title: Controls on clinical investigations in Europe: national differences.
abstract: 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.
authors.affiliation: MedPass International, Paris, France.
authors.forename: S
authors.initials: S
authors.lastname: Sorrel
mesh_terms: 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