European Medical Device Directive: impact on nuclear medicine

JD Kuyvenhoven, P Lahorte, K Persyn, E De Geest, PW van Loon, F Jacobs, PP van Rijk, [No Value] Lemahieu, R A Dierckx

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    3 Citations (Scopus)

    Abstract

    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. (C) 2001 Elsevier Science Ltd. All rights reserved.

    Original languageEnglish
    Pages (from-to)207-212
    Number of pages6
    JournalComputerized medical imaging and graphics
    Volume25
    Issue number2
    Publication statusPublished - 2001
    EventSymposium on Frontiers in Nuclear Medicine Technology - , Belgium
    Duration: 6-May-19997-May-1999

    Keywords

    • CE-marking
    • medical device directive
    • European regulations
    • nuclear medicine
    • EC
    • European Free Trade Association

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