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Article R5211-26 of the French Public Health Code

The manufacturer or his authorised representative shall, for a period of at least five years and, in the case of implantable devices, at least fifteen years after the last copy of the product has been manufactured, keep at the disposal of the Director General of the Agence nationale de sécurité du médicament et des produits de santé the declarations of conformity and technical documentation which he has drawn up as part of the procedures provided for in this section, together with the decisions and reports of the authorised bodies which have taken part in these procedures.

Original in French 🇫🇷
Article R5211-26

Le fabricant ou son mandataire tient à la disposition du directeur général de l’Agence nationale de sécurité du médicament et des produits de santé pendant une période d’au moins cinq ans et, dans le cas des dispositifs implantables, d’au moins quinze ans, après la fabrication du dernier exemplaire du produit, les déclarations de conformité et les documentations techniques qu’il a établies dans le cadre des procédures prévues par la présente section ainsi que les décisions et rapports des organismes habilités ayant participé à ces procédures.

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