Authors:
L. Pazart
1
;
2
;
S. Pelayo
1
;
3
;
T. Chevallier
4
;
1
;
G. Gruionu
5
;
6
;
P. Mabo
1
;
7
;
Y. Bayon
8
;
F. Barbot
9
;
1
;
T. Lihoreau
1
;
2
;
C. Roussel
10
;
1
;
N. Maglaveras
11
;
E. Lekka
11
;
H. A. Ferreira
12
;
I. Rocha
13
;
L. Geris
14
and
C. Lavet
1
Affiliations:
1
Inserm, Tech4Health, FCRIN F-31000 Toulouse, France
;
2
Univ. Franche-Comté, Inserm CIC1431, CHU Besançon, F-25000 Besançon, France
;
3
Univ. Lille, Inserm, CHU Lille, ULR 2694, METRICS, F-59000 Lille, France
;
4
IDIL- Nimes University Hospital and INSERM IDESP, F-30000, Nimes, France
;
5
INCESA Institute, Faculty of Mechanics, University of Craiova, Craiova 200512, Romania
;
6
Krannert Institute of Cardiology, Indiana University School of Medicine, Indianapolis, IN 46202, U.S.A.
;
7
Univ. Rennes, CHU de Rennes, Rennes, France
;
8
Medtronic, Sofradim Production, Trévoux, France
;
9
CIC 1429 Inserm, Hôpital Raymond Poincaré APHP, Garches, France
;
10
CIC 1415, CHU Tours, Inserm, University of Tours, France
;
11
Lab of Medical Informatics, Aristotle University of Thessaloniki, Thessaloniki, Greece
;
12
Instituto de Biofísica e Engenharia Biomédica, Faculdade de Ciências da Universidade de Lisboa, Portugal
;
13
Lisbon School of Medicine & Cardiovascular Centre, Universidade de Lisboa, Lisboa, Portugal
;
14
Biomechanics Research Unit, GIGA In Silico Medicine, University of Liège, Belgium
Keyword(s):
High-risk Medical Device, Medical Device Regulation, Clinical Investigation, EU MDR 2017/745, Regulatory Science.
Abstract:
This position paper analyses the threats from the current situation of the clinical investigation to the expectations of the new European regulations focusing on high risk medical devices (HRMDs). We present also some opportunities to improve the feasibility and quality of clinical investigation. In summary, investigation protocols of medical devices, advised and authorized by the competent authorities, are few and heterogenous. There is a lack of quality in the existing studies, a lack of methodological knowledge and consequently high expectations for assistance from those involved in the design of clinical study protocols on HRMD. Guidance that is specific to the different type of devices is missing. Adaptive designs, pragmatic trial, usability methods, computer modeling and real world data are gaining more and more traction for assessing the safety and performance of high risk medical devices from a regulatory view-point.