Authors:
Marion Burland
1
and
Thierry Chevallier
2
;
3
;
4
Affiliations:
1
Department of Quality, Regulatory and Clinical Affairs, DEDIENNE Santé, Le Mas des Cavaliers, 217 rue Charles Nungesser, 34130 Mauguio, 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):
Massive Database, Real Life Study, Post-Market Clinical Follow up, Medical Device.
Abstract:
With the application of new European regulations on medical devices in May 2021, the requirements for clinical evaluation have been strongly reinforced. Post-marketing clinical follow-up is now a key activity for manufacturers to keep their medical devices on the market. The use of material-epidemiology studies and real-life databases has multiple strengths and advantages. However, the weaknesses and limitations identified do not yet allow manufacturers (especially small and medium-sized companies) to fully utilize these tools for post-market clinical follow-up. Yet certain technological and regulatory developments already implemented, and to be implemented over time, suggest that these tools could play a crucial role in the clinical monitoring of medical devices in the future. In order to better define the future use of real-life data in post-market clinical follow-up activities, a comprehensive update of technological and regulatory surveillance is still required.