Chapter II: Vigilance measures.

The natural or legal person responsible for the sale, whether for consideration or free of charge, of a second-hand device included on a list drawn up by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products), must draw up, in accordance with the procedures laid down by decree in the…

The obligations of notification to the National Agency for the Safety of Medicines and Health Products or of information incumbent, under the vigilance exercised over the devices mentioned in Article 1 of Regulation (EU) 2017/746, on the manufacturer or, where applicable, his authorised representative, the importer and the distributor, are defined by this Regulation, in particular in Articles 10, 13, 14, 82, 83 and 84. In addition, any healthcare professional…

A decree in the Council of State shall specify the procedures for implementing the rules applicable to vigilance exercised over the devices mentioned in Article 1 of Regulation (EU) 2017/746, as well as the organisational procedures of the authorities and bodies concerned.