CE Technical File
The CE technical file is the file that contains all the documents required for certification and required by the manufacturers during the process of obtaining CE Certificate. With this file, the product complies with the relevant CE regulation; It is understood that it has successfully passed the necessary tests, its performance has been verified, and it fulfills its design and functional purpose. The CE technical file contains information such as design and production information of the product, test reports, calculations, standards and regulations used, etc. This file may be required in certain legal processes related to CE Certificate, certification audits, upon the request of the notified body or market surveillance institutions. Manufacturers should keep the CE technical file in order to present it when requested after preparing it during the certification process.
What is CE Technical File? Purpose of CE Technical File
Nowadays, CE Certificate is requested for almost all products. Manufacturers in health, entertainment, electronics, construction and many more sectors must obtain CE Certificate. With this document, it both fulfills the safety requirements related to the product and ensures that the product circulates freely in the market. One of the most critical issues for obtaining the certificate is the CE technical file. This file is a required document in all CE certification processes and every manufacturer applying for a certificate has to prepare this file.
CE technical file is a file in which all the requirements related to certification are documented in terms of its content. In other words, a manufacturer should include the documents used in the steps such as designing and producing the product, explaining how to use this product to the user, performing the safety tests of the product and reporting, etc., the standards, quality criteria, etc. The EC Declaration of Conformity prepared for each product for which CE Certificate will be obtained should also be included in the file. This declaration is a declaration made by the manufacturer, either on its own or through a notified body, to demonstrate that its products comply with CE requirements and is a very important part of the certification process. All CE directives require this declaration to be included in the CE technical file.
How to Prepare CE Technical File? CE Technical File Requirements
If the technical file is prepared smoothly and in accordance with the rules, the CE certification process is completed to a large extent. Because this file is a live document that is actively used the beginning to the end of the documentation. Documents of all the step-by-step operations are placed in the file. Documents related to the design, production, calculation and test processes of the product, instructions for use, certification audits, quality assurance system, etc. should be placed in the CE technical file.
The content of the technical file;
the product itself
referenced regulations and standards
standards used
risk group, category, class and intended use of the product
It may vary depending on how complex the design is, etc. In other words, it is not possible to include exactly the same documents and information in every technical file. However, we can say that many titles are common in technical files in terms of preparation and use.
The general documents that should be included in a CE technical file are:
General description of the product, intended use, brand and model
General information of the manufacturer
Information about the design of the product (works such as technical drawing, calculation, analysis, etc.)
Tests and results to verify product safety
User manual of the product; if it is a multi-component product that requires installation, the assembly manual
Reports of risk analyzes to be made if it falls into a certain risk group
List of standards used, resources utilized and regulations in force for the product at all stages of the certification process
Quality documents related to the product itself, production processes, machinery and equipment used in production and testing (calibration documents, maintenance plans, etc.)
Instructions, safety verifications and quality certificates for the management of areas where the product is produced, packaged, stored and shipped
Who Prepares the CE Technical File?
It is always the manufacturer´s responsibility to prepare a CE technical file. Every manufacturer who plans to obtain CE Certificate for its products has to prepare a technical file and submit it to the certification body in accordance with the relevant regulation. Depending on the product, it can do this by itself or with a notified body (In some cases, the notified body is not needed). For this reason, manufacturers prepare CE technical files.
