Notified Body guidance on clinical evaluation.
Under the European Directives, manufacturers must demonstrate that medical devices are safe, perform as intended, and that any associated risks are acceptable. Where appropriate, these characteristics should be based on clinical data. This article discusses guidance documents developed to assist Notified Bodies in reviewing the manufacturer's evaluation of clinical data.
Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
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D002986:Clinical Trials as Topic; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D033161:Government Regulation; D017408:Guidelines as Topic; D012107:Research Design; D018570:Risk Assessment