Article R5211-51 of the French Public Health Code
November 1, 2023
As part of the procedure applicable to custom-made medical devices, the manufacturer must draw up documentation including the name and address of the manufacturer, the place or places of manufacture, information enabling the device concerned, the prescriber of this device and, where applicable, the care establishment concerned to be identified, as well as the characteristics indicated in the medical prescription. This documentation also includes a statement indicating that the device…
