Manufacturers placing electronics products on the European Union market must prepare a technical file for CE marking.

The technical file is a collection of documents demonstrating that the product complies with applicable EU directives and harmonized standards.

It provides evidence that the product has been properly designed, tested, and evaluated according to regulatory requirements.

A well-prepared technical file helps manufacturers demonstrate compliance with directives such as:

• the EMC Directive (2014/30/EU)
• the Low Voltage Directive (2014/35/EU)
• the RoHS Directive (2011/65/EU)

If authorities request proof of compliance, the manufacturer must be able to provide the technical file within a reasonable timeframe.

This guide explains what a CE technical file is, what documentation it must contain, and how manufacturers can prepare it effectively.

Technical File for CE Marking - Quick Overview

• A technical file demonstrates compliance with EU product regulations.
• It contains design documentation, test reports, and risk assessments.
• The manufacturer must prepare the technical file before placing the product on the EU market.
• Authorities may request the technical file during regulatory investigations.
• Documentation must generally be retained for at least 10 years after the product is placed on the market.

What Is a Technical File for CE Marking?

A technical file for CE marking is a structured collection of documents that demonstrates a product complies with applicable EU directives.

It provides regulators with evidence that the manufacturer has assessed the product’s safety and performance and implemented appropriate compliance measures.

The technical file must allow authorities to understand:

• how the product is designed
• how it operates
• what risks were assessed
• what tests were performed

Technical documentation may also be referred to as:

• technical construction file
• technical documentation
• CE compliance documentation

For a broader explanation of documentation requirements, see our guide on Technical Documentation for CE Marking.

When Is a Technical File Required?

A technical file is required for most products that must bear the CE marking.

This includes many electronics products such as:

• consumer electronics
• industrial equipment
• smart devices and IoT products
• power supplies and electrical components

The technical file must be prepared before the product is placed on the EU market.

Even if authorities never request it, the documentation must still exist and be complete.

What Must a CE Technical File Contain?

The contents of a technical file depend on the applicable EU directives, but most technical files include the following elements.

Product Description

The technical file must clearly describe the product.

Typical information includes:

• product name and model number
• product category
• intended use
• product specifications

This allows regulators to understand how the product functions.

Design Documentation

Design documentation explains how the product was engineered.

Examples include:

• engineering drawings
• circuit diagrams
• component lists (bill of materials)
• product architecture diagrams

These documents help regulators understand the product’s design and safety considerations.

Risk Assessment

Manufacturers must evaluate potential hazards associated with their product.

Risk assessment typically evaluates:

• electrical hazards
• overheating risks
• electromagnetic interference
• mechanical risks

Risk mitigation measures must also be documented.

You can learn more in our guide on CE Risk Assessment for Electronics.

Test Reports

Testing demonstrates that the product complies with harmonized standards.

For electronics products, common testing includes:

• electromagnetic compatibility (EMC) testing
• electrical safety testing
• radio testing for wireless devices

Test reports issued by accredited laboratories are usually included in the technical file.

Harmonized Standards Applied

Manufacturers must identify the harmonized standards used to demonstrate compliance with EU directives.

These standards define the technical requirements used during product design and testing.

Examples include EMC and electrical safety standards.

EU Declaration of Conformity

The EU Declaration of Conformity (DoC) is a legal document stating that the product complies with applicable EU legislation.

The DoC must include:

• manufacturer identification
• product identification
• applicable EU directives
• harmonized standards used
• signature of the authorized person

You can learn how to prepare this document in our guide on Declaration of Conformity for CE Marking.

Who Is Responsible for the Technical File?

The manufacturer is responsible for preparing and maintaining the technical file.

If the manufacturer is located outside the European Union, documentation must still be accessible to EU authorities.

In some cases, documentation may be maintained through an EU Authorised Representative.

However, the manufacturer remains legally responsible for compliance.

How Authorities Review Technical Files

EU market surveillance authorities may request technical documentation during compliance investigations.

Authorities may review documentation when:

• investigating product safety complaints
• performing random market surveillance checks
• inspecting imported products

If documentation is incomplete or unavailable, regulators may take enforcement actions such as:

• product withdrawal from the market
• corrective actions
• administrative penalties

Maintaining a complete technical file is therefore essential.

How Long Must Technical Files Be Kept?

EU legislation generally requires manufacturers to retain technical documentation for at least 10 years after the product is placed on the EU market.

Documentation must remain available to EU authorities if requested.

This requirement applies even if the product is no longer actively sold.

Common Technical File Mistakes

Many compliance issues occur because technical documentation is incomplete or poorly organized.

Common mistakes include:

• missing risk assessment documentation
• outdated harmonized standards
• incomplete test reports
• missing Declaration of Conformity
• unclear product descriptions

You can learn more about these issues in our guide to Common Technical File Mistakes That Delay CE Compliance.

Best Practices for Preparing a CE Technical File

Manufacturers can improve compliance outcomes by following several best practices.

Recommended practices include:

• preparing documentation during product development
• organizing documentation in a structured format
• maintaining clear links between standards and test reports
• updating documentation after product changes

A well-organized technical file makes it easier to respond to regulatory requests.

How EcoComply Helps Prepare CE Technical Files

Preparing technical documentation can be complex, particularly for small and medium-sized manufacturers launching new products.

EcoComply helps manufacturers:

• identify applicable EU regulatory requirements
• structure technical documentation
• prepare compliant Declarations of Conformity
• coordinate compliance testing

This enables companies to prepare CE documentation faster and reduce compliance risks.

Regulatory References

• EU Market Surveillance Regulation (EU) 2019/1020
• EMC Directive 2014/30/EU
• Low Voltage Directive 2014/35/EU
• European Commission CE Marking Guidance