The main requirement for products manufactured within the EU, as well as supplied to the European Union from third countries, is their complete safety and harmlessness when used by humans, animals, property, and the environment.

Fundamental safety requirements for different types of products are addressed in the relevant EU Directives, as well as European and international standards.
The conformity assessment procedure (certification) involves a specific sequence of actions, after which the manufacturer marks the product with the CE mark and, under their personal responsibility, guarantees and declares that the manufactured product fully complies with the requirements of EU Directives and harmonized European standards. This manufacturer’s declaration is called the EU Declaration of Conformity.

Estrafin Consulting OY will assist the product manufacturer in preparing the documentation package for the EU Declaration of Conformity, including the following set of tasks:

• Preparation of the technical documentation (Technical File) for the product;
• Conducting conformity assessment by a competent body according to EU Directives and standards;
• Test results confirming that the product complies with European standards;

 

By completing the above tasks and possessing the necessary documents and test protocols certified by notified EU bodies, the manufacturer or exporter can freely supply and sell the products on the markets of the European Union countries.