NLMedicalDevices object
Act on Medical Devices (or comparable national legal framework)
Clinical trials on MD in France are covered by:
LOI no 2004-806 du 9 août 2004 relative à la politique de santé publique (complétée par le décret 2006-477 du 26 avril 2006).
This law (following the “Huriet - Sérusclat” Law) has to be regarded for all biomedical research involving human beings. It is part of the Code de la Santé Publique/CSP (see: Code de la santé publique - Titre II Recherches biomédicales).
Additional Information
NB: The “Jardé” Law, regulating research on human beings and promulgated on March 5th, 2012, is still not applicable as decrees are not yet implemented.
