CE marking is mandatory for a wide range of products sold in the European Union. Products that must be CE marked, but are not, cannot be sold in the EU.
Regulations and directives
CE marking is mandatory for products that fall within several EU regulations and directives. Here are some examples:
- Toy Safety Directive
- Low Voltage Directive
- EMC Directive
- RoHS Directive
- Ecodesign Directive
- Radio Equipment Directive
- Machinery Regulation
- Medical Devices Regulation
- Personal Protective Equipment Regulation
Product examples
- Toys
- Electronics
- Machinery
- Medical devices
- Personal protective equipment
Requirements
CE marking can only be affixed after a product has undergone a conformity assessment procedure. The exact requirements differ depending on the product type – but can often include the following:
1. Conformity with harmonised standards
2. Traceability labelling
3. Declaration of Conformity
4. User instructions
5. Technical documentation
Notified bodies are also required in some cases.
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