Report: European Commission must speed up tougher medical implant regs
At the current rate, the European Commission won't finish beefing up regulations designed to better protect medical implant patients from harm for at least two more years. That's not good enough, a parliamentary committee report concludes, urging commissioners to move faster before more patients are placed at risk.
The Science and Technology Select Committee wants the EC to speed up its process in implementing crucial changes, BBC News reports, with the belief that notified bodies that grant CE mark status under the current system likely vary greatly in quality.
With this in mind, committee members want the EC to make sure that the regulatory system can better track an implant's country of origin, whether other regulatory bodies have previously rejected the implant and a public record that tracks each time a manufacturer seeks approval from a notified body. Additionally, the report's authors want doctors mandated to report any faulty medical devices they deal with directly.
"I think in the interests of patients we would get a better system in place if the commission speeded up the process," Committee Chairman Andrew Miller told BBC News.
The report taking EC slowness to task follows a recent U.K. newspaper sting that accused notified bodies of competing for business and offering regulatory advice on how to package an all-metal hip implant made elsewhere as locally manufactured. And Europe is still reeling from the aftermath of a scandal regarding the now-defunct French breast implant maker Poly Implant Prothese (PIP). Regulators recommended their removal after reports surfaced that the implants ruptured more easily than standard ones, and the company's then-CEO Jean-Claude Mas admitted last year that the company used unapproved silicone in its products. A judge recently released Mas from jail, pending a trial next year.
- here's the BBC News story