What is CE marking?
The CE symbol indicates that the product conforms to the essential safety requirements laid down in one or more EU directives applicable to the product itself. It must be affixed to the product before it is placed on the market, except in cases where the specific directives provide otherwise. It should be affixed on the product and/or packaging and/or instructions for use.
The CE marking of the product is mandatory?
The CE marking is mandatory for all products that fall into one of the Community Directives relating to the CE marking in the European Union member countries.
Applicable EC Directives will change depending on the type of product. For each directive is available the list of harmonized standards to which the product should be subject, so it is not possible to affix the CE mark without first carrying out all the tests set out by the legislation.
Who should affix the CE marking?
The CE marking must ALWAYS be affixed by the manufacturer, even if he lives outside the European Union.
What kind of documents the manufacturer or importer must have?
The manufacturer (or the importer, in the case of goods produced outside the EU) must:
draw up a “CE declaration of conformity” which indicates the directive/s applied and standards used;
prepare and keep a “technical construction file” descriptive of the technical characteristics of the product and tests carried out proving the safety of the product itself.
Warning! Declare compliance with harmonized standards means having successfully followed all the tests required by them. This documentation must be available on request of the competent authorities to monitor the market.
What are the necessary steps in order to affix the CE mark on a product?
The steps required to affix the CE mark in the correct way are generally:
Check the applicable EC directives
Check the applicable technical standards
Perform the tests required by the technical standards
Affix the CE mark on product, packaging, user manual
Assemble the technical construction file
Involve, if necessary, the Notified Body
Draw up a declaration of conformity