Before the CE marking can be affixed to the product, the manufacturer must follow certain procedures. These procedures may differ for each directive and each product. The following procedures may be applicable: declaration of conformity; compiling a technical construction file: applying for and filing an EC Type-examination certificate; compiling a users manual; and affixing the CE marking.
1. Declaration of Conformity
The declaration of conformity must contain the following information:
- product identification;
- the EU directives complied with;
- standards used to verify compliance with the directives;
- name of notified body if required by the directive;
- be signed by or on behalf of the manufacturer or the authorized representative and identify that signatory;
- the manufacturer's name and address.
2. Technical Construction File (TCF)
Most directives impose an obligation for the manufacturer or the authorized representative to provide a technical file that demonstrates the technical basis for conformity of the product to the requirements of the directive. The manufacturer must implement internal measures to ensure that the product remains in conformity. The file is intended essentially for national surveillance authorities.
The TCF must be kept at the disposal of national surveillance authorities for inspection and control purposes, and be available for at least ten years, starting from the production date of the final product. The main elements comprising a TCF are the following:
- Declaration of Conformity;
- a general description of the product;
- design and production drawing and diagrams;
- detailed technical data for essential aspects of the product;
- list of standards and or solutions applied;
- report of calculations and tests that have been carried out;
- certificate and inspection reports;
- in case of series production, the internal conditions that have been observed to safe-guard compliance with the directive;
- CE user manual.
3. CE Users Manual
The directives usually have a direct relation to user safety. Information provided to a user plays an essential role in avoiding or reducing safety risks. Thus, a users manual is often an essential safety requirement. If not available in-house, it is advisable to seek technical and legal assistance in compiling the CE users manual. A users manual must contain all the information required for the correct and safe use of a product, including:
- information on risks;
- identification and discouragement of hazardous applications;
- instructions on how the product can be put to safe use;
- set out who is authorized to perform certain actions;
- identification of appropriate safety precautions have to be taken.
- The CE users manual must be drawn up in the language of the country or countries in the EEA into which the product is imported and in the language of the country or countries in the EEA where the product is to be used.
