Technical file for CE

 

The technical documentation provides information on the design, manufacture and operation of a product and must include all the elements required to demonstrate that the product complies with the applicable requirements.

If you are a manufacturer, there are certain rules you must follow when placing a product on the market you must:

• prepare the technical documentation before placing the product on the market

• ensure that market surveillance authorities have access to the technical documentation (if requested) once the product is placed on the market

• keep the technical file for 10 years from the date of placing the product on the market (unless expressly stated otherwise)

The technical file is necessary to demonstrate that the product complies with the essential requirements and therefore to justify and support the EU declaration of conformity. You need this file to affix the CE marking to the product.