European Medical Device Directive: impac
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J.D Kuyvenhoven; P Lahorte; K Persyn; E De Geest; P.W van Loon; F Jacobs; I Lema
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Article
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2001
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Elsevier Science
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English
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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