- Journal
- Année
- 2021
- Pages
- 250-258
- DOI
- 10.5220/0010968600003123
Abstract
The evolution of technological innovations and medical devices requires particular reflections in terms of regulation. In order to harmonise practices between European countries and to reinforce clinical investigations, the European Regulation on medical devices 2017/745 has come to give a regulatory framework to the world of devices. A summary of the regulatory approaches for a clinical investigation of a new class III device conducted in France, Ireland and England is proposed in this article to illustrate the complexity of the processes, ending with an example. This illustrates the impact of the EU regulation and Brexit on the conduct of clinical investigations.