Device makers, regulators butt heads over new E.U. regulations

Device makers, regulators butt heads over new E.U. regulations-massdevice: 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.