Subsection 1: General provisions

I. – The vigilance system for medically assisted procreation concerns : 1° Gametes, germinal tissue and embryos used for the purposes of medically assisted procreation and the restoration of hormonal function ; 2° Activities relating to these gametes, germ tissue and embryos as implemented by the persons mentioned in Article L. 2142-1 ; 3° Persons who have recourse to medically assisted procreation or are the result of such assistance, gamete…

The purpose of vigilance in medically assisted procreation is to : 1° Systematically monitor all incidents and undesirable effects; 2° Report serious incidents and unexpected undesirable effects to the local correspondent without delay; 3° Report serious incidents and unexpected undesirable effects to the Agence de la biomédecine without delay after they have been reported; 4° Analyse, evaluate and use this information in order to limit the probability of occurrence of…

For the purposes of this section, the following definitions shall apply 1° Incident: an accident or error related to activities involving gametes, germinal tissue or embryos mentioned in 1° of the I of article R. 2142-39, resulting in or likely to result in: a) An adverse reaction in the persons mentioned in 3° of the I of article R. 2142-39 ; b) A loss of these gametes, germinal tissues or…