Standard & market guideCETTS / Certification

Where it applies

Only products covered by EU legislation requiring CE marking may bear it, such as toys, certain machinery, electrical/electronic equipment, radio equipment, PPE and some medical devices. Products outside such legislation must not use CE marking.

What the evidence needs to show

  • The manufacturer identifies all applicable legislation and essential requirements
  • Harmonised standards can provide presumption of conformity, subject to current Official Journal references and restrictions
  • Risk assessment, test evidence, technical documentation, EU DoC and correct marking are normally required
  • Importers, authorised representatives and distributors have their own duties

Build the evidence in this order

  1. Confirm product, use, market and economic operators
  2. Build the legislation and harmonised-standard matrix
  3. Complete testing, risk assessment and any mandatory third-party assessment
  4. Compile technical documentation and EU DoC before marking
  5. Control model, material, regulatory and complaint changes

Common misunderstandings

  • CE is not a mark of origin and does not mean the EU has approved the product
  • One test report rarely proves compliance with every applicable law
  • Technical documentation and the DoC must remain current and be retained as required

Official reference

Official EU CE-marking guidance ↗

Confirm product-specific scope and the applicable edition with TTS before making a compliance decision.

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