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:
- use of the product
- the design
- the operation
- the traceability
- markings, labels, and user information
- risk assessments
- checks carried out and test reports
Who should create the technical file?
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.
Hire a consultancy agency
You need specialist knowledge for this step. You can hire a (commercial) consultancy agency to help you comply with all requirements. The information on this page gives a general overview of EU product safety legislation and applies to the European Economic Area. This includes EU Member States, Liechtenstein, Norway, and Iceland. And in some cases, also Switzerland and Türkiye. Extra rules may apply to your product in a particular country.
Make sure the technical file is readable
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. This can also be the second or third language of that country.
Keep the technical file
You must usually keep the technical file for a product for 10 years. 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.