Medical Devices Directive 93/42/EEC
It is a sign of unity indicating that the products covered by the New Approach Directives prepared within the scope of the New Approach Policy adopted by the European Union in 1985 within the framework of the harmonization of the technical legislation are in compliance with these directives and passed all necessary conformity assessment activities.
It is an authorization which gives the right of free movement of products with CE mark in the European market. In other words, the CE mark is the passport of the product.
CE marking of a product identified; health conditions, safety conditions, consumer protection and environmental protection requirements, and that the manufacturer complies with these requirements.
A product bearing the CE marking meaning; human safety, life and property safety, human health, environmental protection, energy saving. Producers must have CE marking in order to sell their products in European Union countries.
Is CE Mark Required for my product?
According to the directives issued by the European Union, your product should be inspected and if there is a directive about your product, you may need to obtain CE mark.
The CE mark applies only to products covered by the directives issued by the European Union. CE marking is not required for products outside the scope of the Directive.