Authors:
Candice Houg
1
;
2
;
Thomas Lihoreau
1
;
2
;
Martina Hennessy
3
;
Helene Esperou
4
;
Rachel Benamore
5
;
Jean Palussiere
6
and
Lionel Pazart
1
;
2
Affiliations:
1
Centre Hospitalier Universitaire de Besançon, Centre d'Investigation Clinique, INSERM CIC 1431, 25030, Besançon, France
;
2
Tech4Health network - FCRIN, France
;
3
Wellcome-HRB Clinical Research Facility, St James’s Hospital and School of Medicine Trinity College Dublin, Dublin, Ireland
;
4
Clinical Research Unit, National Institute of Health and Medical Research, Paris, France
;
5
Department of Radiology, Oxford University Hospital Trust, Oxford, U.K.
;
6
Department of Interventional Radiology, Bergonie Institute, Bordeaux, France
Keyword(s):
Clinical Investigation, Regulatory Approach, Medical Device, CE Marking, European Medical Device Regulation 2017/745, Brexit, Ethics Committee, Competent Authority, High-risk Device.
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.