Tighter Controls Urged for European Medical Devices

Medical devices, household appliances and toys currently are treated as equals by European regulators. An artificial heart valve, for instance, is given no more scrutiny than an electric toaster or, say, a soft, cuddly teddy bear. Cardiac stents, artificial joints and breast implants need only a CE Mark to be sold on the continent—the same approval world-renowned toymaker Mattell Inc. must get to sell its Matchbox cars.

Doctors have long criticized this practice, claiming the system allows potentially unsafe devices to bypass scrutiny and enter the market. Case in point: breast implants made by now-defunct French company Poly Implant Prothese (PIP). A dozen years ago, in June 2000, the U.S. Food and Drug Administration (FDA) posted a warning letter on the Internet about problems at the firm, claiming an inspection found some PIP products to be “adulterated.”

Nevertheless, the implants had been blessed by European regulators with CE Mark approval and thus, were available for sale in that market.

Two months ago, the French government advised 30,000 women to have their breast implants removed, warning the devices have an unusually high rupture rate and could contain industrial-grade silicone.

The controversy currently swirling around these implants only gives credence to the long-standing concerns of doctors and other clinicians over Europe’s medical device approval process. Most devices in Europe are regulated under the Conformite Europeenne, or CE Mark system, often referred to as the kite mark for its distinctive shape. The CE Mark is used to approve household items, children’s toys and mobile phones for sale. Naturally, the regulatory process is tougher for medical devices than it is for coffee makers or yo-yos, but approval for cardiac stents or an artificial hip component still can be obtained with relatively few tests. Medical devices most certainly have an easier regulatory approval path than pharmaceuticals, which generally are subject to extensive clinical trials.

The PIP implant controversy, however, is prompting European regulators to rethink the approval process for medical devices. The new chief executive at the European Medicines Agency (EMA), for example, believes that devices and pharmaceuticals should be treated the same, particularly in light of combination products such as drug-eluting cardiac stents. “I see an urgent need to regulate devices as the same level of science and attention as with drugs,” EMA Executive Director Guido Rasi told Reuters in a recent interview.

Based in London, England, the EMA only is mandated to regulate drugs. To assume responsibility for medical devices as well, the agency would need the blessing of politicians. “We are civil servants; we will do what we are told to do,” Rasi explained to Reuters.

New proposals from the European Commission on device approval, including measures for more pre-market testing and post-market surveillance, will be considered by European Union ministers later this year.

Overhauling the regulatory process, however, could be time consuming, especially since resistance exists from certain sectors of the device industry as well as some “national authorities.” “I don’t expect anything fast, but we need something for public health protection,” Rasi concluded.