How to Prepare Technical Documentation for CE Marking (2025 Guide)

Before a product can legally bear the CE marking and be sold in the European Union, manufacturers and importers must prepare complete technical documentation for CE marking, also known as the Technical File.

This documentation proves that a product complies with all relevant EU legislation and standards. It’s not just a formality; it’s the foundation of compliance.
In this guide, we explain what the technical file must include, who is responsible for it, and how to prepare it efficiently for 2025 and beyond.

1. What Is Technical Documentation?

The Technical Documentation (or Technical File) is a set of documents that demonstrate the product’s conformity with applicable EU directives or regulations.

It must contain evidence that the product:

• Has been designed, manufactured, and tested in accordance with EU requirements, and
• Meets essential health, safety, and environmental standards.

Although this documentation is not submitted automatically to authorities, it must be made available upon request for at least 10 years after the product is placed on the market.

2. Who Must Prepare It?

Responsibility lies with:

• The manufacturer, if based in the EU.
• The importer, if the manufacturer is located outside the EU.

In some cases, an Authorized Representative in the EU may hold the documentation on behalf of a non-EU manufacturer.
Importers should always verify that the technical file exists and is complete before placing any product on the EU market.

3. What Should the Technical File Include?

Although exact requirements vary depending on the directive or regulation, a complete technical file typically includes:

1. Product description and intended use
2. Design and manufacturing drawings
3. Bill of materials and key components
4. List of applied directives and standards
5. Risk assessment
6. Test reports and certificates
7. Quality control procedures
8. User manuals, labels, and warnings
9. Declaration of Conformity (DoC)

The more complete the file, the easier it is to demonstrate conformity if requested by market surveillance authorities.

4. Common Mistakes to Avoid

Even experienced manufacturers make errors when preparing technical documentation.
Some of the most frequent include:

• Using outdated or non-harmonized standards
• Missing test reports or incomplete DoC
• Failing to update documentation after design or component changes
• Not keeping translations of instructions and labels in each EU language

Each of these can lead to non-compliance and potential product recalls or fines.

5. How to Keep It Updated

Technical documentation is not static.
Whenever there’s a:

• Change in product design,
• Update in EU directives or standards, or
• New market risk,

…the file must be reviewed and updated accordingly.
Manufacturers should establish a document control process to ensure that only the latest, approved versions are stored and easily retrievable.

6. How GoEasy Compliance Can Help

Preparing a complete and compliant technical file takes time and precision, especially when managing multiple product lines.

At GoEasy Compliance, we assist manufacturers and importers by:

• Reviewing or creating technical documentation,
• Mapping applicable EU directives and standards, and
• Drafting or verifying the Declaration of Conformity.

Our experts ensure your documentation is ready for audits, inspections, and market surveillance, saving you time and reducing risk.

The technical documentation is more than just paperwork; it’s the backbone of CE marking compliance.
Having a complete, accurate, and up-to-date technical file ensures the safety, reliability, and legal access of your product to the European market.

With GoEasy Compliance, achieving and maintaining full EU compliance has never been easier.

GoEasy Compliance streamlines the process of preparing CE-ready technical documentation. We identify the applicable EU requirements, organize the documents you need, and make sure everything is complete, consistent, and ready for market launch.

We can build or review your technical file, prepare your Declaration of Conformity, and support you with labels, manuals, and any updates required over time.

Our goal is simple, fast, and clear: a complete, compliant technical documentation package that helps you enter the EU market without unnecessary delays.