Conformity assessment

Overview

A manufacturer must compile technical documentation with the evidence that his product is safe and complies with all EU legislation. One of the most important files in the technical documentation is the declaration of conformity. It is the manufacturer’s declaration that the product is safe, complies with all applicable EU legislation and that he takes full responsibility for the product.

Technical documentation

The manufacturer needs to compile technical documentation to be able to demonstrate that a product is safe and compliant. Technical documentation should contain the following:

1. The result of the pre-production risk management
2. A description of the product including different versions, if any, and the intended use
3. Construction drawings plus results of calculations and other investigations, if any
4. Test reports for all tests undertaken
5. A list of the standards that have been applied
6. The declaration of conformity
7. A copy of the marking plate and the user instructions
8. A description of the production control measures that the manufacturer has implemented

It is recommended that the manufacturer also includes a clear and well-structured table of contents to provide an easy overview of the documentation. The documents must be in one of the official EU languages. User instructions must always be in the language spoken in the country where the product is sold.

The technical documentation must be stored for ten years in such a way that the manufacturer on request can send it to a European market surveillance authority within ten days. The documents can be stored on a computer or on paper, whichever is preferable. The technical documentation can be stored anywhere and does not need to be stored in the EU. 

Declaration of conformity

The EU declaration of conformity is required for all CE-marked products and it is illegal to sell such products on the EU market without a proper EU declaration of conformity. The declaration must be stored in the EU and should include:

1. An identification of the product
2. An identification of the manufacturer and any authorised representatives including the full postal address
3. Detailed information about the product including a clear colour photo
4. A list of the directives that apply to the product
5. A list of the standards that have been applied to test the product
6. The manufacturer’s signature

Confidentiality

The descriptions in the technical documentation must show every detail of how the product is made. This should not cause concerns however, because only market surveillance authorities can demand to see the file and they are obliged by law to observe strict professional confidentiality. Manufacturers are not obliged to share the technical file with anyone else.