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Los nuevos reglamentos de la Unión Europea sobre productos sanitarios
4 de mayo, 2017
En este documento se exponen los principales rasgos de los dos nuevos reglamentos de la Unión Europea sobre productos sanitarios, ya aprobados y pendientes de publicación en el Diario Oficial.1. Preliminar
1.1. En la actualidad, los productos sanitarios son regulados en la Unión Europea por tres directivas aprobadas en la década de los noventa del pasado siglo: a) la Directiva 90/385/CEE del Consejo, de 20 de junio de 1990, relativa a la aproximación de las legislaciones de los Estados miembros sobre los productos sanitarios implantables activos; b) la Directiva 93/42/CEE del Consejo, de 14 de junio de 1993, relativa a los productos sanitarios, y c) la Directiva 98/79/CE del Parlamento Europeo y del Consejo, de 27 de octubre de 1998, sobre productos sanitarios para diagnóstico in vitro…
Los nuevos reglamentos de la Unión Europea sobre productos sanitarios