What is CE marking and what does a conformity assessment entail?

• A. CE marking indicates general branding and does not imply safety compliance.
• B. CE marking indicates compliance with EU safety, health, and environmental requirements; conformity assessment confirms compliance through tests or assessments.
• C. CE marking certifies compliance with U.S. safety standards.
• D. CE marking is only a labeling requirement without assessment.

Answer: (B)

CE marking signals that a product complies with EU safety, health, and environmental requirements set out in the applicable directives. To obtain it, the manufacturer carries out a conformity assessment, which means evaluating the product against the relevant EU standards and directives through testing, risk assessment, and review of technical documentation. In many cases a notified body may perform or witness parts of this assessment, depending on the product category. Once the product meets the requirements, the manufacturer can affix the CE mark, enabling sale throughout the EU.

This isn’t just general branding or a simple label—the mark represents verified compliance through an appropriate assessment process. It’s also specific to EU requirements, not U.S. standards, and it typically involves more than labeling alone, varying by product type and risk.