Technical Record and Technical Product Documentation

Introduction to the technical file

The import of products into the European Union (EU) involves a series of requirements and procedures that manufacturers (it is important to know clearly the definition of manufacturer) must comply with to ensure the safety and quality of their products. In this context, the technical file and technical documentation play a fundamental role.

The technical file is a set of documents that provides detailed information about the design, manufacture and operation of a product. It is essential to demonstrate compliance with requirements and regulations applicable in the EU market. From the conception of the product to its commercialization, the technical file records each stage of the process, ensuring traceability and transparency at all stages of production.

On the other hand, technical documentation comprises the necessary documents to support the product's compliance with EU standards and regulations. This documentation includes a variety of information, such as technical specifications, test results, compliance statements, and more. It is essential to obtain the CE Mark, which indicates that the product meets the legal requirements for its commercialization in the EU.

The preparation of the technical file and technical documentation must be carried out before the product is introduced to the market. This involves collecting and organizing all relevant information about the product, from its initial design to the results of compliance tests. In addition, it is crucial to keep it for at least ten years after its introduction to the market.

Will I be required to provide technical Product documentation at customs?

The short answer to this question would be no, but it must be nuanced to avoid the temptation not to do it or not to do it correctly.

In general, customs authorities in the European Union do not usually require technical documentation when importing products. Its main function is to verify the correct customs declaration, ensure that import requirements are met, and collect applicable customs duties and taxes. They usually verify the legitimacy of the product by asking only for the declaration of conformity and some tests in more specific cases. Although it is true that on rare occasions (a small percentage), we have encountered requests for technical documentation at customs, such as the SDS.

However, it is important to note that technical documentation may be requested by other competent authorities once the product is on the European Union market. For example, market surveillance authorities may require this documentation as part of their control and oversight activities to ensure that products meet established safety and quality requirements. Just as the customs authorities themselves may request some part of the technical documentation, if they have signs of non-compliance with the regulations or any questions with the customs declaration.

Technical Documentation Requirements for CE Certification

The import of products into the European Union requires compliance with a series of regulatory requirements, among which technical documentation plays a crucial role. This documentation, which ranges from the technical file, including the EU Declaration of Conformity, is essential to demonstrate that the products comply with the standards and regulations applicable in the European market and that the conformity of the product has been correctly declared to obtain the CE mark or CE certificate, if required.

Preparation and Presentation

Before introducing a product to the market, it is imperative that manufacturers prepare and have technical documentation available. This must be available from the moment the product is marketed and must be kept for at least ten years after its introduction to the market. In addition, documentation must be submitted to market surveillance authorities if requested.

Contents of the Technical File

The contents and complexity of the file or technical documentation will always depend on the product we are working with, although we can generalize a series of documents that will form part of our file:

-Name and address of the manufacturer or authorized representatives: This point is important about the authorized representative.

-Detailed description of the product.

-Unique product identification: This can be a serial number, batch number, or similar.

-Details of the design and manufacturing facilities.

-Declaration of the conformity assessment procedure: For this step, we must refer to the regulations applicable to our product, where it will be established what procedure we must follow for the assessment of conformity.

-Information on notified bodies: If a notified body is to be involved in the conformity assessment, this must be reflected at this point.

-Declaration of compliance with relevant regulations.

-Identification of applicable technical standards: It should be borne in mind that technical and harmonized standards are not mandatory unless a standard specifies it and for this we must go back to the specific regulations of the product in question.

-Label and instructions for use.

-Results of tests carried out.

-Identification of possible risks associated with the product.

-List of parts: A list of the components used in manufacturing the product.

Importance of Translation and Updating

It is essential that the technical documentation is available in the required language of the EU country in which the product is marketed, and there is also the option that the competent authority, if they request the documentation from us, will request a translation of the same prior to delivery. In addition, this documentation must be up to date and reflect any changes in 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 European standards and regulations. Although this document is essential, it is crucial to understand that it alone does not grant European conformity to a product; rather, it forms an integral part of the technical file, which encompasses a series of essential documents that support product compliance.

The Declaration of Conformity is issued by the manufacturer or its authorized representative and attests that the product meets the essential requirements established in EU legislation. This document must include detailed information about the product, such as its name, model, serial number, and an explicit statement that it complies with applicable standards and regulations. In addition, the Declaration of Conformity must be accompanied by the signature of the manufacturer or its authorized representative, thus confirming the responsibility for regulatory compliance.

Signing the declaration of conformity should not be taken lightly, as it implies the assumption of responsibility by the manufacturer or its authorized representative. By signing this document, the manufacturer is explicitly stating that the product complies with the essential requirements established in EU legislation and that it undertakes to comply with all legal obligations related to its commercialization in the European market.

It also has significant legal implications. By signing this document, the manufacturer is accepting legal responsibility for product compliance and undertakes 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 meet the established requirements.

At Together Comply, we understand the complexity and importance of complying with rigorous technical documentation requirements and declarations of conformity for importing products into the European Union. Our services are designed to offer you the necessary assistance and support to ensure that your products comply with all European regulations and regulations.

If you have questions about the regulations applicable to your product, the preparation of technical documentation or about the validity of your tests or laboratory tests, get in touch and we will be happy to help.