Civil liability of products - breast prostheses
French “Cour de cassation” 1st civil chamber, 10 October 2018 :
In a decision rendered on October 10, 2018 (1st Civil Chamber, no. 15-26.093), the French “Cour de Cassation” imposes an obligation of vigilance to notified authorities responsible for the certification of implantable medical devices (in the present case the manufactured breast implants).
The Highest Court states that if indices suggest that the devices are not consistent with the requirements of the Directive 93/42/EEC, during their monitoring mission of these devices, these authorities must take all the necessary measures and, in this case, check the documents identifying the raw materials or proceed with unscheduled visits to the manufacturer.
In the absence of such audits, the notified authority is liable on the basis of Article 1382 (now 1240) of the Civil Code.