EU Lawmakers Propose Stricter Review of High-Risk Devices

Lawmakers in the European Union are backing a new approval and evaluation system for higher-risk medical devices.

The new system, which is intended to be more stringent than the previous one, is raising industry concern in the United States and Europe about added delays in getting new products to market. Many consider Europe’s CE mark system a quicker, more predictable alternative to the more burdensome U.S. system. In many ways, as companies seek approval in the EU first, the process has been characterized as Europe’s competitive advantage. The new system—under the control of the European Medicines Agency—would be similar to the U.S. Food and Drug Administration (FDA) premarket approval system.

Members of the European parliament’s committee for environment, public health and food safety voted in favor of a new pre-market authorization system of randomized clinical trials for implantable devices—everything from hip replacements to artificial heart valves. If the committee’s vote is confirmed by the full parliament in the coming weeks, it will form the basis of the assembly’s negotiating position in subsequent talks with EU governments to finalize the rules.

Calls to revamp the system were in large part due to a 2011 scandal involving France’s now defunct Poly Implant Prothese (PIP), which had been making substandard breast implants with industrial-grade silicone for more than a decade.

Eucomed, the European medical device trade group, was quick to respond to the vote, calling it “heavily bureaucratic.” The group, which represents Europe’s $135 billion medtech industry has said the new regulations would add years to the time it takes to bring new devices to market. The body also questions whether the EMA will have the capacity to evaluate the 400 to 600 Class III devices that reach the market each year in Europe.
The proposal, according to a statement released by Eucomed, “combines a complex, unpredictable scrutiny process with a de facto case-by-case centralized pre-marketing authorization system. The proposed regulatory system will not only unnecessarily delay by three years patient access to the latest lifesaving medical technology, but also deliver a devastating financial blow to Europe’s 25,000 small and medium-sized device makers,” adding that parliament was putting politics ahead of the needs of patients and doctors prior to upcoming elections in 2014.

The ENVI committee compromises patients and jobs in a what looks like a rushed through deal that seeks to satisfy the time pressure that Parliament feels ahead of the European elections, but not the needs of Europe’s patients and doctors. For several political groups, the outcome also represents a drastic shift away from their pro-innovation, pro-competitiveness platforms on which they are campaigning for re-election in 2014. It is now up to the political groups in light of the plenary vote in October to turn the “rushed deal” into a “right deal” for patients and jobs.

According to the trade group, the proposed system would result in additional costs of at least 10 billion euros with the potential to reach 40 billion euros, “that in no way achieves the shared objective of improving patient safety.” Instead, the proposal represents an exercise in deal making that capitalized on MEPs’ collective desire to conclude a time-consuming, very technical dossier before campaign season.

“Industry strongly believes that a move towards a system as proposed … is not the right way forward for the well-being of patients and the future of medical device innovation in Europe,” Eucomed officials went on to say in their statement. “Multiple scientific reports and studies clearly indicate that a centralized pre-market authorization system for medical devices, similar to the one used by the FDA in the U.S., will deliver no additional safety benefits for patients and will cause unnecessary delays of three to five years in lifesaving medical devices reaching patients. A case in point is the example of an innovative medical technology like renal denervation for the treatment of severe, uncontrolled hypertension in patients whose condition cannot be treated solely by pharmaceuticals. This technology is already saving the lives of patients in Europe while an estimated 7 million Americans with the condition are still waiting for this procedure to be approved.”

Eucomed officials claim that medical device manufacturers recognize that the current system needs an overhaul and acknowledge that change is necessary to improve Europe’s medical device regulatory framework. The group advocates proposed increased monitoring of device manufacturers and tougher government oversight of the 80 or so mostly private Notified Bodies that currently decide on product safety, which would lead to an EU-wide consistent, high-quality approval system “that does not unnecessary delay lifesaving treatments reaching patients and does not lead to an enormous bureaucratic burden.”