Report: French commission calls for massive medtech regulation overhaul

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 bod...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Regulatory/Compliance European Medicines Agency (EMA) Source Type: news