Article R5221-23 of the French Public Health Code
November 1, 2023
As part of the procedure applicable to in vitro diagnostic medical devices undergoing an assessment of their performance, the manufacturer must draw up a declaration containing the data enabling the device and the assessment plan to be identified and certifying that the in vitro diagnostic medical devices comply with the provisions of this Title and the Orders made for its application which are applicable to them. The manufacturer undertakes to…
