LONDON One year on from a breast implant scandal that shook confidence in Europe's light-touch system for regulating medical devices, lawmakers and manufacturers are at loggerheads on ways to protect patients from shoddy products.
Companies that make implantable devices such as new hips and heart stents accept the need for change to the current set-up but oppose a radical overhaul, arguing that would delay the launch of new devices by years and stifle innovation.
The European Commission, the bloc's executive arm, has proposed a new level of scrutiny, and some members of the European Parliament want a whole new system of pre-market approval that would raise the bar still further.
National governments also take differing positions, with France arguing EU laws must be "radically redrafted", while Britain opposes big changes.
The issue will come to a head at a European Parliament committee on February 26, where officials, industry leaders and doctors' representatives will argue over the way forward.
Dagmar Roth-Behrendt, the German lawmaker chairing the panel, is convinced Europe needs a more rigorous system for testing medical devices before they are approved.
"We absolutely need that," she told Reuters. "We don't need it for every medical device, but for certain medical devices, without any doubt, we need a more stringent prior authorization system."
Like some top doctors, she believes the current system built on around 80 Notified Bodies - mainly private firms scattered across Europe - is simply not up to the job.
Panos Vardas, president of the European Society of Cardiology, said there were "major deficiencies" in the current system and a more coordinated approach was vital. Cardiologists are big users of medical devices, ranging from stents that prop open arteries to pacemakers and artificial heart valves.
The negotiation process between governments, parliament and the Commission is likely to be lengthy, and new legislation may not come into force across the EU until as late as 2019.
NEEDLE IN HAYSTACK
Critics say Europe's weak regulation is partly to blame for allowing France's Poly Implant Prothese (PIP) to manufacture for up to a decade substandard silicone breast implants that were used by hundreds of thousands of women around the world.
But EU trade group Eucomed, representing some 22,500 device companies, argues no system could stop a fraud like PIP. It also questions whether a different regime would have stopped risky metal-on-metal hip implants reaching the market, given such hips were also approved under the more stringent U.S. system.
A key debate is whether Europe should shift to a centralized system as in the United States, potentially by folding devices regulation into the European Medicines Agency (EMA).
EMA boss Guido Rasi, who will address the February 26 meeting, said in an interview last year there was an "urgent need" to regulate devices as tightly as drugs, although whether the EMA should play a role was up to politicians.
That notion alarms Eucomed's CEO Serge Bernasconi.
"If Europe were to switch to a centralized system, we expect that, once the new system is up and running, patients will experience a 3-5 year unnecessary delay in receiving medical devices compared to today's situation," he said.
And getting such a system up to speed could cause an additional delay of one or two years, he added, undermining Europe's leading position in devices innovation.
An analysis by Boston Consulting Group last year found high-tech medical devices were, on average, made available in Europe 43 months before reaching the U.S. market.
The European Commission's answer is to reform the current decentralized system by allowing a new Medical Device Coordination Group to request additional assessments - such as longer or larger clinical trials - for some so-called "Class III", or high-risk, devices.
Manufacturers, however, fear this approach will be random and akin to looking for "a needle in a haystack", with little chance of picking up problems.
Major makers of medical devices include Johnson & Johnson, Medtronic, Boston Scientific, Abbott, Allergan and Smith & Nephew.
The industry backs the Commission's goal of improving standards at Notified Bodies, but would rather this was done by selecting only the best ones to approve higher risk devices, rather than introducing an extra layer of scrutiny.
More than 500,000 medical devices are sold in the EU, ranging from bandages, dentures and wheelchairs to pacemakers.
They are regulated under the Conformite Europeenne system, which is also used for gadgets like toasters, though getting a "CE mark" for a medical device is tougher than for such household appliances.
(Editing by Will Waterman)