Differing definitions of manufacturer
Donawa, M.E.
Medical Device Technology 9(6): 14-17
1998
ISSN/ISBN: 1048-6690 PMID: 10182120 Document Number: 489938
Medical device manufacturers marketing in the United States (US) and Europe must comply with different labelling requirements concerning the indication of manufacturer on the label. These differences are increased if US labelling requirements are compared with the practice of own-brand labelling under the European medical device Directives. This article discusses the differing requirements.