Design History File (DHF) - Fichier Historique de Conception
compilation of records which describes the design history of a finished device.
Device History Record (DHR) - Dossier Historique du Dispositif
compilation of records containing the production history of a finished device.
Device Master Record (DMR) - Dossier Principal du Dispositif
compilation of records containing the procedures and specifications for a finished device.
Medical Device Reporting (MDR) - Rapports sur les instruments et dispositifs médicaux
https://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm
specified by 21 CFR part 803
MDR is the mechanism for the FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly