Subsection 3: Local monitoring system for medically assisted procreation

The establishments and organisations mentioned in 2° of article R. 2142-42 organise the implementation of the local system of vigilance in medically assisted procreation, in particular by making available to professionals the tools necessary to implement their missions of monitoring, reporting or declaring incidents and adverse effects. The Agence de la biomédecine offers methodological tools for this purpose. The local monitoring system for medically assisted procreation sets out the procedures…

I.-The establishments and organisations mentioned in 2° of Article R. 2142-42 shall appoint a local correspondent and his/her alternate. As soon as they are appointed, the identity, status, experience and contact details of the local correspondent and his/her alternate are communicated to the Agence de la biomédecine by the head of the structure in which the correspondent and his/her alternate perform their duties. The provisions of this decree also apply…

The local correspondent for the vigilance system relating to medically assisted procreation is responsible for : 1° Ensuring that the health professionals involved in the activities mentioned in 2° of I of Article R. 2142-39; 2° Gathering, keeping and making accessible the information communicated to it relating to incidents and undesirable effects; 3° Identifying and declaring serious incidents and unexpected undesirable effects to the Agence de la biomédecine without delay;…

Each establishment or body mentioned in 2° of Article R. 2142-42 shall ensure that a procedure is put in place to prevent the use of gametes, germinal tissue or embryos mentioned in 1° of I of Article R. 2142-39 that are likely to present a quality or safety defect.

Without prejudice to the obligation mentioned in Article L. 1413-14: 1° Any healthcare professional practising in a facility with a local correspondent for the vigilance system relating to medically assisted procreation and who is aware of the occurrence of any serious incident or unexpected adverse reaction must report it to this correspondent without delay. If the local correspondent or his/her deputy is unable to act, the healthcare professional must report…