One of the most important processes in CE marking is product testing. Within the framework of the New Approach Directives, the manufacturer has been held responsible for the CE marking on most of the products covered by the directives.
It is entirely within the competence of the manufacturer to prepare a European Union declaration of conformity for low-risk products and to affix the CE marking on the products, depending on the risk level of the product.
In order to fulfill these obligations, to comply with the requirements of the relevant legal regulations and to ensure compliance with the harmonized standards, manufacturers must either test the products at their own expense or have them tested by competent institutions or laboratories.
These test results must be included in the technical dossier, which must be prepared during CE marking.
Certain steps must be taken for CE mark approval under the New Approach program Depending on the type of product and the nature of the risks it carries, it is necessary to first determine which directives or directives apply to the product. Sometimes a product may fall under more than one directive. The next step should determine the extent to which the product complies with the requirements for design and production in the specified directive or directives. In the third step, a conformity assessment process should be selected for the product from the options (modules) specified in the directive. The following modules are available for conformity assessment processes:
Module A: Internal production control
Module Aa: Intervention by notified body
Module B: European Union type examination
Module C: Type compliance
Module D: Production quality assurance
Module E: Product quality assurance
Module F: Product verification
Module G: Unit verification
Module H: Full quality assurance
Under the New Approach program, directives use a series of questions about the nature of the product in terms of classifying the risk level and selecting an appropriate conformity assessment procedure.
The options for low-risk products include the certification that the manufacturer has drawn up a declaration of conformity and has attached the CE marking to the product.
High-risk products are products with greater risk for certification and product testing must be performed and approved by a notified body. The notified bodies are those officially nominated and accepted by the European Commission. These organizations act as independent test laboratories and implement the processes in the directives. Notified bodies can be either private or governmental organizations. Manufacturers may select the notified body in any European Union country. The list of notified bodies is published in the Official Journal of the European Communities and in a database called Nando (New Approach Notified and Designated Organizations).
The notified body generally conducts product tests, issues a type-examination certificate, evaluates the technical file and design file, supervises the product and quality system and defines standards.
If products for the CE marking need to be approved by a notified body, the manufacturer determines the appropriate product standards and test methods for the product and selects a notified body. Some directives require the appointment of a representative in the European Union. In this case, the manufacturer must appoint a representative. The next step is to prepare a declaration of conformity. This declaration shall contain the product description, the name and address of the manufacturer and the directives or directives and standards covered by it. The final step is to affix the CE mark on the product.
Our company also provides CE product testing services within the scope of certification services. Thanks to these services, enterprises are able to produce more efficient, high performance and quality products in a safe, fast and uninterrupted manner.
CE product testing services provided within the scope of certification services are only one of the services provided by our organization in this regard. Many other certification services are also available.