The CE Certificate is a safety sign used to make the regulation on technical structures simpler and more general in order to ensure the full free movement of products within the framework of compliance with the European Union technical legislation.
The CE Mark is a sign of conformity with the European Union New Approach Directives, indicating that the product on which it is attached is safe for the environment in which it is used. A product may enter more than one New Approach Directive, and the CE Marking affixed to the product fulfilling the necessary requirements indicates that the product complies with all of these directives. Compliance with the directives means meeting the essential requirements of the directives by following the relevant conformity assessment procedures specified in the directives. These basic requirements stipulate the requirements for product safety.
However, the basic requirements do not directly specify the requirements for the performance characteristics and quality of the product. Therefore, the CE Mark is intended for the safety of products and is primarily intended for free movement within the European Union.
The manufacturer decides the marking requirements of the product according to the scope of the directive and the risk situation and is obliged to take the necessary steps. The product whose risk is determined is subject to conformity assessment by the notified body. Then, the marking and certification process of the product is decided.
The certification process is generally as follows.
Definition of the applicable Directive;
The first step is to determine whether the product has the ce mark requirement. Products falling into at least one of the sectorally published directives must bear the CE Mark. A product may also enter more than one directive if it is not covered by the directive, the product does not have to bear the CE mark.
Identify the requirements of the Directive:
The assessment of each directive according to the area of use and risk factor of the product may be different. Each directive has a number to meet before the product is placed on the market.
Conformity Assessment
Determination of the product's requirements for risk assessment and conformity assessment body.
Product evaluation
Establishment of a Factory Production Control System for third party audits
EC type tests for third party inspections
Conformity Assessment of the Product
It should be determined whether the product complies with all the requirements covered by the Directive. For example, product type tests or compliance with the necessary conditions to ensure.
Preparation of Technical Documents;
Technical files should be prepared according to the norms and directives to which the products are subject. This information should include product design, development and product details.
Information required in the technical file;
Technical information about the product
Technical drawings, circuit diagrams and pictures
All component information about the product
Specifications for declaration of conformity
Product test reports
Instructions
EC declaration of conformity
This information must be kept for a period of one year from the last batch of the product.
