Subsection 1: General provisions

I. – The biovigilance system covers : 1° Elements and products of the human body and their derivatives used for therapeutic purposes as well as medical devices incorporating them; 2° Activities relating to these elements, products or derivatives as implemented by the persons mentioned in article R. 1211-32; 3° Donors of elements or products of the human body, patients and recipients who have recourse to grafting or the administration of…

The purpose of biovigilance is to : 1° Systematically monitor all incidents and adverse reactions; 2° Immediately report serious incidents and unexpected adverse reactions to the local biovigilance correspondent; 3° Immediately report serious incidents and unexpected adverse reactions to the Agence de la biomédecine; 4° Analyse, evaluate and use this information to limit the probability of occurrence of any new serious incident or unexpected adverse reaction or to reduce their…

For the purposes of this section, the following definitions apply 1° Incident: an accident or error related to activities involving the elements, products or derivatives mentioned in 1° of the I of article R. 1211-29, resulting or likely to result in: a) an adverse reaction in the persons mentioned in 3° of the I of article R. 1211-29; b) A loss of the element, product or derivative; c) A quality…