Intended for healthcare professionals


Europe’s plan to tighten regulation of devices will not reach US standards

BMJ 2012; 345 doi: (Published 19 September 2012) Cite this as: BMJ 2012;345:e6303
  1. Rebecca Coombes
  1. 1BMJ

Plans to tighten Europe’s regulation of medical devices in the wake of the recent breast implant scandal will not go as far as the stricter controls in operation in the United States, it emerged last week.

Instead, proposals to be put before the European parliament only partially tighten the regulatory grip on device manufacturers. The recent Poly Implant Prosthèse (PIP) scandal, when an estimated 40 000 UK women were given breast implants filled with non-medical grade silicone, exposed key weaknesses in the European system.1 By contrast, the implants were never approved for use in the US.

Jacqueline Minor, director for consumer policy at the European Commission, said, “The PIP scandal was very salutary for us. It was a fraud, quite deliberate criminality, which you can never …

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