Ultimate Guidance Of Technical Files For Product Ce Marking

By Author: John
Total Articles: 251
Comment this article

The CE marking, which stands for "Conformite Europeenne" in French, attests to a product's compliance with EU requirements for consumer safety, environmental protection, and health. To market their products in Europe, manufacturers both within and outside of the European Union (EU) must adhere to the necessary CE certification criteria. Many directives and rules governing CE marking omit to mention the specific products that are under their purview. Instead, this lists the broad range of the product (such as input and output voltage). Because of this, figuring out whether a specific directive or regulation applies to a manufacturer's or importer's goods can be complicated. Additionally, if a product is not covered by any EU legislation that mandates the CE mark, it is not permitted to print the CE mark on it.
Before submitting the final Declaration of Conformity, manufacturers of non-food products are required by all European CE-marking directives and regulations to create technical documents, often known as a "Technical File." The technical files must show beyond a reasonable doubt that a product complies with all applicable ...
... product safety regulations.
The technical file is a collection of documentation demonstrating that a product is compliant with CE marking regulations. The CE Marking documents must describe the product's design, manufacturing, and use as well as the appropriate product safety regulations. Regardless of the product's location of origin, the national market surveillance authorities must have access to the technical file as soon as it is placed on the European single market. In some cases, a Notified Body may also need to review the documentation. The technical file must typically be kept by the maker or their authorized representative for at least 10 years following the final day the product was manufactured. However, various CE-marking regulations offer an alternative time frame.
What format does the technical file have?
The organization and format of technical files are not subject to any legal obligations. There are both electronic and physical versions of the documentation available. The technical file, however, needs to remain up-to-date continuously. As a result, producers are required to update the file's information whenever the product is modified or when pertinent directives or rules are altered.
Which languages must be used in the technical file?
The technical file for CE Marking must be developed in the language that the Notified Body accepts or in the official language of the Member State where the conformance processes will be carried out. Technical documentation written in English is typically accepted by all certification authorities.
What does the technical documentation contain?
Each CE-marking directive has a particular set of technical documentation requirements. The documentation should, however, generally have at least these components:
• A general summary of the product
• Conceptual product designs for manufacturing, as well as, if necessary, component, circuit, and other scheme diagrams
• Descriptions and justifications required to comprehend those diagrams and plans
• A list of the standards that were fully or partially used in the conformity assessment process, including those that were harmonized and those that were not
• Test results and a risk analysis file
• Copies of the compliance assessment reports for important product components
• Guidelines for use
• a copy of the Declaration of Compliance
The precise information included in the technical file varies depending on the nature of the product and what is deemed necessary for establishing the product's adherence to the essential product safety requirements of the applicable directive(s).
Source: https://cemarkprocedures.wordpress.com/2023/06/22/ultimate-guidance-of-technical-files-for-product-ce-marking/