MDStudy object

Investigation of MD - Definition

No specific French definition for studies with MD, only for observational studies with MD (Article R1121-2 CSP).

A definition for "Interventional clinical trials on a medical device (MD)" is provided in guidance document "Avis au promoters/ Notice to sponsors" available on ANSM website as follows:
'any clinical trial or clinical investigation of one or more medical devices aiming at determining or confirming their performances or highlighting their adverse effects and at evaluating if these constitute risks taking into consideration the performances imputed to the device.'