Update on the forthcoming European Clinical Investigation Standards.
The European harmonised standard for the clinical investigation of medical devices, published in 1993, will be replaced in 2003 by a new clinical investigation standard, which includes clearer guidance on the general requirements for medical device clinical investigations. In addition, another standard will also be published on clinical investigation plans. This article discusses the first of these two standards.
Donawa
Maria
M
Donawa and Associates Ltd, an Aventor Partner, Via Fonte di Fauno 22, I-00153 Rome, Italy. donawa@srd.it
D002986:Clinical Trials as Topic / Q000592:standards*; D004864:Equipment and Supplies / Q000941:ethics* / Q000592:standards*; D005060:Europe; D006801:Humans; D007391:International Cooperation; D008422:Materials Testing / Q000379:methods / Q000592:standards*; D011786:Quality Control; D013673:Technology Assessment, Biomedical / Q000941:ethics* / Q000379:methods / Q000592:standards* / Q000639:trends