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European Medical Device Directive: impact on nuclear medicine

✍ Scribed by J.D Kuyvenhoven; P Lahorte; K Persyn; E De Geest; P.W van Loon; F Jacobs; I Lemahieu; R.A Dierckx; P.P van Rijk

Publisher
Elsevier Science
Year
2001
Tongue
English
Weight
72 KB
Volume
25
Category
Article
ISSN
0895-6111

No coin nor oath required. For personal study only.

✦ Synopsis

The European Council Directive 93/42/EEC concerning medical devices (14 June 1993) assigns new responsibilities and imposes technical requirements both to the manufacturer and user of medical devices. In this paper the general 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 highlighted for devices and tools relevant to the field of nuclear medicine such as radiation detectors, gamma- and PET-cameras and software.

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