Authors:
Marina Makeenko
1
and
Thierry Chevallier
2
;
3
;
4
Affiliations:
1
Biotechni SAS, 178 Avenue du Serpolet, La Ciotat, 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 Device, Post-market Clinical Follow-up, PMCF, GAP Analysis, Legacy Devices.
Abstract:
The passage from the MDD 93/42/CEE to the MDR 2017/745 remains a big challenge for the manufactures. The interpretation of the regulatory requirements stays unclear and can differ from one source to another, especially when it comes to the clinical evaluation. Will the data collected under the MDD 93/42/CEE be sufficient to prove the safety and security of the device? Under the directive each country was establishing its own requirements for the conduct of the studies. The MDR has standardized these rules, so that all the clinical data collections follow the same pathway. We will examine the PMCF of the class III devices already CE marked under the directive (legacy devices) to find out if the new requirements will be asked to be in compliance with the MDR. A Gap analysis between the MDD and MDR will help us in our research. A matrix in the form of a questionnaire will be established to help us verify compliance of the PMCF under the MDR.