STUTTGART, Germany — It's back to business as usual in Europe for medical device regulations with nothing but confusion on the horizon as far as any expert can see.

Last summer, the European Commission sparked a very un-Brussels controversy with a sudden and startling proposal to consolidate its complex set of medical device regulations and create a super agency to oversee both medical devices and pharmaceuticals (Medical Device Daily, Aug. 27, 2008)

Three prominent players in the debate updated their positions in presentations during the MedTec 2009 gathering here, agreeing the soonest any recast of European Medical Device Directives could be put in place would be 2015, if then.

John Brennan, director for regulatory affairs at Europe's leading med-tech trade association, Eucomed (Brussels, Belgium), exuded a zen-like calm as he reminded the audience the term for the current European Commission expires this year and a new commission with new faces and a new agenda will come to power in 2010.

"We have entered a period of reflection and discussion with the current Commission," he said in eloquent Brussel-ese.

Peter Bischoff-Everding from the European Commission's Medical Devices and Cosmetics Division of the Directorate-General for Enterprises and Industry said that a lot of attention has been given to the proposed recast of Medical Device Directives and people may have forgotten there is a major revision to existing directives on the table.

"The clock is ticking," he said, referring to the March 2010 deadline when Directive 2007/47/EC will become a mandatory requirement for the 27 member states.

A sweeping revision of regulations adopted in 1990 that are ill-suited to today's technology and applications of medical devices, the transposition of the European directive into national law has been roundly ignored by most member states.

Despite the formidable sound of a European directive, the European Union (EU) has no mandate in its treaty to regulate health affairs and directives are only guidance for national legislation.

The result is a rich opportunity for consultants to guide medical device manufacturers through a bewildering landscape marked by towering European directives with fragmented and shifting national rules.

Meanwhile, Mika Reinikainen, managing director of the consulting firm Abnovo (Weybridge, UK), who organized and chaired the session at MedTec, offered a fresh perspective, saying that by 2020 legislative systems will be overwhelmed trying to regulate emerging technologies in any event and that cost, not laws, will more likely be the controlling factor for utilization.

A proposed revision of EU Medical Device Directives dating back to the 1990s is long overdue. As guidance to national laws they could be simplified as there are currently three directives covering active implantable devices, medical devices and in vitro diagnostic devices, as well as the six subsets of directives that either modified or implemented the three principal directives.

Brennan agreed the scope is too narrow as many newer technologies are not covered, including especially the recent combination of drugs and devices.

Market surveillance is not coordinated and vigilance in Europe amounts to 27 different reactions to any problems.

The EC's Bischoff-Everding said surveillance and vigilance is essentially an email alert system in Europe with sometimes disastrous results for manufacturers who have seen Europe-wide markets destroyed by claims of a single regional distributor.

Brennan also said Eucomed agrees the system of notified bodies, which grant CE-mark approval, should be revisited to improve performance.

"We have 80 notified bodies among 27 member states, with so many designated as competent for reviewing all medical devices, which is something I have trouble believing," he said.

But Brennan said the EU proposal to recast directives put at risk the New Approach principles underlying the three current Directives that has become a passport to Europe's internal market, fast-tracking the introduction of novel technologies with a CE mark for safety compared to the "more burdensome systems in Japan or the United States."

"The current system fosters a high level of innovation and competitiveness," he said. "Europe's citizens are consistently two years ahead of the patients in the United States for access to new treatments and 10 years ahead of Japan."

"What could be lost with the proposed recast are the benefits this has brought to Europe," Brennan said. "There is a proven high level of safety in Europe's methods. There are not bodies in the streets, so we are not talking about legislation to react to widespread adverse events.

"If we take this away, the whole system of benefits to patients and industry collapses," he said, adding the current system encouraging novel devices creates jobs in Europe.

Brennan added that the involvement of a super agency in regulating medical devices would increase the current level of approval costs for a device from an estimated average of €20,000 ($25,000) to between €160,000 ($188,000) and €330,000 ($414,000).

Eucomed proposes going forward with a merger of the Active Implantable Medical Device Directive with the Medical Device Directive, and then to use the time afforded with the change of the Commission in 2009 to create a high-level think tank to solve the remaining challenges.

Brennan also urged the Commission to take time to analyze the impact of Directive 2007/47/EC as it moves toward implementation in March of next year.

Meanwhile Bischoff-Everding said the EC is currently contemplating "infringement procedures" for member states that have failed to transpose the guidance of Directive 2007/47/EC and that he hopes that the coming months will see more states adopting the guidance into national law "to assure a level playing field in Europe."

He said that the Commission is planning a follow-up on a December workshop on reprocessing of medical devices, with an eye to issuing a report, though he could not say "if it would be the case that it is issued September 5, 2010, as targeted in the directive."

The most light-hearted moment for the audience in a morning filled with regulatory affairs and untranslated official-speak was a discussion of the Eudamed database that seeks to register medical devices with a goal of strengthening market surveillance and transparency.

Introduced by a 1998 directive but not given a deadline until the proposed 2007/47/EC Directive, Eudamed "for some is essential, while for some it is the epitome of the failure of the internal market effort," Bischoff-Everding said.

The database is operational, "but only some nations use it," he admitted, adding that "other nations have invested significantly in establishing their own databases for surveillance and it would not be easy to convince them to abandon their systems for Eudamed that they consider too simple."

In his look to the future, Reinikainen elicited the only laughter from the audience when he observed, "Who knows? Eudamed may happen!"

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