Will Europe's clampdown on faulty medical devices hurt patients?

BERLIN: When a Californian company founded by a U.S. veteran wounded in Afghanistan sought to register a new medical device this year, it turned to Europe before the United States. The European approvals system had long been quicker, the company said, but the introduction of new rules is changing all that.

“Now it has flipped,” said Bill Colone, CEO of San Clemente-based Spinal Singularity, which hopes to launch a ‘smart’ catheter for men with spinal injuries or disease early next year after squeezing in its application under the old European rules.

Colone is part of a chorus of industry voices warning that a switch to stricter European rules governing medical devices, due to come into force a year from now, will slow or even halt the release of products in Europe that could transform patients’ lives.

Defenders of the regulations say they will not significantly complicate the process and are vital to prevent problems like rupturing silicone breast implants and debris from all-metal hip implants damaging tissue and bones.

Many patient advocates say the new rules do not go far enough to reform a European system in which a top U.S. official suggested in 2011 patients may be “guinea pigs” here. The comment drew a sharp response from the European Union, which still firmly rejects that characterization.

That transatlantic spat, and the subsequent evolution of medical device certification around the world, are part of a wider global struggle by governments to attract businesses seeking light-touch regulation without scaring off their voters.

The new medical devices rules agreed by the European Union in 2017 will tighten control of devices before they come to market, improve transparency and strengthen surveillance by national authorities, a European Commission spokesperson said.

The new system changes less than some proposals – which envisaged regulation by a public body, along U.S. lines, replacing the existing practice of certification by profit-making private firms.

But players in medical technology – which ranges from surgical implants to scans – say it is too burdensome and is being built too slowly, risking not only hampering innovation but also harming patients by interrupting supplies.

“Immediate action is needed now to avoid severe disruption of product supply to patients and hospitals,” seven European Associations said in a joint statement last week.

All 55,000 devices certified under the old directives have to be re-certified along with other products such as reusable scalpels, nasal saline sprays and dental imaging software.

The industry says there are not enough Notified Bodies – the private firms charged with certifying the safety of devices ranging from bandages to pacemakers, and that manufacturers may have to take products off the market or delay new launches.

The situation is further complicated by Brexit, with Britain’s BSI one of just two notified bodies to have got the go-ahead to certify devices under the new Medical Devices Regulation (MDR). If Britain leaves the EU in October without a deal, certificates issued by British bodies would be invalid.