Authors:
Vaissière Anaïs
1
and
Chevallier Thierry
2
;
3
;
4
Affiliations:
1
Regentis-Pharma, 8B Rue Gabriel Voisin, Reims, France
;
2
Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology (BESPIM), CHU Nîmes, Place du Pr. Robert Debré, 30029 Nîmes, France
;
3
Tech4Health-FCRIN, France
;
4
UMR 1302, Institute Desbrest of Epidemiology and Public Health, INSERM, Univ. Montpellier, Montpellier, France
Keyword(s):
Medical Devices (MD), Combined Medical Devices, Combined Dressings, Cutaneous Healing, Ancillary Substance, Peptide, Health Authorities, Classification, European Regulation 2017/746.
Abstract:
Skin healing is a rapidly expanding field, especially with the growing needs of an aging population and the increase in chronic pathologies (diabetes, venous ulcers, bedsores etc...). In order to offer ever more adapted solutions, manufacturers are competing in ingenuity to propose innovative medical devices that meet the expectations of patients, caregivers and the healthcare system. These developments raise many questions, particularly with regard to the classification of devices in the various risk classes and the naming of these wound healing devices. This article will focus on combined medical devices with the difficulties they pose for manufacturers and health authorities in terms of development, financial investment, risk-taking and the difficulty of classifying these so-called borderline products in the medical device universe.