Controls on clinical investigations in Europe: national differences.
Clinical investigations in Europe of non-CE-marked medical devices are subject to the controls imposed by the European Directives. At the national level, this creates problems for manufacturers primarily because of country-to-country differences in transposing the Directives into national laws. This article will illustrate some of these differences using two case studies.
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MedPass International, Paris, France.
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation