Résumé
In vitro diagnostic medical devices are health products aimed at diagnosis. They have an important role to play in the patient care pathway. Their free movement on European market requires to demonstrate their conformity to essential requirements described in the regulation in order to obtain a CE marking.Following various health scandals and due to limits and weaknesses of directive 98/79/EC that regulates in vitro diagnostic medical devices in Europe, the regulation has been reviewed with a new text: Regulation (EU) 2017/746. The objective being to ensure a better regulatory harmonization among Europe and a better quality and security level for the patients.Currently in a period of regulatory transition; adapt to the changes represent a real challenge for the sector actors and in particular the legal manufacturers.The objective of this thesis is to present the issues and the impact of the changes bring by the Regulation (EU) 2017/746 for the in vitro diagnostic medical devices’ legal manufacturers. For that we will begin with a presentation of the sector by returning on the notion of in vitro diagnostic medical device, the market represented by these health products, the actors that participate to launch these products on the European market, the regulatory context, the CE marking. Next, I will briefly return on my experience and evolution within this sector. Then we will develop the changes bring by this new regulation and we will end by presenting the difficulties meet by the legal manufacturers and the solutions allowing to help them.