Why Organizations Use It

Mandated for EEA market access; avoids fines, withdrawals. Reduces trade barriers, builds trust, enables single-market scale. Manages liability risks; leverages standards for efficient compliance.

Implementation Overview

Map legislation, conduct risk assessment, compile technical file, issue DoC, affix mark. Applies to manufacturers/importers in EU/EEA; varies by product risk. No central certification; audits via market surveillance. Typical for mid-large firms in manufacturing sectors.

What It Is

PDPA (Personal Data Protection Act 2012) is Singapore's principal regulation governing collection, use, disclosure, and protection of personal data by organizations. It balances individual privacy rights with legitimate business needs through a principles-based approach, including consent, notification, and accountability obligations, with scope covering private sector entities handling identifiable data.

Key Components

• Nine core **obligationsConsent, Notification, Access & Correction, Accuracy, Protection, Retention Limitation, Transfer Limitation, Accountability, and Breach Reporting (Part 6A).
• Built on reasonable purposes and proportionality; mandates Data Protection Officer (DPO).
• Compliance via self-assessment, PDPC guidance; no formal certification but enforceable with fines up to SGD 1 million.

Why Organizations Use It

• Legal requirement for Singapore operations; mitigates fines, enforcement.
• Enhances trust, supports digital economy; enables secure data flows.
• Risk management for breaches; competitive edge via privacy-by-design.

Implementation Overview

• Phased: governance, data mapping, policies, controls, training, audits.
• Applies to all sizes handling personal data in Singapore; extraterritorial elements.
• No certification; PDPC audits, self-DPMP (Data Protection Management Programme).