RESUMO
The absence of a pan-European regulatory framework for medical devices incorporating human tissues is causing difficulties for the growing number of manufacturers of these products. France has implemented strict legislation in this area and is spearheading an effort for Member States to adopt similar measures. This article looks at the status of French regulations, which form the basis of its recent proposal to the European Commission for a new Directive on human tissues.
Assuntos
Equipamentos e Provisões/normas , Política Pública , Bancos de Tecidos/legislação & jurisprudência , Ética Médica , França , Humanos , Segurança , Extratos de Tecidos/normasRESUMO
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.
