Technical file

Definition

The technical file for a product is the compilation of documents that the manufacturer must collate to provide evidence that the conformity assessment process has been carried out, and that the product is safe and complies with all relevant EU legislation.

The requirements relating to the technical file are described in an annex (called ‘Contents of Technical documentation’) to the applicable product safety legislation.

General requirements and obligations

A number of general requirements apply to technical files for consumer products:

• Language:
  • The documents in the technical file can be in any of the official EU languages, including English.
  • The EU Declaration of Conformity must be written in the language(s) spoken in the country where the product is sold.
  • User instructions and warnings must always be written in the language(s) spoken in the country where the product is sold. It is not sufficient only to have warnings and instructions written in English.
• Storage of the technical file:
  • The technical file must be stored for 10 years after the last item of the product has been sold.
  • The file can be stored on a computer, on paper or in other formats as preferred by the manufacturer.
• The manufacturer must be able to send the technical file or any part of it to a European market surveillance authority within 10 days upon request.

In certain circumstances (see the Using a third party factsheet) the product must be sent to a Notified Body for an EC-type examination. In such cases, the following elements are added to the technical file:

• copies of documents that the manufacturer has submitted to the notified body;
• a copy of the EC-type examination certificate.

Contents of the technical file

There are small differences from one directive to another, so it is always essential to check the requirements of the applicable legislation. However, by way of example, the following illustrates the information required in relation to two product categories, toys and electrical products:

Toys

The technical file for a toy shall contain the following information:

• a detailed description of the design and manufacture of the toy;
• a list of components and materials used in the toy;
• safety data sheets on chemicals used in the toy;
• a pre-market risk assessment including an analysis of the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards that the toy may present;
• a description of the conformity assessment procedure followed;
• a copy of the EC declaration of conformity;
• the addresses of the places of manufacture and storage;
• test reports that show that the toy conforms with the harmonised standards;
• a description of the means for production control that has been implemented by the manufacturer.

Electrical products

The technical file for electrical products shall contain the following information:

• the result of the pre-production risk management;
• a description of the product and any variants including a description of the intended use;
• detailed construction drawings plus results of calculations and other investigations, if any, including the explanations that may be necessary to understand the drawings and other information;
• test reports for all tests undertaken (for electrical products to demonstrate that the product is in compliance with the Low Voltage Directive, the EMC Directive and the ROHS Directive);
• for products that fall under the energy regulations, test reports that demonstrate that the product complies with the ecodesign regulation and the implementing measures;
• for products where energy labelling is required, test reports or other documentation that are used to determine the energy class;
• a list of the harmonised standards and other standards and technical specifications that have been applied;
• a copy of the signed and dated EU declaration of conformity;
• a copy of the marking plate and the user instructions for the product;
• a description of the production control measures that the manufacturer has implemented.

The manufacturer may include other documents in the technical file if appropriate. It is recommended to include a clear and well-structured table of the contents of the file and a list of changes to the product including the manufacturer’s analysis of the consequences of the change on the safety of the product.

Further guidance

General guidance on technical documentation:

• The ‘Blue Guide’ on the implementation of EU product rules 2020

For toys:

• Technical documentation guidance document in English.
• Technical documentation guidance document in Chinese.
• More guidance documents on toys are found on the “Guidance on Toy Safety” webpage.

For electrical products:

• LVD 2014/35/EU – Guidelines on the application of the directive – August 2018.

Related topics

• CE marking
• Conformity assessment
• Declaration of conformity
• EU consumer protection
• EU market surveillance
• Product safety checklist
• Recall procedures
• Risk management
• Safety Gate / RAPEX
• Selling online
• Testing
• Using a third party

You may also visit the SPEAC ACADEMY to learn more about the EU Safety requirements.