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The EC medical devices directives

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1 Author(s)
Freeman, M. ; Comm. of the European Commun., Brussels, Belgium

The reasons why directives in the field of medical devices are required are outlined. It is argued that if one market is to be created in Europe in which medical devices from one country are to be acceptable for use in the other member states, the basic safety and performance requirements must be met. The ways in which the medical device directives address this problem and the forms this legislation takes are reviewed.<>

Published in:

Engineering in Medicine and Biology Magazine, IEEE  (Volume:12 ,  Issue: 2 )