European Medical Device Directive: impact on nuclear medicine

The European Council Directive 93/42/EEC concerning medical devices (14 Jun e 1993) assigns new responsibilities and imposes technical requirements bot h to the manufacturer and user of medical devices. In this paper the genera l outlines of the directive are discussed with a particular emphasis on the risk classification of products, the compliance and evaluation process and the CE-marking regulations. Furthermore, some practical implications are h ighlighted for devices and tools relevant to the field of nuclear medicine such as radiation detectors, gamma- and PET-cameras and software. (C) 2001 Elsevier Science Ltd. All rights reserved.