Article R5212-33 of the French Public Health Code
If the quality control has led to the reporting of a risk of incident as provided for in Article R. 5212-31, the operator shall notify the Director General of the Agence nationale de sécurité du médicament et des produits de santé and the Director General of the regional health agency within whose jurisdiction the operator is established, of the medical device’s return to compliance or its definitive withdrawal from service….