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Règles applicables aux essais cliniques portant sur les dispositifs médicaux |
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| Authors: | F Claudot C Pasquier F Alla H Coudane J Felblinger |
| Institution: | 1. Service de médecine légale et droit de la santé, faculté de médecine, université de Nancy, 54035 Nancy cedex, France;2. Affaires juridiques, direction générale, centre hospitalier universitaire de Nancy, 54035 Nancy cedex, France;3. Centre d’investigation clinique – Épidémiologie clinique, centre hospitalier universitaire de Nancy, 54035 Nancy cedex, France |
| Abstract: | It is sometimes not easy to navigate in the meanders of the national regulation dealing with medical devices. This article intends to present the ethical framework as well as the practical methods of application of the French regulation for clinical trials in this field. In particular, we review the major steps and the key sensitive elements concerning the protection of the people and the protection of collected data. |
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