MASSDEVICE ON CALL — Medical device makers and European regulators appear to be at an impasse over new regulations proposed in the wake of the breast implant recall that revealed shortcoming in the E.U.
The European Parliament is poised to host a public debate today to hash out the details of a new medtech regulatory system that incorporates some elements that are reminiscent of the device oversight in the U.S.
Medical device groups were quick to criticize the European Commission’s medical device regulatory guidelines when they were released late last year, saying certain updates stall innovation rather than bolster safety.
European medtech lobby Eucomed reiterated some of those sentiments in a statement issued this week.
"Many groups and experts in Europe, including doctors, patients and manufacturers, agree that the current decentralized European system needs to be improved to avoid incidents from happening as well as being able to cope with new medical technologies," Eucomed CEO Serge Bernasconi said in prepared remarks. "
There are different schools of thought on how to improve the system and one of them is to radically change the current system to a centralized pre-market approval structure. Research has proven that this will not lead to increased safety but results in an unnecessarily delay of 3-5 years of lifesaving medical devices reaching patients in Europe."
European authorities have been assessing medtech review standards, which haven’t changed much in 2 decades, since the European Commission in 2008 identified several vulnerabilities. Regulators came under intense pressure to revise security standards for medical devices after a wide-scale breast implant recall dramatically exposed weaknesses in the system.
The PIP implants evaded notice despite inspections at manufacturing facilities because the company was given 10 days notice prior to the checks and workers concealed the problem silicone, according to reports.
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