Producer companies issued by the European Union New Approach Directives products must be CE marked. Therefore, for a product produced within this scope, manufacturers who want to put CE mark on their product or products must first prepare a technical file for this product.
The technical dossier forms the basis of CE labeling studies. Producer companies will prepare this technical file whether or not their products fall into risky class. Also prepared technical file CE labeling by the manufacturing companies who wish to exercise their rights during production activities and unless there is a functional change in the product.
The technical dossier should contain product design studies, production processes and operational information. This information must be prepared to demonstrate that the product complies with the essential requirements of the directives.
For example, the information and documents required in a technical file are:
- Basic information about the manufacturer
- A label with product technical information
- Use the product for what purpose
- Test reports
- List of national and international standards used in production
- Supply list
- If the supply products are under CE certificates and test reports
- Declaration of Conformity to the European Union
- Product installation, adjustment, operation, maintenance and transport activities
- If there are components of the product, their manufacturers, code numbers, technical specifications and test reports, if any
- Product instruction manual
The period of retention of the technical dossier is ten years at the most, unless otherwise agreed. The technical dossier shall constitute a reference for any application to be made regarding the CE criteria from outside the manufacturer. If CE labeling is authorized certification body The manufacturer must obtain and keep a copy of this file. In this case, the original file will be in the relevant certification body.
The manufacturer can carry out CE marking in two ways:
- If the product does not fall into the risky class, it is authorized to place the CE label. You can get a counseling service if you want about it.
- If the product falls into a risky class, the product must be tested by an authorized testing and inspection body or laboratory.
The manufacturer is also able to put the CE label on the product. European Union Declaration of Conformity prepare and put into the technical file. This declaration of conformity is part of the conformity assessment processes described in the New Approach Directives. All applied directives, manufacturers, authorized representatives of the manufacturers, the waste made to the standards and other documents that have been complied with must be included in the Declaration of Conformity to the European Union.
The TÜRCERT certification organization not only carries out certification activities, but also provides technical services such as various inspection and testing activities. Therefore, if you want to get more information about the CE marking and how to put the CE marking, the experienced managers and employees of the TÜRCERT certification body will always be with you.