What is conformity assessment procedure?

The conformity assessment procedure is one of the both most important elements of the New Legal Framework (NFL) directives. It aims in demonstrating that a product, before it is introduced to the market, complies with all essential requirements of the CE directives applicable to it, and in particular with those related to the user health and safety.

Many who don't have significant knowledge about CE marking may confuse conformity assessment with market surveillance, which refers to the control practised by the national authorities after a product is released on the EU market. However, both, conformity assessment and market surveillance, are complementary and equally necessary to ensure the appropriate functioning of the internal market.

The sectorial legislation specifies all the technical procedures that need to be followed when the conformity of a product is assessed. Each conformity assessment procedure consists of one or two conformity assessment modules. The conformity assessment procedure covers both design and production phases, while a module may cover either one of these two phases or both which, on the other hand, determines how many modules are included in the assessment.  All procedures, meant to demonstrate compliance with EU regulatory requirements, are considered as leading to the same level of conformity.