MDD (Medical Devices Direc-tive, 93/42 / EEC), the scope is very broad, including in addition to active implantable devices and in vitro diagnostic almost all medical devices, medical devices such as passive (dressing , disposable products, contact lenses, blood bags, catheters, etc.); and have borne medical devices, such as nuclear magnetic resonance, ultrasound diagnostic and therapeutic equipment, infusion pumps. The directive came into force on January 1, 1995, transition deadline June 13, 1998 from June 14, 1998 to enforce. After the formal implementation of directives, medical products with the CE mark can only be sold in the EU market. Manufacturers are designed to be used alone or in combination with any instrument, apparatus, equipment, materials or other items of the human body, including the necessary software, want to achieve the following situations: ● diagnosis, prevention, monitoring, treatment to reduce the disease ● Diagnostics, monitoring, treatment or dressing wounds or disability ● parts of the anatomy or physiology course of the investigation, replacement or repair ● contraception and these devices should not have pharmacological, immunological or metabolic action, but can have secondary functions.