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Article R5222-11 of the French Public Health Code

All manufacturers of in vitro diagnostic medical devices, or their representatives, shall appoint a person to be responsible for reactovigilance, whose identity and position shall be communicated to the Director General of the Agence nationale de sécurité du médicament et des produits de santé.

Original in French 🇫🇷
Article R5222-11

Tout fabricant de dispositifs médicaux de diagnostic in vitro, ou son mandataire, désigne une personne en charge de la réactovigilance, dont l’identité et la qualité sont communiquées au directeur général de l’Agence nationale de sécurité du médicament et des produits de santé.

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