Medical devices panorama in France
By lscconsultingfr
The Medical Devices Panorama Day, organized by SNITEM, was held at the Cité des sciences et de l’industrie – Paris. It was divided into 4 parts: a numerical overview of the DM sector in France, a retrospective analysis of the Covid crisis and its impact on the market, a summary of the sector’s development issues and a prospective assessment.
Following the Covid crisis, the number of MD companies presenting on the market has decreased: 126 companies have left the market and 63 have entered it, leading to a negative balance and bringing the number of players down to 1,440, a drop of 4.5% (1,502 companies in 2019).
This disruption results in a change in the medical device landscape. The new entrants are 32% start-ups positioned on e-health MDs, 28% on equipment MDs, 22% on single-use MDs and 18% on IVD manufacturing.
The new regulation (applicable since May 2021) leads to a significant increase in the requirements expected from the manufacturer for CE marking. In order to accelerate access to innovative devices, two derogatory procedures have been put in place:
- The innovation package: this consists of early and derogatory coverage of medical devices and innovative procedures, in condition of the completion of clinical and possibly medico-economic studies to provide the missing data.
- The early access system: Resulting from the law on the financing of social security for 2020 and translated by the decree of February 23, 2021, the system of responsibility assumption allows the marketing of a CE marked medical device, at the end of the studies, for a period of one year (renewable once)
Regarding the recruitment in the field of MD industry. There is a strong tension on human resources, mainly talents specialized in regulatory affairs, which are strongly solicited after the new regulation. This raises recruitment difficulties.
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