European directives and technical standards for medical equipment

Inside European Union (EU) nations a consensus has been reached in order to obtain precise rules for the regulatory and standards definitions of medical equipment and devices. Such a decision has created a certain number of procedures to be fulfilled by manufacturers, political authorities, notified bodies, clinical engineering departments and others in a very important qualitative and quantitative market like Europe is. Some fundamental steps in this very complex approach of regulatory affairs are described in this paper.