Create a technical file

What is a technical file?

The technical file (technisch dossier) contains all the information about your product. This information shows that the product meets the legal requirements for product safety. For example, the technical file contains information on:

• risks when using the product (risk analysis)
• the product rules that apply
• the use of the product as intended
• the design and important characteristics of the product
• the production
• the functionality
• how to ensure that serialised products are safe and traceable
• the markings, labels and user information
• checks and test reports carried out
• the product standards, test reports, and certificates that exist

Who should create the technical file?

The manufacturer of the product must prepare the technical file and make it available to importers and distributors of the product.

How do you create a technical file?

What should be in the technical file depends on the product type and which regulations apply to your product. You need to check which EU legislation applies to your product. And what the main requirements are that the product must meet.

You make sure your product meets these requirements. And in the technical file, you set out in detail what standards you have used, and which technical specifications ensure that your product is safe.

Make sure the technical file is readable and understandable

Anyone dealing with your product must be able to read and understand the technical file. EU legislation states that the technical file must be written clearly in a language used in the country where the product is sold.

Keep the technical file

You must usually keep the technical file for a product for 10 years, on paper or digitally. For some products, you must keep the technical file for 20 years. This applies from the time the product was put on the market. This is the responsibility of the manufacturer or an authorised representative in the EU.

Keep the technical file up to date

You must update the technical file if the design of the product changes. You must also reassess whether the product is safe and meets all legal requirements. This is known as conformity. The technical file must include all versions of the product. You must describe all changes to the product and the differences between the versions. And you must describe how the different versions were assessed to meet the safety requirements.