User reporting systems.
Under the European vigilance system, manufacturers are responsible for reporting serious incidents or near incidents concerning medical devices to the relevant Competent Authority. However, the European Directives do not require users to report incidents. As a result, user reporting requirements vary among Member States. This article examines the manner in which user reporting is addressed in the European Directives and European vigilance guidance document, some examples of national user reporting systems, and some important issues concerning user reporting.
Donawa
M E
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Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
D004868:Equipment Failure; D004864:Equipment and Supplies / Q000009:adverse effects*; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D012308:Risk Management / Q000592:standards*