A French parliamentary body is calling for a significant overhaul of medical device regulations in the country and across Europe, calling the existing system “massively dysfunctional,” according to a new report from the International Consortium of Investigative Journalists’ Implant Files.
A French Specially Convened Commission on Medical Devices, composed of parliamentarians Julein Borowczyk and Pierre Dharréville, recently endorsed a 97-page report advocating for 36 separate reforms, according to the report.
Endorsed reforms include the creation of a centralized European agency in control of approving high-risk devices and establishing a laboratory to investigate extracted implants, as many are removed after a failure, the ICIJ reports.
The commissioners suggested strengthening existing European regulations for vetting devices before approval, and reinforcing national oversight measures for approved devices, according to the report.
The pair of parliamentarians criticized European medical device regulation over potential conflicts of interest for device approvals, as clearance in the region relies on private Notified Bodies which are paid for by device manufacturers, according to the report.
The report also suggested that the system is not robust enough to resist the influence of profit-driven device manufacturers looking to hastily push their products to market at the cost of reduced testing and studies.
“The essential place entrusted to these audit bodies … has led to a complete bankruptcy of the health control system for placing [devices] on the market,” the report states, according to the ICIJ. “This balance between the manufacturer’s … impulse and the ability of the regulatory to counter it, where it poses health safety risks, is probably at the root of the now well-known failures of the control system.”
The commission suggested moving high-risk device control and regulation to a new department with the European Medicines Agency that would see similar oversight to the EMA’s regulation of drugs, according to the report.
The report is not the first time a single regulatory body has been suggested to oversee device regulation in the EU, ICIJ reports. Past attempts to create such a regulatory body have been strenuously opposed by industry lobbyists who went as far as using misleading claims to defeat the proposal.
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