MASSDEVICE ON CALL — A clutch of European medical device makers lamented the European Parliament’s vote in favor of a new pre-market authorization system for medical devices that the med-tech makers say create "years of delay in the availability of medical technology solutions to European citizens."
The EP voted in favor of the new PMA process in light of a high-profile breast implant scandal regarding a recall of 30,000 sets of breast implants supplied by Poly Implant Prosthèse after regulators discovered that the company had been secretly filling the implants with non-authorized silicone.
European device trade group Eucomed acknowledged the need for greater safety measures for medical devices, but warned that the more lengthy PMA process would throttle medical innovation.
"Europe needs smart regulation that makes efficient and effective use of existing resources and involved structures (European Commission, Competent Authorities, Notified Bodies and industry) so as to retain a simple, adaptable and highly efficient system and merit public confidence," according to a press release. "Industry would be supportive of such a mechanisms provided it proves to enhance patient safety and would not slow down the approval process of medical devices. The latter point is critical in order to ensure timely patient access to innovative, efficient and cost-effective devices and for keeping innovation in Europe."
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