Section 1: Scope of application.

The provisions of this Title apply to in vitro diagnostic medical devices as defined in Article L. 5221-1.

Where an in vitro diagnostic medical device forms an inseparable unit with a device which, if used separately, could be considered to be a medical device within the meaning of Article L. 5211-1 and whose action is ancillary to that of the in vitro diagnostic medical device, the latter is governed by the provisions of this Title, without prejudice to the application of the provisions of Title I with regard…

The provisions of this Title do not apply to: 1° Instruments, apparatus, equipment, materials or other articles, including software, intended to be used for research purposes without pursuing medical objectives ; 2° Reference materials certified at international level and materials used in programmes for the external assessment of the quality of analyses carried out by medical laboratories, with the exception of calibration agents and control materials which enable the user…