One of the most important criteria that distinguish a medical device from a medicament is its mechanical effect versus the chemical effect of the medicament. The current definition classifies orthopedic implants and surgical instruments as medical devices. Orthopedists, who practically have a close relationship with implants, had developed or designed many medical devices and surgical instruments. Orthopedists are in a very successful position in this field. Products with the CE mark provide free movement opportunities among European Union member countries. In our article, we aimed to clarify the necessary processes following medical device design.