If you are planning to sell a product in the European Union, you have probably come across the term Technical File. Many manufacturers assume that obtaining a CE mark is simply a matter of product testing, but in reality, technical documentation is one of the most important parts of demonstrating compliance.
A Technical File is a collection of documents that shows how your product complies with the applicable European legislation. It provides evidence that you have identified the relevant legal requirements, assessed the risks, verified compliance through testing where necessary, and prepared the required documentation.
Depending on the product, a Technical File may include:
- Product description and specifications
- Design drawings and manufacturing information
- Risk assessment
- Test reports
- Applicable directives and harmonised standards
- User manual and product labels
- EU Declaration of Conformity
The exact contents depend on the legislation that applies to your product. For example, a wireless IoT device will require different documentation than a toy, a medical device or a piece of industrial machinery.
One of the most common mistakes manufacturers make is waiting until the end of product development before preparing the Technical File. By considering compliance requirements early in the design process, companies can often avoid unnecessary testing, redesigns and delays when entering the market.
It is also important to understand that a Technical File is generally not submitted to the authorities before placing a product on the market. Instead, manufacturers must keep the documentation available and provide it to market surveillance authorities upon request.
Preparing complete and accurate technical documentation is one of the key responsibilities of manufacturers placing CE-marked products on the European market.
If you are unsure what documentation your product requires, a compliance assessment at the beginning of your project can help identify the applicable legislation, standards and documentation obligations before significant development or testing costs are incurred.