Self Certification MEDICAL DEVICE DIRECTIVE-CLASS I EUROPEAN UNION-ENTRY PACKAGE LEADS TO SELF-CERTIFICATION Manufacturers of medical devices who export their products to the European countries are responsible for meeting the requirements of the Medical Device Directive (MDD) by June 14, 1998. QNET offers affordable assistance through its EU ENTRY-PACKAGE. You will interface directly with our European certified lead assessors, with extensive experience in the medical device industry, gained at a leading medical research institute and Notified Body. EUROPEAN UNION-ENTRY PACKAGE CONTENT RISK CLASS DETERMINATION- A review of your devices to determine if they are indeed subject to the MDD; and if so, which risk classification applies. Devices are organized into groups in accordance with EN 15225 to minimize the quantity of technical files. TECHNICAL FILES- A systematic seven-step system is delivered via e-mail. This system has been designed to produce the required results within a minimum period of time. The steps are e-mailed in such sequence that repeat is eliminated and documentation is kept to a minimum. Numerous examples of documentation are provided. Unlimited support via phone, fax or e-mail is included during a two-month implementation period. SELF-CERTIFICATION Risk Class I devices only. Upon completion of the technical file you may issue a Declaration of Conformity which you place with your European Authorized Representative, QNET B.V. for Regulatory Affairs.