Changes Proposed to Review of High-Risk Devices in Europe

A member of the German parliament, Dagmar Roth-Behrendt, has proposed a centralized authority to regulate and approve high-risk medical devices before they are sold on the European Union (EU) market. According to Roth-Behrendt, the current system is not as cohesive as it could be. She said that the current procedure for getting a device to market in the EU has shown significant weakness over the past years and needs to change.

According to her draft report, these weaknesses include a lack of transparency, slow approval times, and products reaching market without sufficient clinical investigation and data. This, the lawmaker said, puts patients at risk.

Roth-Behrendt is proposing a system that would provide more stringent oversight for devices considered to pose the highest risk to patient populations. She was insistent on not making the comparison to the U.S. Food and Drug Administration (FDA) pre-market approval requirement for Class III (highest risk) devices, saying “the U.S. system of approval also faces some problems, and I have not used it as an example for the changes I propose.”

“The system which I have proposed—for the authorization of the highest potential risk class of medical devices—is based on the fact that, in the recent past, too many unsafe medical devices, such as hip prosthesis or breast implants for instance, have been inserted into the body of thousands of patients. Those devices had received an approval to be placed on the EU market,” Roth-Behrendt said. “We know that many of these high-risk devices are not properly tested before reaching patients and health professionals, and clinical data are often too weak since the number of patients involved in the trials is regularly too limited to be representative. This is why I believe that the current EU system of approval for devices with the highest potential risk needs a complete and overall change.”

Medical device industry advocates in Europe are not thrilled about the proposal.

“Industry continues to strongly believe that a move towards a centralized, pre-market authorization procedure is not the right way forward,” read a statement from the European medical technology industry association Eucomed. “Multiple scientific reports and studies clearly indicate that a centralized pre-market authorization system for medical devices, similar to the one in the United States, will deliver no additional safety benefits for patients and will cause unnecessary delays of up to three years in lifesaving medical devices reaching patients.”

The statement went on to point to the example of renal denervation treatments for severe, uncontrolled hypertension in patients whose condition cannot be treated solely by pharmaceuticals. According to Eucomed, EU patients are already benefitting from this treatment technology, while 7 million Americans with the condition are still waiting for FDA approval.

Eucomed has launched a campaign called “Don’t lose the 3,” referring to the supposed three- to five-year advantage the European Union has over the United States in terms of device approval. If Roth-Behrendt’s proposal becomes law, Eucomed is afraid the EU will fall behind in approving life-saving devices due to what it deems to be unnecessary oversight and regulation.

The campaign website states, “Many groups and experts in Europe, including doctors, patients and industry, agree that the current European system needs to be improved to cope with new medical technologies and innovations. But let’s keep what works and fix what needs to be improved instead of radically changing the system.”

Roth-Behrendt will now enter discussions with members of parliament in the Environment, Public Health and Food Safety committee.

Members of the committee will debate the report, table amendments and vote on the final version, after which it will be voted on in a plenary session of the parliament on May 20.