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Article R5211-11 of the French Public Health Code

In the event of a dispute over the application of the classification rules between the manufacturer of a device and an authorised body involved in the certification procedures provided for in this Title, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall determine the class to which the device in question belongs.

Original in French 🇫🇷
Article R5211-11

En cas de litige sur l’application des règles de classification entre le fabricant d’un dispositif et un organisme habilité intervenant dans les procédures de certification prévues au présent titre, le directeur général de l’Agence nationale de sécurité du médicament et des produits de santé détermine la classe dont relève le dispositif en cause.

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