Information for distributors of dental implants: intended use, responsibility, surveillance
The 93/42EEC Directive on medical devices is the official reference that dictates the regulations for marketing medical devices. The directive provides indications for all the phases of existence for the device (from the project phase through the traceability system, and surveillance), and it identifies all the characters who have to comply with the directive itself, which includes not only the manufactures, but also the distributors, the buyers, and even the users. As for the responsibilities of the single competence, Leone S.p.A. recommends to its direct clients, dental depots and exclusive dealers to follow and maintain the indications, warnings, and information for the univocal identification of the medical devices, as provided by the manufacturer on the labels, during all the marketing phases. With specific regard to Class IIB implantable products, all dental depots and exclusive dealers of Leone S.p.A. are required to keep records of the distribution of medical devices as of traceability available for verification, in case of need to trace back a product or its user in a univocal way.