CE Marking
The CE marking is a label by which the manufacturer indicates that the radio equipment complies with the applicable requirements set by EU harmonisation legislation, governing its placement on the market. It applies to products manufactured both within and outside the EU, provided they are subsequently placed on the EU market.
What requirements must a product meet to be CE marked?
1. Basic requirements at the EU level for the product
The requirements at the EU level are set out in directives that cover various products or product sectors, such as:
- toys
- electrical devices
- machinery
- medical products
- Radio equipment, etc.
2. Determine Whether the Product Meets Specific Requirements
It is the manufacturer's responsibility to verify whether the product complies with all legal requirements at the EU level. If there are harmonised European standards that the manufacturer follows during the production process, the product will be considered compliant with the requirements set out in the relevant EU directives.
The use of standards is voluntary - you are not obliged to use them. You may choose alternative technical solutions to meet the essential requirements established by the relevant EU directive.
3. Determine Whether the Product Must Be Tested by a Notified Body
Special conformity assessment bodies ("notified bodies") are required to verify the compliance of certain products with specific technical requirements. This is not mandatory for all products. In order to find out which body to contact in a particular case, you can use the "Nando" database.
The definition of the "Nando" database can be found at the following link: The NANDO Information System is a comprehensive database providing information on notified bodies across all EU Member States."
The NANDO Information System is a database containing information about notified bodies in all EU Member States. Through the NANDO Information System, EU Member States inform the European Commission and other member states that a notified body meets the requirements for conducting conformity assessment procedures in a particular area.
4. Test the Product
If the product does not need to be tested by an independent body, the manufacturer is responsible for ensuring that the product complies with technical requirements. This includes assessing and documenting any potential risks associated with the use of the product.
5. Prepare Technical Documentation
The technical documentation must include all documents demonstrating the product’s compliance with technical requirements.
6. Affix the CE Marking and Prepare a Declaration of Conformity
Finally, you can affix the CE mark to the product. The mark must be visible, legible, and indelible. If, in step 3, the involvement of a notified body was required, the identification number of that body must also be affixed to the product. Additionally, a signed EU Declaration of Conformity must be prepared, stating that the product meets all legal requirements.
