French Public Health Code
In forceFor the research referred to in 1° of Article L. 1121-1 concerning medical devices and in vitro diagnostic medical devices, the sponsor must report to the Agence nationale de sécurité du médicament et des produits de santé any suspected serious unexpected adverse reaction and any serious adverse event that may be related to the procedure for using the medical device that occurs in France and outside national territory:
1° In the case of a serious unexpected adverse reaction and a serious adverse event which may be related to the procedure for implementing the medical device and which has resulted in death or has endangered life, without delay from the day on which the sponsor becomes aware of it.
2° In the case of other unexpected serious adverse reactions and other serious adverse events which may be related to the procedure for implementing the medical device, no later than fifteen days from the day on which the sponsor became aware of them.
In the case of an unexpected serious adverse reaction or a serious adverse event which may be related to the procedure for implementing the medical device and which has resulted in death or which is life-threatening, the relevant additional information shall be notified within eight days of the deadline mentioned in 1°.
In the other cases of unexpected serious adverse reactions and serious adverse events which may be linked to the action of implementing the medical device, as well as the new facts mentioned in Article L. 1123-10, the relevant additional information is sent to the Agence nationale de sécurité du médicament et des produits de santé and, where applicable, to the relevant personal data protection committee within a further fifteen days of the fifteen-day period mentioned in 2°.
