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
- Confirm product, use, market and economic operators
- Build the legislation and harmonised-standard matrix
- Complete testing, risk assessment and any mandatory third-party assessment
- Compile technical documentation and EU DoC before marking
- 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.