EU panel approves FDA-like requirements for medical devices (MassDevice)
A European Commission panel approves more stringent regulation of medical devices akin to the FDA’s pre-market approval program in the U.S., raising an immediate outcry from the EU’s medtech lobby.
A European Commission panel yesterday OK’d more stringent oversight of medical devices in the European Union that would require clinical trials for implants and other Class III devices across the pond.
If enacted, the new regulations would require implants like heart pumps or joint replacements to undergo a process much more like the FDA’s pre-market approval protocol in the U.S., under control of the European Medicines Agency.
The vote by the EC’s Committee for Environment, Public Health & Food Safety drew an immediate outcry from Eucomed, the European medtech lobbying group, which called the proposal “Kafkaesque” and said the regulations would “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,” according to a press release.
“No assessment has been made of any kind as to what real safety gains there would be, what delays it would cause for lifesaving devices reaching patients and what the exact cost of the added bureaucracy to European governments and industry will be,” according to the release. “Industry has calculated that proposed system will result in a bureaucratic behemoth costing anywhere between €10 billion and €25 billion Euros and that in no way achieves the shared objective of improving patient safety.”
Last week Eucomed released a small survey of its members it claimed showed that the PMA-style rules would cost €17.5 billion, or about $23 billion, if enacted. Yesterday Eucomed CEO Serge Bernasconi accused the panel of bowing to political pressure from a French breast implant scandal last year.
“Let it be clear that this is a PMA in disguise, carried out on a case-by-case basis, and will deal a blow to patient access and medical device innovation in Europe,” added Eucomed CEO Serge Bernasconi. “Also, no one has shown how any part of the proposed new PMA system would have changed the outcome of the [Poly Implant Prothèse scandal] or any other safety issue. Bureaucracy will not prevent an alleged fraud like PIP. Concrete actions do.
“Our industry is also committed to invest €7.5 billion in effective and necessary safety measures. But making us spend more than our total R&D budget for a system without any proven benefits for patients is beyond my comprehension,” Bernasconi added. “The political groups in the Parliament still have time to assess the impact of the system on patients, innovation and resource implications and fix this rushed deal into a right deal when the vote enters the plenary session in October.”
Eucomed also took issue with a provision the committee endorsed to allow re-processing of single-use medical devices, which is banned outright in France.
“Eucomed believes the measure threatens patient safety by failing to require re-processors to meet the same safety and regulatory standards of original manufacturers,” according to the release.