Introduction to the technical dossier
The import of products within the European Union (EU) involves a series of requirements and procedures that manufacturers (important to know clearly the definition of manufacturer) must be met to ensure the safety and quality of their products. In this context, the technical file and the technical documentation play a critical role.
The technical file is a set of documents that provides detailed information on the design, the manufacturing and the operation of a product. It is essential to demonstrate the compliance of the requirements and regulations applicable in the EU market. From product design to marketing, the technical file records every stage of the process, ensuring the traceability and transparency in all stages of production.
On the other hand, the technical documentation includes the documentation needed to support the compliance of the product with the standards and regulations of the EU. This documentation includes a variety of information, such as technical specifications, test results, statements of compliance and more. It is essential to obtain the CE Marking, which indicates that the product complies with the legal requirements for marketing in the EU.
The preparation of the technical file and the technical documentation should be carried out before the introduction of the product in the market. This involves gathering and organizing all the relevant information about the product, from its initial design until the results of the tests of conformity. In addition, it is crucial to keep it for at least ten years after its introduction in the market.
What I will require the technical documentation of the Product in customs?
The short answer to this question, it would be not, but there's that qualify it to avoid the temptation not to do it or not do it correctly.
En general, las autoridades aduaneras de la Unión Europea no suelen exigir la documentación técnica al momento de la importación de productos. Su principal función es verificar la correcta declaración aduanera, asegurarse de que se cumplan los requisitos de importación y recaudar los derechos de aduana e impuestos aplicables. Normalmente suelen comprobar la legitimidad del producto pidiendo únicamente la declaración de conformidad y algún test en casos más concretos. Si bien es cierto que en contadas ocasiones (un porcentaje pequeño), nos hemos encontrado con petición de documentación técnica en aduanas, como puede ser el SDS.
However, it is important to note that the technical documentation can be requested by other competent authorities once the product is in the market of the European Union. For example, the market surveillance authorities may require this documentation as part of their control activities and monitoring to ensure that the products comply with the requirements of safety and quality requirements. As the own customs authorities may request, any part of the technical documentation, if you have evidence of non-compliance with regulations or any doubt with the customs declaration.
Requirements of the Technical Documentation for CE certification
The import of products within the European Union requires the fulfilment of a number of regulatory requirements, among which the technical documentation plays a crucial role. This documentation, which covers everything from the technical dossier, which includes the Declaration EU Compliance, which is essential to demonstrate that the products meet the applicable standards and regulations in the european market and has properly declared the conformity of the product to obtain the CE marking or CE certificate, if required.
Preparation and Presentation
Prior to introducing a product on the market, it is imperative that manufacturers prepare and maintain technical documentation. This should be available from the time the product is marketed and be preserved for at least ten years from its introduction in the market. In addition, the documentation must be presented to the market surveillance authorities at their request.
Content of the Technical File
The content and the complexity of the file or technical documentation, are always going to depend on the product with which you are working, although it can be generalized to a number of documents that will form part of our record:
-Name and address of the manufacturer or authorized representatives: Important this point about the authorized representative.
-Detailed description of the product.
-Unique identification of the product: This can be a serial number, batch or similar.
-Details of the design and manufacturing facilities.
-Declaration of the conformity assessment procedure: For this step we need to take it to the regulations applicable to our product, where you will establish that procedure must be followed for the assessment of conformity.
-Information on notified bodies: If the assessment of the conformity should be open to a notified body will reflect that at this point.
-Declaration of conformity with the relevant regulations.
-Identification of the applicable technical rules: Keep in mind that the technical standards and harmonized are not mandatory unless a standard is specified, and for this we must go back to the regulations specific for the product in question.
-Label and instructions for use.
-Results of tests performed.
-Identification of potential risks associated to the product.
-List of parts: A relationship of the components used in the manufacture of the product.
Importance of Translation and Update
It is essential that the technical documentation is available in the required language of the EU country in which the product was traded, there is also the option of the competent authority in case of require us documentation that we ask for the translation of the same prior to delivery. Also, this documentation must be up-to-date and reflect any changes in the design, manufacturing or regulatory standards.
Declaration of conformity
The Declaration of Conformity emerges as a document of vital importance in the process of ensuring compliance with the standards and european regulations. Although this document is essential, it is crucial to understand that by itself does not grant the european conformity of a product; rather, it is an integral part of the technical file, that covers a number of key documents that support the conformity of the product.
The Declaration of Conformity is issued by the manufacturer or his authorized representative and attests that the product complies with the essential requirements set out in the legislation of the EU. This document should include detailed information about the product, such as name, model, serial number, and an explicit statement that complies with the applicable standards and regulations. In addition, the Declaration of Conformity must be accompanied by the signature of the manufacturer or his authorized representative, confirming thus the responsibility of regulatory compliance.
Not to take lightly the signing of the declaration of conformity, as it involves the assumption of any liability on the part of the manufacturer or his authorized representative. When you put your signature on this document, the manufacturer is stating explicitly that the product complies with the essential requirements set out in the legislation of the EU and is committed to comply with all legal obligations related to its commercialization in the european market.
Also has legal implications significant. By signing this document, the manufacturer is accepting legal responsibility for the conformity of the product and agrees to respond to any breach of european regulations. This means that the manufacturer may be subject to legal action if it is found that the product does not comply with the established requirements.
In Together Comply to understand the complexity and the importance of compliance with the rigorous requirements of technical documentation and declarations of conformity for the import of products in the European Union. Our services are designed to offer you the assistance and support necessary to ensure that your products comply with all regulations and european regulations.
If you have questions about the regulations that apply to your product, the preparation of the technical documentation or on the validity of your test or laboratory testing, contact us and we will be happy to help you.
