CE Marking
EU marking for product conformity to harmonised legislation
EU AI Act
EU regulation for risk-based AI governance
Quick Verdict
CE Marking enables free EU product movement via manufacturer conformity declaration, while EU AI Act mandates risk-based AI controls with CE for high-risk systems. Companies adopt both for legal market access, safety assurance, and regulatory compliance.
CE Marking
CE Marking (Conformité Européenne)
Key Features
- Manufacturer's self-declaration of conformity to EU essential requirements
- Enables free movement across EEA single market
- Presumption of conformity via OJEU-published harmonised standards
- Risk-proportionate conformity assessment modules A-H
- Mandatory technical file retention for 10 years
EU AI Act
Regulation (EU) 2024/1689 Artificial Intelligence Act
Key Features
- Risk-based classification into four tiers
- Prohibitions on unacceptable AI practices
- High-risk conformity assessment and CE marking
- GPAI systemic risk evaluations and reporting
- Tiered fines up to 7% global turnover
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
CE Marking Details
What It Is
CE Marking (Conformité Européenne) is the EU's mandatory conformity marking for products under harmonised legislation like the New Legislative Framework (NLF). It signifies the manufacturer's declaration that products meet essential health, safety, and environmental requirements, enabling free EEA market circulation. The approach is risk-based, using modules A-H for assessment.
Key Components
- Essential requirements from directives (e.g., LVD 2014/35/EU, Machinery Directive).
- Harmonised standards published in OJEU for presumption of conformity.
- Technical documentation, EU Declaration of Conformity (DoC), and CE affixation.
- Self-assessment or Notified Body involvement based on risk.
Why Organizations Use It
Mandated for market access, it ensures legal compliance, reduces trade barriers, manages liability risks, and builds stakeholder trust. Provides competitive edge via streamlined single-market entry and enforcement readiness under Regulation (EU) 2019/1020.
Implementation Overview
Involves legislation mapping, risk assessment, testing, technical file compilation, DoC issuance, and post-market surveillance. Applies to manufacturers/importers of covered products (e.g., electronics, machinery) across EEA. No central certification; self-declared with optional audits.
EU AI Act Details
What It Is
Regulation (EU) 2024/1689, the EU AI Act, is a comprehensive horizontal regulation establishing harmonized rules for AI systems. Its primary purpose is to ensure safety, transparency, and fundamental rights protection across sectors via a **risk-based approachprohibiting unacceptable risks, regulating high-risk systems, transparency for limited-risk, and minimal rules for others.
Key Components
- Four risk tiers with obligations like risk management (Art. 9), data governance (Art. 10), documentation (Arts. 11-13), human oversight (Art. 14), cybersecurity (Art. 15).
- High-risk conformity assessment, CE marking, EU database registration.
- GPAI models (Chapter V) with systemic risk duties.
- Built on product-safety principles; presumption of conformity via harmonized standards.
Why Organizations Use It
- Mandatory for EU-market AI; avoids fines up to 7% global turnover.
- Enhances trust, market access, risk mitigation in high-impact sectors like employment, healthcare.
- Builds competitive edge through auditable governance.
Implementation Overview
- Phased: prohibitions (6 months), GPAI (12 months), high-risk (24-36 months).
- Inventory, classify AI, build QMS, conformity processes.
- Applies to providers/deployers globally if EU outputs; cross-functional for all sizes.
Key Differences
| Aspect | CE Marking | EU AI Act |
|---|---|---|
| Scope | Products under harmonised EU legislation for health/safety | AI systems by risk tiers: prohibited, high-risk, limited, minimal |
| Industry | Manufacturing, electronics, machinery across sectors | AI in employment, biometrics, infrastructure, law enforcement |
| Nature | Manufacturer self-declaration with notified body options | Mandatory regulation with conformity assessment and CE marking |
| Testing | Conformity modules A-H, harmonised standards, self/third-party | Risk management, data governance, cybersecurity testing |
| Penalties | Market withdrawal, fines via national enforcement | Fines up to 7% global turnover for prohibited practices |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about CE Marking and EU AI Act
CE Marking FAQ
EU AI Act FAQ
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