The responsibilities of importers and distributors.
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.
Donawa
M E
ME
Donawa and Associates Ltd., Rome, Italy. donawa@srd.it
D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D006801:Humans; D008389:Marketing of Health Services; D011356:Product Labeling / Q000331:legislation & jurisprudence*; D011358:Product Surveillance, Postmarketing; D011640:Public Policy