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Eucomed opposes additional approval process for European medical device directive
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Eucomed has cautioned against implementing scrutiny procedures outlined in the proposed European Medical Device Directive, noting these procedures will harm patients, European governments and industry.
While most measures – such as more control of manufacturers and companies acting on behalf of governments to assess medical device safety for patients, establishment of a registry database for devices and “increased coordination and vigilance” – were well-received by Eucomed, other proposals, like a scrutiny procedure that would create a “centralized premarket authorization system” similar to the FDA in the United States, are opposed on grounds of hampering innovation, harming patients and small businesses looking to break into the industry, according to a Eucomed press release.
“I urge all decision makers who want to make fundamental changes to the European system for medical devices to tread with caution,” Guy Lebeau, MD, Eucomed chairman, stated in a press release. “European patients and European medical research and innovation have benefitted heavily from a system that is the world’s fastest in providing patients with life-saving technologies while not compromising safety. I fully agree that changes need to be made to the current regulatory framework, but let us make sure we keep the best system for patients and medical progress in Europe.”
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