User reporting systems.

M E Donawa

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PubMed · 10176361

User reporting systems.

M E Donawa

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Abstract

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.

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Equipment Failure Equipment and Supplies European Union Guidelines as Topic Humans Product Surveillance, Postmarketing Risk Management Journal Article

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M E Donawa. 1997. User reporting systems.. https://pubmed.ncbi.nlm.nih.gov/10176361/

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