Section 1: Scope of application.

The provisions of this Title apply to the medical devices defined in Article L. 5211-1. These devices are intended to be used for the purposes of: 1° the diagnosis, prevention, control, treatment or alleviation of a disease ; 2° The diagnosis, monitoring, treatment, alleviation or compensation of an injury or disability; 3° the study, replacement or modification of anatomy or a physiological process; 4° Design control.

Medical devices intended for the administration of a medicinal product are governed by this Title. However, where a device forms with a medicinal product an integrated product intended exclusively for use in the given combination and which is not reusable, this product is governed by the provisions applicable to medicinal products. The device must comply with the essential requirements concerning the safety and performance of medical devices referred to in…

The provisions of this Title do not apply to: 1° in vitro diagnostic medical devices ; 2° Products which, because of their principal mode of action, are considered to be medicinal products; 3° Cosmetic products; 4° Human blood, blood products, blood cells of human origin or devices containing labile blood products or cells of human origin when they are placed on the market; 5° Organs, tissues or cells of human…