Article R5461-4 of the French Public Health Code
November 1, 2023
The following constitutes a breach subject to a financial penalty: 1° For the manufacturer of a medical device or its authorised representative, failing to make available to the Director General of the Agence nationale de sécurité du médicament et des produits de santé the declarations of conformity and technical documentation drawn up as part of the certification procedures, as well as the decisions and reports of the authorised bodies that…
