The responsibilities of importers and distributors
Donawa, M.E.
Medical Device Technology 9(7): 12-14; 16-18
1998
ISSN/ISBN: 1048-6690 PMID: 10186979 Document Number: 494806
The European Directives for medical devices impose significant responsibilities on manufacturers, Member States and Notified Bodies. However, the Directives define far fewer responsibilities for importers and distributors. As a result, manufacturers and distributors do not always have a clear concept of these responsibilities nor of those specified by national laws and regulations. This article will discuss these responsibilities and some issues that should be considered in determining them.