Why CE Mark?

The CE mark is required for a variety of products in order to be legally placed on the market in the European Union.

The EU Commission says "By affixing the CE marking on a product, the manufacturer declares on his/her sole responsibility that the product is in conformity with the essential requirements of the directives that apply to it and that the relevant conformity assessment procedures have been fulfilled. Thus products bearing the CE marking benefit from free circulation in the European Market".

The required declaration of product properties are laid down in European norms (EN) standards issued by CEN European commission for  standardisation. You can find information on CE marking tailored for manufacturers, importers, distributors and consumers.

CE mark is administered in a very different manner when compared between different product groups. This regards both how challenging the specifications are, and how stringent the monitoring and control by independent certification and inspection agencies, so-called Notified Bodies. Any Notified Body has to be approved by a EU member state. The approval is valid only for a certain, well-defined area.

New approach CE marking Directives

The declaration of conformity and the CE marking are the two instruments which allow the free circulation of products within Europe. The need of removal of technical barriers which obstruct the free circulation of products is already established in the " Rome's Treaty" of 1957. Since 1985 many directives specifying properties of products followed the "General Approach" which:  

• Asserts the principle according to which the needs of safety, health, and environmental prevention has to be harmonized in Europe
• Affirms that a product which is legally commercialized in a member state can be commercialized also in other members's states
• Fixes the essential requirements of health, safety and environmental prevention
• Identifies, through harmonized standards, how to satisfy some or all the requirements requested by directive
• Specifies that the harmonized standards have to be transposed into national standards
• Assigns to manufacturer the responsibility to issue the CE Declaration of conformity and to affix the CE marking
• Introduces the principle of presumption of conformity for the products which are CE marked and which are accompanied by Conformity's Declaration

From 1993 the directives, written according to the "New Approach", have introduced the modular scheme, which identifies in general principles and procedures for the conformity's evaluation and for the CE markings apposition. The conformity's evaluation can be attested though one or more certifications, according to the referring directive. With the exception of particular modules, all certifications require the involvement of a Notified Body which, according to the provided process, can:

• Verify and approve the conformity to requirements through exams and/or tests on product
• Approve and supervise the system of warranty of the quality of the manufacturer.

View our list of Notified Body services or contact your local Eurofins E&E or Industrial laboratory to access all of our CE marking services.