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Decree No. 96/32 of 15 January 1996 on Materiovigilance Exercised on Medical Devices and Motivating the Public Health Code (Second Part: Decrees in Council of State) Medical Equipment and Materiovigilance in the European Context.
http://www.sante.gouv.fr/IMG/pdf/referentiel_securite_sanitaire_2010.pdf

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