Feature: Change sought in European device approval process

W. Douglas Weaver, MD, past-president of the ACC and Darin chair of cardiology and co-director at Henry Ford Heart & Vascular Institute in Detroit. Image source: Henry Ford Heart & Vascular Institute

During a recent meeting in January in France, in which regulators and physicians from the U.S. and the European Union (EU) met to discuss ways to improve the EU medical device approval process, it was determined that it would be better to see one regulatory body for the entire EU, rather than separate approval bodies for each country. The attendees also are seeking more experts specific to the device in question involved in the approval process.

"In recent years, most early discovery and development of medical devices occur outside the U.S., as the regulatory hurdles in Europe are not as steep and time for approval is much quicker," Douglas W. Weaver, MD, past president of the American College of Cardiology (ACC), who represented the college at the meeting, told Cardiovascular Business News.

Without having one centralized regulatory body for device approval, it is possible that a country's panel of experts will not consist of anyone with a particular expertise, for example, in circulatory devices. It could be tempting for developers to seek out countries that would give them an easier route to approval, "potentially compromising the safety of patients who get devices that have not been adequately tested," said Weaver, who is co-director of the Henry Ford Heart & Vascular Institute in Detroit.

The meeting was spearheaded by the European Society of Cardiology (ESC) and was attended by representatives from industry and regulatory bodies from both the EU and U.S., including the FDA.

"The EU enjoys the ability to foster innovation and doesn't want to lose that edge," Weaver said, adding that medical device companies often are smaller start-ups with limited funding. "The U.S. environment can favor large medical device companies because they may have the wherewithal to better navigate through the U.S. process versus smaller companies."

After these smaller companies gain EU approval for their devices, they can begin to sell them, garnering cash flow that "hopefully enables more research into the safety and efficacy of the product," he said, "which they can then use for FDA consideration."

The EU Commission with oversight into this matter will meet in a few months to discuss the approval process. The ESC and ACC want the proceedings of the January meeting to be provided to the commission as background material. And they want to give the commission recommendations for changes in the regulations, Weaver said.

"I am hopeful that something will change. The white paper produced from this meetings will likely be useful to the EU commissioners and to the FDA," he concluded.