Compiling a technical file is a critical step in the CE marking process, but it can be a time intensive procedure. In many cases, more than one EU Directive applies to a product, and translating this into requirements for the technical file can be a challenge. To avoid delays during CE marking, here’s what you should keep in mind when preparing a technical file.
What is a technical file?
The Technical File (TF) or Technical Documentation is a set of documents that contains all of the relevant information of a specific product, including information about its:
The main purpose of the Technical File is to demonstrate that a product complies with the applicable EU Directive(s) for health and safety. Before a manufacturer can affix the CE mark to their product, they must prepare a technical file which proves that their product complies with the relevant EU safety standards.
Why is proof of compliance important?
It is mandatory for manufacturers to ensure that their products are safe to use before they are put on the market. The technical file acts as a record that the manufacturer has properly identified the applicable CE directives and carried out the necessary conformity assessment procedures to verify compliance.
This is particularly important if liability claims or recalls are made and the manufacturer, importer or distributor is held accountable. The Technical File can be requested by authorities at any point, even years after the manufacture of a product, to verify compliance.
For how long should the technical file be kept?
The Technical File must be made available to the competent authorities of the Member States for at least 10 years following the date of manufacture. In the case of series manufacture, it should be kept for 10 years following the date that the last unit was produced.
Which documents must be included in the technical file?
The required contents of your technical file are determined by the legislation that your product must meet. Each EU Directive has its own set of requirements for the technical file, from the type of document to the included information. In general, the technical file includes the following:
- A general description of the product
- A risk assessment (if needed) to determine the safety and health requirements applicable to the product
- Design and production drawings
- Detailed technical drawings outlining the essential aspects of the product
- List of the applicable CE directives and requirements for health and safety
- Report of performed calculations and tests to ensure compliance
- Certificates and test reports
- Information for the user (User’s manual, labelling and packaging)
For series production, the internal stipulations that were complied with to guarantee conformity with the Directive(s) must also be included in the technical file. Please note that the required documentation varies per directive and regulation. It is possible that some of the above mentioned documents are not applicable to your product.
Prepare your technical file quickly and efficiently
Certification Experts can provide support throughout the entire CE marking process or clarify specific concerns you might have about the technical file. Here’s how we help you save time when preparing a technical file:
- Identify applicable EU Legislation
- Determine whether a risk assessment is necessary
- Make a list of required documents based on the applicable directives
- Conduct a complete technical documentation review
- Verify third-party certificates
- Identify gaps or missing information
- Final review of documentation, labeling, packaging and instructions for use
To get started today with the technical file, contact us. We will conduct a thorough documentation review to ensure that your technical file contains all of the required information.