Authors:
Catherine Roussel
1
;
Alexandrine Salis
2
and
Sylvia Pelayo
3
Affiliations:
1
INSERM CIC 1415, University Hospital, Tours, France
;
2
INSERM FCRIN UMS 015, University Hospital, Toulouse, France
;
3
Univ. Lille, INSERM, CHU Lille, CIC-IT 1403 - Centre d'Investigation Clinique, EA 2694, F-59000 Lille, France
Keyword(s):
High-risk Medical Device, Risk, Evaluation, CE Marking.
Abstract:
Medical Devices are health products that combine complex technologies and new organizations. They are under high constraints, both economic and regulatory, but also in terms of quality and safety requirements. The new European regulation comes in addition and questions all of the actors of the maturation process from the idea-to-market for medical devices (MDs). The objective of this qualitative study was to collect and analyze feedback from various European stakeholders involved in the clinical evaluation of medical devices, with a special focus on innovative high-risk medical devices. This paper presents the results of the first phase which scope was limited to France with sixteen interviews. Results show the complexity of the clinical evaluation of MD, particularly when dealing with an innovative, high-risk medical device. The need for training and support of actors through specialized platforms was highlighted, as well as the need for coordination between public and private actor
s, from the upstream phases of R&D. The collection of clinical data must be part of an overall strategy considering the maturation cycle of the product and its different dimensions. The collection of real-life data must be amplified and structured, with the contribution of new digital technologies opening up new fields of research. This approach must be strengthened by (i) the development of methods based on choices justification, and (ii) making it possible to capitalize on and cross-reference data on the Medical Device throughout its life span. The brief overview provides convergent conclusions, but the understanding of the required level for the evaluation of medical devices and of the way to reach it was not uniform. This reflects a heterogeneous sector and it introduces the need of compromises regarding development strategies and methodological approaches.
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