CE markiing(also known as CE mark)is a mandatory conformance mark on many products placed on the market in the European Economic Area(EEA).With the CE marking on a product the manufacturer ensures that the product is in conformity with the essential requirments of the applicable EC directives.The letters"CE"stand for European Conformity.
The main goals of the CE Marking are to:
— Indicate a product's conformity with the "essential requirements" of the directives.
— Allow products to be "placed on the market"
— Ensure the "free movement of goods"
— Allow the "withdrawal of non-conforming products"by customs and enforcement authorities.
Scope of the directives:
There are three European CE marking directives that specifically apply to medical devices manufacturers:
— The Medical Devices Directive(MDD)applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive.
— The Active Implantable Medical Devices Directive(AIMDD)applies to all active and related accessories intended to be permanently implanted in humans.
— The In Vitro Diagnostics Directive(IVDD)applies to all devices and kits used away from the patient to make a diagnosis of patient medical conditions.