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Grundlagen des europäischen Medizinprodukterechts

Grundlagen des europäischen Medizinprodukterechts

          
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About the Book

Diplomarbeit aus dem Jahr 2011 im Fachbereich Jura - Zivilrecht / Handelsrecht, Gesellschaftsrecht, Kartellrecht, Wirtschaftsrecht, Note: 1,1, Hamburger Fern-Hochschule, Sprache: Deutsch, Abstract: Diese Abhandlung eigent sich sehr gut für alle Personen, die sich einen aktuellen Überblick über das Medizinprodukterechtssystem im EWR und der Schweiz verschaffen möchten. Vorkenntnisse sind nicht zwingend notwendig. Inhalt der Arbeit: Es ist verständlich, dass für Medizinprodukte strenge regulatorische Anforderungen gelten müssen. Dies bezieht sich sowohl auf die Entwicklung und Herstellung, als auch auf die Marktbeobachtung, Anwendung und Instandhaltung der Produkte. Die Basis des Medizinprodukterechtssystems stellen dabei drei europäische Richtlinien dar: 1. Richtlinie 90/385/EWG über aktive implantierbare medizinische Geräte 2. Richtlinie 93/42/EWG über Medizinprodukte 3. Richtlinie 98/79/EG über In-vitro-Diagnostika Auf diese drei Richtlinien wird in dieser Arbeit näher eingegangen werden. In dieser Arbeit soll zunächst der Begriff des Medizinprodukts genau definiert, und Medizinprodukte von anderen ähnlichen Produkten abgegrenzt werden. Danach werden zwei Lebenszyklusmodelle für Medizinprodukte dargestellt, um dem Leser einen ersten Überblick über die Thematik zu verschaffen. Anschließend wird das Rechtssystem für Medizinprodukte im Europäischen Wirtschaftsraum als solches näher beleuchtet, um eine ganzheitliche Sicht auf das System zu erhalten. Dabei soll vor allem auf die CE-Kennzeichnung und deren Bedeutung eingegangen werden. Damit der gesamte europäische Raum erfasst wird, soll auch kurz auf die Situation in der Schweiz eingegangen werden. Der Entstehung und Entwicklung des heutigen europäischen Rechtsrahmens wird ein eigenes Kapitel gewidmet. Anschließend folgt eine kurze Beurteilung des Rechtssystems, vor allem im Vergleich zum US-amerikanischen System. Diese Voranalysen sind notwendig, um die zukünftige Entwicklung des Medizinprodukterechtssystems be


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Product Details
  • ISBN-13: 9783656218005
  • Publisher: Grin Verlag
  • Binding: Paperback
  • Language: German
  • Returnable: N
  • Spine Width: 6 mm
  • Width: 148 mm
  • ISBN-10: 3656218005
  • Publisher Date: 19 Jun 2012
  • Height: 210 mm
  • No of Pages: 92
  • Series Title: German
  • Weight: 131 gr


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