MEPs vote for stricter rules on medical devices

23 Oct 2013 | News
Faulty hip and breast implant scandals prompt stricter monitoring and certification for new devices
By Joanne O'Dea
The European Parliament approved stricter legislation for the approval and marketing of medical devices ranging from syringes to pacemakers, including plans to set up a central register to enable recipients to be tracked if there are any problems with an implanted device.

The new rules will apply across each of the EU’s 28 member states, a change from the existing patchwork of legislation, said rapporteur Dagmar Roth-Behrendt. "We don't have unified standards in the EU. Every doctor in the EU can do pretty much what they want, with different conditions, different criteria, different terms," she said.                                                                                             

The parliament will now negotiate legislation with member states, with MEPs saying the controls could be in place next year.

Devices to be assessed by experts

The proposal will give member states more control over the organisations that consider new devices for approval. Unlike the US, where a central body approves medical devices for the market, private companies, called "notified bodies", have responsibility in Europe. These companies sometimes rely on subcontractors to examine products, a practice that will be eliminated under the new rules, which state that assessment groups must have a permanent team of in-house qualified experts to carry out the work. 

A new group of experts, designated by the European Medicines Agency – the regulatory body that oversees pharmaceutical safety - will assess “high risk” devices for use inside the human body. 

"Patient safety will be substantially improved,” said Roth-Behrendt. "In the recent past, too many dangerous medical devices such as hip implants have been introduced into the bodies of thousands of patients in Europe." 

But Monique Goyens, Director General of The European Consumer Organisation (BEUC), said pre-market testing needs to be even stricter, “There will still be no thorough evaluation of the risks and benefits of a device before it is used. Under the current system, consumers will continue to be used as guinea pigs.”


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