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. How to obtain medical devices "safety certification mark" below to get the CE certification as an example: the product to be passed CE certification, you need to do work in three areas. First, collect and certification of products related to EU technical regulations and European (EN) standards, through digestion, absorption, into the enterprise product standards. Second, enterprises in strict accordance with the above product standards of production, that is, the above-mentioned technical regulations and EN standards, carry out the whole process of product design and development business and manufacturing. Third, companies must follow standard ISO9000 + ISO13485 quality system maintenance and construction, and obtained ISO9000 + ISO13485 certification.