GDPR
EU regulation for personal data protection and privacy
CE Marking
EU marking for product conformity to safety requirements
Quick Verdict
GDPR mandates data privacy for all handling EU personal data globally, while CE Marking requires product safety self-declaration for EEA market access. Companies adopt GDPR to avoid massive fines and build trust; CE Marking to legally sell hardware products.
GDPR
Regulation (EU) 2016/679 - General Data Protection Regulation
Key Features
- Extraterritorial scope applies to non-EU entities targeting EU residents
- Fines up to 4% of global annual turnover for violations
- Accountability principle requires demonstrable compliance via DPIAs and ROPAs
- Enhanced data subject rights including erasure and portability
- Mandatory 72-hour personal data breach notification
CE Marking
CE Marking (Conformité Européenne)
Key Features
- Manufacturer's self-declaration of EU conformity
- Harmonised standards for presumption of conformity
- Risk-based conformity assessment modules A-H
- Technical file retention for 10+ years
- Notified Body involvement for high-risk products
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
GDPR Details
What It Is
Regulation (EU) 2016/679, known as GDPR, is a directly applicable EU regulation protecting natural persons' personal data. It modernizes privacy for the digital age, replacing the 1995 Directive, with extraterritorial scope applying globally to EU data processing. Employs accountability-based, risk-focused approach with seven core principles: lawfulness, purpose limitation, minimization, accuracy, storage limitation, integrity, and accountability.
Key Components
- Seven core principles (Article 5) governing all processing
- Enhanced **data subject rightsaccess, rectification, erasure, portability, objection
- Obligations like DPIAs, DPO appointment, 72-hour breach notifications
- Enforcement via supervisory authorities with fines up to 4% global turnover
- One-stop-shop for cross-border cases
Why Organizations Use It
Mandatory for EU data processors worldwide; mitigates legal risks, avoids massive fines. Builds trust, enables Digital Single Market compliance, inspires global standards like LGPD. Enhances reputation, supports innovation via privacy-by-design.
Implementation Overview
Risk assessments, ROPA maintenance, staff training, vendor contracts. Applies universally to controllers/processors handling EU data; SMEs face high burdens. No certification but ongoing DPA audits; two-year transition originally, continuous thereafter. (178 words)
CE Marking Details
What It Is
CE marking (Conformité Européenne) is the EU's mandatory conformity marking for products under harmonised legislation. It is a manufacturer's self-declaration that products meet essential health, safety, and environmental requirements. The framework follows a risk-based approach via the New Legislative Framework (NLF), using conformity assessment modules (A-H).
Key Components
- Identification of applicable directives (e.g., LVD, Machinery, RED)
- Essential requirements, harmonised standards (OJEU-published for presumption of conformity)
- Technical documentation, EU Declaration of Conformity (DoC), CE affixing
- Self-assessment or Notified Body involvement; post-market surveillance under Reg. 2019/1020
Why Organizations Use It
Enables free EEA market access, ensures legal compliance, mitigates liability risks, builds stakeholder trust, and supports competitive tendering.
Implementation Overview
Map legislation, conduct risk assessments, compile technical files (10-year retention), issue DoC, affix CE. Applies to manufacturers/importers of covered products; audits via Notified Bodies for high-risk items. Suited for all sizes in electronics, machinery, medical devices.
Key Differences
| Aspect | GDPR | CE Marking |
|---|---|---|
| Scope | Personal data protection and privacy | Product safety and conformity |
| Industry | All sectors processing EU data | Manufacturers of specific products |
| Nature | Mandatory EU regulation | Manufacturer self-declaration |
| Testing | DPIAs and compliance audits | Conformity assessment modules |
| Penalties | Up to 4% global turnover fines | Market withdrawal and fines |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about GDPR and CE Marking
GDPR FAQ
CE Marking FAQ
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