EU Moves Closer to Tightening its Medical Device Regulations

Lawmakers in the European Union passed stricter legislation for the regulatory approval and marketing of medical devices. Though the move didn’t go far enough for some, the medical device industry is breathing a sigh of relief.

The new rules still must be endorsed by the European Union’s 28 member states before they can become law. Parliamentary officials say that they hope to start talks with the member states within a few weeks, and to win their endorsement by May.

Critics of medical-device regulation in the European Union—long seen as weaker or less strict than the U.S. Food and Drug Administration’s (FDA) process in the United States—welcomed the move, but some said the new rules don’t go far enough to ensure the safety of medical devices, which range from less-complex technology such as syringes to higher-risk devices such as implantable orthopedic devices and heart valves.

The vote follows a pair of medical-device scandals that have prompted calls for tougher device regulation in the United States and Europe. Starting in 2010, thousands of women in Europe and other countries have had their breast implants removed after it emerged that the now-defunct French company Poly Implant Prothèse, or PIP, made the implants with substandard silicone gel that caused the product to rupture and leak in the body. The implants—used both for cosmetic purposes and in breast-cancer patients—were never marketed in the U.S.

Also in 2010, British data showed that metal-on-metal hips deteriorated and required replacement at unusually high rates. DePuy, the orthopedic arm of device giant Johnson & Johnson, one of the makers of the metal implants received by roughly 93,000 patients worldwide, issued a global recall of the devices in 2010 and said it would cover the cost of all medical care associated with the implants, including replacement surgery.

“We talk about products which are supposed to help patients in their suffering, in their illness… We need a better system,” said Dagmar Roth-Behrendt, a member of the European Parliament who drafted the legislation, told the Wall Street Journal.

The document creates stiffer rules for the regulatory bodies that consider new devices for approval. Unlike in the United States, where a central regulatory body—the FDA—considers medical devices for clearance or approval through a few different routes ranging from less-stringent 510(k)s to clinical trial-backed premarket approvals, Europe’s system gives that responsibility to private companies known as notified bodies, which are paid by medical device manufacturers to carry out their reviews.

In the past, notified bodies sometimes would hire subcontractors to carry out the assessment of devices. The new rules would require these bodies to have in-house experts to carry out the work. The legislation also limits the number of notified bodies allowed to handle review of implantable devices, and requires them to be supervised by the European Medicines Agency, the regulator that oversees pharmaceutical safety.

The new rules would allow for unannounced inspections of device makers, and would require every patient receiving an implant to be registered in a central database, so they could be contacted quickly in case of a problem. During the PIP scandal, officials had difficulty tracking patients who had received the breast implants.

Carl Heneghan, a physician and professor of evidence-based medicine at Oxford University, called the rules a “step forward” but criticized officials for leaving the review process in the hands of private firms that are paid by the medical device industry. This allows companies to “shop around” for the most compliant firm, he said. “If a company doesn’t get you approved, you’ll go elsewhere,” he told the Journal.

Europe, he said, should have one central, taxpayer-funded device regulator, like the FDA. Some members of the European Parliament also pushed for this but it didn’t garner enough support.

Officials of the European Confederation of Medical Device Associations (Eucomed) welcomed the vote’s outcome. “The parliament has voted for many improvements that will effectively improve patient safety,” said Eucomed CEO Serge Bernasconi. “We believe that this paves the way for further needed improvements to be discussed… We congratulate the parliament in finding more clarity and positive approaches in important areas supporting safety of patients and innovation for patients in what has been a very complex and highly technical dossier. We are looking forward to seeing continued evolution on a future strengthened EU framework for medical devices.”

Eucomed officials noted that, from their perspective, there was still work to be done—particularly in the area of medical device reprocessing. The group argues that reprocessors aren’t held to the same strict standards as device companies and that the proposed legislation needs “clarified” language in the area of reprocessing.