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The preservation of the CE mark for a medical device further to a maintenance process
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Pecchia, Leandro, Carpino, Giorgio, Mirarchi, Luciano and Bracale, Marcello (2009) The preservation of the CE mark for a medical device further to a maintenance process. In: 9th International Conference on Information Technology and Applications in Biomedicine, 2009. ITAB 2009., Larnaca, Cyprus, 5-7 Nov 2009. Published in: 9th International Conference on Information Technology and Applications in Biomedicine, 2009. ITAB 2009 pp. 1-4. ISBN 9781424453795. doi:10.1109/ITAB.2009.5394342
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Official URL: http://dx.doi.org/10.1109/ITAB.2009.5394342
Abstract
In this paper we analyze the conditions for the preservation of the CE mark of a medical device further to maintenance process, especially in the case in which the maintenance is managed by a third company. Analyzing the European Directives on medical devices, we observed that the conditions, in which the manufacturer obtained the CE mark, might change when another company manages maintenance. We propose three solutions to face this situation.
Item Type: | Conference Item (Paper) | ||||
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Subjects: | K Law [LC] > KJ-KKZ European law | ||||
Divisions: | Faculty of Science, Engineering and Medicine > Engineering > Engineering | ||||
Library of Congress Subject Headings (LCSH): | Medical instruments and apparatus -- Safety regulations -- European Union countries, Medical instruments and apparatus -- Labeling -- European Union countries, Medical instruments and apparatus -- Law and legislation -- European Union countries, Medical instruments and apparatus -- Standards -- European Union countries, Medical technology, Technology assessment | ||||
Journal or Publication Title: | 9th International Conference on Information Technology and Applications in Biomedicine, 2009. ITAB 2009 | ||||
Publisher: | IEEE | ||||
ISBN: | 9781424453795 | ||||
Book Title: | 2009 9th International Conference on Information Technology and Applications in Biomedicine | ||||
Official Date: | 2009 | ||||
Dates: |
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Page Range: | pp. 1-4 | ||||
DOI: | 10.1109/ITAB.2009.5394342 | ||||
Status: | Peer Reviewed | ||||
Publication Status: | Published | ||||
Funder: | Regione Campania | ||||
Conference Paper Type: | Paper | ||||
Title of Event: | 9th International Conference on Information Technology and Applications in Biomedicine, 2009. ITAB 2009. | ||||
Type of Event: | Conference | ||||
Location of Event: | Larnaca, Cyprus | ||||
Date(s) of Event: | 5-7 Nov 2009 |
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