A sector that is not immune to controversy: we remember in the early 2010s the scandal of defective breast implants PIP, marketed by the entrepreneur Jean-Claude Mas. In the process, the German certification body for these prostheses, TÜV, had been ordered in France to compensate thousands of complainants.
“The case of the PIP implants has revealed a difficulty in applying certain rules by the notified bodies” responsible for certifying the products, recognizes Cécile Vaugelade, director of technical and regulatory affairs at Snitem, the professional union in the sector.
25,000 certificates to be issued
To bring order, the European Commission adopted in 2017 a regulation aimed at “establishing a rigorous regulatory framework” for medical devices, “which guarantees a high level of safety and health protection while promoting innovation. “. This regulation has been applicable since May 26, 2021, with however a grace period until May 2024. But for the producers of devices, even thus extended, the deadline is too short.
Indeed, all medical devices already on the market must be certified again. However, there are some 500,000 devices on the market, covered by 25,000 certificates, explains Snitem, which is requesting a postponement of the grace period by two years for the devices in the highest risk class, and by four years for the others. . “Of the 25,000 certificates, only a thousand have been recertified so far,” insists Ms. Vaugelade.
To complicate matters, the bodies responsible for examining the devices must be recertified under this new regulation. A long and complex process, which means that currently, 27 organizations have been authorized in the European Union, compared to twice before. In France, only one organization, GMED, received the precious sesame.
Possible market withdrawals
With the risk of products being withdrawn from the market, alerts the sector. Concerns heard by the French health authorities.
“At the national level, France accompanied, at the same time as the designation of the notified body GMED, an increase in its workforce to increase its processing capacity for French VSEs and SMEs”, indicates the General Directorate of Health in an email to AFP. The authority also specifies that the government has “mobilized public funds” to set up a support counter for VSEs and SMEs in their procedures.
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