EU regulationen
CE marking
A mandatory marking certifying that a product complies with the essential requirements of EU safety, health and environmental directives.
CE marking (Conformité Européenne) is a mandatory regulatory marking affixed to a product to indicate it meets the essential requirements of applicable European directives and regulations on safety, health, environmental protection and consumer protection.
CE marking applies to numerous product categories:
- Machinery and equipment
- Medical devices
- Toys
- Low voltage electrical equipment
- Personal protective equipment
- Construction products
- Pressure equipment
The conformity assessment procedure comprises:
- Identification of applicable directives/regulations
- Verification of conformity with harmonised standards (EN)
- Conformity assessment: self-declaration or notified body involvement depending on risk category
- Compilation of the technical file
- EU Declaration of Conformity and affixing of the CE marking
The manufacturer (or importer if the manufacturer is outside the EU) is responsible for conformity. The importer must verify that the manufacturer has followed the correct procedure and retain the technical file for 10 years.