Section 1: Definitions.

I. – For the purposes of this Title, research involving the human person means research organised and carried out on healthy or sick volunteers, with a view to developing biological or medical knowledge and aimed at evaluating : 1° the functioning mechanisms of the human organism, whether normal or pathological ; 2° The efficacy and safety of the performance of procedures or the use or administration of products with a…

Research involving the human person relating to a medicinal product is understood to mean any research relating to one or more medicinal products not falling within the scope of Article 1 of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/ EC. They are intended to identify or verify the…

The research referred to in 3° of Article L. 1121-1 involving products referred to in Article L. 5311-1 is understood to mean any research in the context of which the product or products are prescribed or used on a regular basis and which complies with : 1° For research involving medical devices and in vitro diagnostic medical devices, with the intended use in the context of CE marking as mentioned,…