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Gesetzesvorschriften der europäischen Union zu Medizinprodukten

Gesetzesvorschriften der europäischen Union zu Medizinprodukten

          
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About the Book

Masterarbeit aus dem Jahr 2017 im Fachbereich Medizin - Biomedizinische Technik, Note: 1,0, Sprache: Deutsch, Abstract: Im Rahmen der Arbeit wird ein Überblick über die Gesetzesvorschriften des aktuellen Entwurfs der europäischen Verordnung über Medizinprodukte gegeben. Ziel der Arbeit war es, die konsolidierte Fassung der Verordnung zu analysieren und die wesentlichen regulatorischen Änderungen darzulegen. Zusätzlich werden Hintergrundinformationen für die Revision der Medizinprodukteregularien erörtert und einige Mängel am derzeitigen Rechtssystem der Europäischen Union dargelegt. Durch die Wahl einer Verordnung als Rechtsakt, werden die Vorschriften für alle Mitgliedstaaten verbindlich sein und keine Umsetzung in nationales Recht erfordern. Die Ergebnisse der Untersuchung zeigen, dass vor allem benannte Stellen und Hersteller künftig deutlich mehr regulatorische Anforderungen zu erfüllen haben und damit in den nächsten Jahren sowohl ein größerer Aufwand, als auch höhere Kosten auf diese zukommen werden. Darüber hinaus wurde festgestellt, dass einige der mit der Verordnung verbundenen Ziele des Europäischen Gesetzgebers, wie z. B. einer erhöhten Produktsicherheit durch verschärfte Anforderungen und der gleichzeitigen Förderung innovativer Produkte, nur schwer miteinander in Einklang zu bringen sind. Insgesamt ließ sich dennoch beobachten, dass mit der Verordnung ein wesentlicher Schritt für die Transparenz gemacht wird und im Falle funktionsfähiger IT-Systeme, wie z. B. der Europäischen Datenbank für Medizinprodukte, künftig grenzüberschreitende Tätigkeiten besonders hinsichtlich der Überwachung des Medizinproduktemarkts einfacher möglich sein werden. Die Informationen dieser Arbeit sind prinzipiell für alle beteiligten Akteure im Medizinproduktemarkt bedeutend und helfen bei der Orientierung über die künftigen Anforderungen der Verordnung.


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Product Details
  • ISBN-13: 9783668444331
  • Publisher: Grin Verlag
  • Binding: Paperback
  • Language: German
  • Returnable: N
  • Weight: 168 gr
  • ISBN-10: 3668444331
  • Publisher Date: 29 May 2017
  • Height: 210 mm
  • No of Pages: 120
  • Spine Width: 7 mm
  • Width: 148 mm


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Gesetzesvorschriften der europäischen Union zu Medizinprodukten
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Gesetzesvorschriften der europäischen Union zu Medizinprodukten
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