When is CE marking required for products sold in the EU?

Last updated: 2026-08-02·Verified: 2026-08-02

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📋 Direct Answer

CE marking is mandatory for products covered by EU harmonization legislation: electrical/electronic equipment, machinery, toys, medical devices, personal protective equipment, construction products, pressure equipment, and more. If your product falls within any EU directive or regulation requiring CE, you must affix the CE mark before selling in the EU. You can self-declare (for low-risk products) or use a Notified Body (for high-risk products). Cost: self-declaration is free; Notified Body testing: €1,000-10,000+.

2
Requirements
Free to €10,000+
Est. Total Cost
1-6 months
Timeline

Item by Item

If applicableSelf-Declaration (Low Risk)
Free (internal testing)1-4 weeks
  1. 1Identify applicable EU directive(s)
  2. 2Conduct conformity assessment using harmonized standards
  3. 3Prepare EU Declaration of Conformity
  4. 4Affix CE mark to product and packaging
If applicableNotified Body (High Risk)
€1,000-10,000+2-6 months
  1. 1Contact an EU Notified Body for product assessment
  2. 2Submit technical documentation for review
  3. 3Receive EU type-examination certificate
  4. 4Affix CE mark based on certificate

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Sources

  • European Commission CE marking guidance
  • NANDO database (Notified Bodies)

Disclaimer: This page is for informational purposes only and does not constitute legal or tax advice. Consult a professional for your specific situation.