Euro device makers cry 'nay' on FDA-like proposal for medtech review

September 26, 2012 by MassDevice staff

Medical device makers warn against new guidelines that would establish a central FDA-like body to oversee pre-market medtech review for the European Union.

European Commission flag

Medical device groups were quick to criticize the European Commission's newly released medical device regulatory guidelines, saying certain updates stall innovation rather than bolster safety.

European medical device lobbying group welcomed most of the proposed measures, but took exception to the so-called "scrutiny procedure," through with a central panel of advisors would monitor the various assessment agencies that currently oversee medical device control in the European Union.

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"This procedure will fundamentally change the current system and will not lead to the desired outcome of increased safety for patients," EU medtech lobbying firm Eucomed wrote in a statement to the media. "The measure would address some political calls to move the system towards a centralized pre-market authorization system as found in the U.S. but will ultimately result in harming European patients and negatively impact mostly European small and medium sized enterprises."

The medtech groups arguments echoed those they made earlier this month when Eucomed warned that more stringent oversight may delay medical device review, thus slowing new products from reaching the market and patients in need of the life-saving technologies.

European authorities have been assessing medtech review standards, which haven't changed much in 2 decades, since the European Commission in 2008 identified several vulnerabilities. Regulators came under intense pressure to revise security standards for medical devices after a wide-scale breast implant recall dramatically exposed weaknesses in the system.

"The existing regulatory framework has demonstrated its merits but it has been in place for 20 years and like any regulatory regime dealing with innovative products, needs revision," according to the European Commission's working proposal. "Moreover, it has recently come under harsh criticism in the media and the political arena."

Late last year French regulators discovered that medical device maker Poly Implant Prothese had been sneaking substandard silicone into its breast implants for more than a decade.

The PIP implants evaded notice despite inspections at manufacturing facilities because the company was given 10 days notice prior to the checks and workers concealed the problem silicone, according to reports.

Medium and high risk medical devices in the EU are not subject to pre-market authorization by a regulatory authority, but instead undergo a certification process by a "notified body," which grants the products approval in all markets that accept the CE Mark. The U.K.'s Medicines & Healthcare Products Agency monitors product alerts, but can't act against a manufacturer unless it receives a product failure report.

French authorities started a criminal investigation of Poly Implant Prothese after receiving 2,000 complaints from women who received the PIP implants.

"Just a few months ago, everybody was shocked by the scandal involving fraudulent breast implants which affected tens of thousands of women in Europe and around the world. As policy makers, we must do our best never to let this happen again," European Commission Health & Consumer Policy Commissioner John Dalli said in prepared remarks. "The proposals adopted today significantly tighten the controls so as to ensure that only safe devices are placed on the European Union's market at the same time, they foster innovation and contribute to maintaining the competitiveness of the medical device sector." 

The high-profile ruckus over faulty implants left European regulators at the center of public outcry. Medical device makers often cite the EU's review system, which is less stringent than in the U.S., as an example of how the FDA might be faster and more efficient, but some have had harsh words for the CE Mark process, saying it uses the same lax structure to review pacemakers and electric toasters.

"Where there have been isolated instances of devices that were associated with complications, those have disproportionately occurred in countries that have earlier approval – and that tends to be Europe," Cardiff University cardiologist Dr. Alan Fraser, who led a E.U. regulatory review panel at  the European Society of Cardiology meeting in Paris last August, told reporters at the time.

The European Commission's new guidelines hope to address some of the concerns by establishing a comprehensive database of devices and developing more coordinated efforts to monitor device safety across EU nations, moves that Eucomed "strongly supports," according to a press release. But the group warned that regulators had gone too far and that new guidelines would delay life-saving medical devices from reaching patients, noting reports that centralized pre-market authorization systems may delay a device from the market for 3 to 5 years.

"I urge all decision makers who want to make fundamental changes to the European system for medical devices to tread with caution," Eucomed chairman Dr. Guy Lebeau said in prepared remark. "European patients and European medical research and innovation have benefited heavily from a system that is the world's fastest in providing patients with life-saving technologies while not compromising safety. I fully agree that changes need to be made to the current regulatory framework but let's make sure we keep the best system for patients and medical progress in Europe."