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Master Thesis

La traçabilité sanitaire des dispositifs médicaux implantables : encadrement juridique et institutionnel

Abstract : Implantable Medical Devices (IMD) are health products meant to remain in contact with the human body for an extended period of time and thus a potential health risk. Therefore, they are subject to specific traceability rules. Sanitary traceability is part of materials vigilance and aims to allow the rapid identification of patients for whom the IMD of a batch have been used or the batches from which the IMD used for a patient come. It was absent from the first European directives relating to medical devices (MD) but has been regulated by French legislation since 2006. The European Regulation 2017/745 will come into force on May, 2017 and one of its objectives is to reinforce the vigilance and traceability procedures for IMD with the introduction of a unique device identification (UDI) and a European database on medical devices: Eudamed. This regulation will set new rules to all MD sector players, including health structures and professionals. These actors are supported nationally by various public health institutions and agencies. The French Ministry of Solidarity and Health will be able to make the legislative and regulatory framework relating to health traceability evolve in relation to the services which back its action throughout the country. The National Agency for the Safety of Medicines and Health Products is the French government agency with jurisdiction over MD and can rely on many institutional actors operating at the national and regional level. This framework allows the effective implementation of sanitary traceability and the proper functioning of the materials vigilance system in France.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-03044051
Contributor : Ufr Santé Unicaen <>
Submitted on : Monday, December 7, 2020 - 4:21:55 PM
Last modification on : Friday, December 18, 2020 - 3:36:40 AM

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  • HAL Id : dumas-03044051, version 1

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Guillaume Descotes. La traçabilité sanitaire des dispositifs médicaux implantables : encadrement juridique et institutionnel. Sciences pharmaceutiques. 2020. ⟨dumas-03044051⟩

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