Core Issue: Relationship Between CE Technical File and Test Report

The CE Technical File and Test Report are two interrelated but functionally different document types in the CE compliance system. The Technical File (Technical File / Technical Documentation) is a comprehensive archive prepared by the manufacturer to demonstrate that the product meets the requirements of applicable directives/regulations. It typically includes product description, design drawings, risk assessment, instructions for use, Declaration of Conformity, etc. The Test Report is part of the Technical File and is used to show test results against specific standards (e.g., EN standards). A Test Report is not the entirety of the Technical File; it is one element of supporting evidence.

Applicable Product Examples and Scenarios

The relationship discussed in this article applies to various products requiring CE marking, including but not limited to: electrical and electronic equipment (e.g., LED luminaires, IT equipment), machinery, toys, personal protective equipment, medical devices (low-risk), construction products, etc. When exporting to the EU or EEA member states, or to the UK under the UKCA regime, manufacturers must prepare a complete Technical File and, where necessary, have Test Reports available.

Common Misconceptions Clarified

Misconception 1: A Test Report equals a Technical File. Fact: A Test Report only demonstrates results for specific tests; the Technical File contains additional items such as risk assessment and production records. Providing only a Test Report is usually insufficient to meet compliance requirements.

Misconception 2: A Technical File does not need to include a Test Report. Fact: Most CE directives/regulations require products to be tested against harmonized standards. The Test Report is key evidence of conformity and should generally be included in the Technical File.

Misconception 3: A Test Report covers all EU countries. Fact: Test Reports are typically based on specific standards, while different EU member states may have additional requirements for certain products. The validity of a report depends on product category, applicable regulations and market surveillance authority requirements.

Document Preparation Suggestion Checklist

The following is a common checklist for preparing Technical Files and Test Reports. The final list depends on product category and applicable regulations:

  • Test Report: Issued according to applicable standards (e.g., EN 60598, EN 55014, etc.), showing clear standard numbers, test methods, results and report number.
  • Technical File: Including product description, drawings, component list, risk assessment report, instructions, labels, Declaration of Conformity (DoC), etc.
  • Declaration of Conformity (DoC): Signed by the manufacturer, declaring conformity with relevant regulatory requirements.
  • Other supporting documents: Such as FCC or EN 300 328 reports for wireless modules, REACH or RoHS declarations for chemical substances (depending on product category).

Platform Review Scenarios and Risk Note

When undergoing CE compliance review on e-commerce platforms such as Amazon or TEMU, the platform may request Technical Files or Test Reports. Please note:

  • Different platforms may have varying requirements on document type and detail; the platform retains final review authority.
  • The validity of a Test Report depends on product changes, standard updates and platform rules. This article serves as reference for document preparation and does not guarantee platform acceptance.
  • For the CE/UKCA compliance route, whether a notified body must be involved depends on the product category and applicable conformity assessment procedure (most low-risk products may be self-declared by the manufacturer).

It is recommended to first confirm the applicable directives/regulations (e.g., LVD, EMC, MD, RED) for the product, and select a competent testing laboratory to issue the report.

Next Step Document Recommendation

If you need to evaluate the completeness of your product’s CE Technical File or obtain a Test Report, we recommend contacting a qualified testing and certification organization for a pre-review. A pre-review can help identify documentation gaps and reduce review risks.