BIRMINGHAM, UK — It is going to take a tragedy to bring about true pan-European harmonization of regulations for medical devices

Without a mandate in its treaty for health issues, the European Union (EU) can only issue guidance and directives to influence national regulations in the 27-plus nations which, to different degrees, follow its advice.

During a day-long session of updates on the EU Medical Device Directive at MedTec UK 2008, held here last week, the changes to the draft directive were outlined as this perpetually proposed document crawls down the finish line of a torturous course through the Brussels-based bureaucracy.

“My guess is that a major public scandal will change everything overnight,” said Mika Reinikainen, managing director of AbNovo (Weybridge, UK), at the end of his presentation, the third in the morning series dedicated to the Medical Device Directive.

“We have had some close calls,” he said, citing the stress fatigue with the Bijork-Shiler Heart Valve that killed 600 people. “A major failure of the system is coming.”

The new directives tighten the role of the European Commission (EC) in coordinating uniform application of the directives, according to Jeremy Tinkler, director of regulatory affairs at MedPass International (Paris), who also presented an update during the session.

There also is a clarification of Essential Requirements (ER) that includes more stringent data requirements and stricter scrutiny, Tinkler said, primarily for post-market vigilance as pre-market product approval remains strictly national.

Which creates the potential for the tragedy predicted by Reinikainen.

Like a policeman on the sidewalk, the EU will not have jurisdiction to act until a crime is committed.

Even without a tragedy, Europe is operating under a system “that tempts revolution,” Reinikainen said.

“We have created a system that is growing and becoming more complex,” he said. “It will necessarily degenerate into a revolution to respond to an ever more complex system raising an increasing number of unresolved issues and new challenges.”

Short of the wide-scale popular movement to give it greater authority, the EU continues to fine tune directives and codify the diverse standards of the member nations in order to create a shared document to influence the member nations.

It is a sweeping work that ranges from high-level policy issues to wrestling with the linguistic linguini of clinical nomenclature.

It may be administrative work to define a clinical incident in several dozen languages, but somebody has to do it to push the reality of a single market in Europe forward another step.

Tinkler said a new definition of clinical evaluation, based on what previously were guidelines in Medical Device Vigilance 2.7.1, has been formally adopted.

Post-market clinical follow-up now becomes an integral part of clinical evaluation, he said, along with a tighter definition of clinical data.

The new directive, significantly, gives the EC greater scrutiny for corrective actions in the event of a safety threat and the ability to intervene.

Europe will remain an uneven playing field, he said, as clinical evolution still comes down to national interests ,which by design assures there is never going to be consistency in pre-market evidence.

Because the country-based Notified Bodies (NB) are not consistent in the pre-market stage, the commission is focused on post-market actions

Reinikainen said that with 80 different NBs for medical devices in Europe, there is not any way they can all cover all types of devices.

“It is a legal fiction that they are all equal,” he said. “What we have is specialization and this is going to continue, especially in regards to developing technologies such as nanotechnologies or for drug-device combination where there are very few Competent Authorities or Notified Bodies to be consulted.

Dario Pirovano, director of regulatory affairs for Eucomed, an association representing 4,500 medical device makers, said changes to the requirements include new design principles that for the first time introduce the idea of ergonomics for medical devices in Europe.

“Design shall take into account the expected skills and knowledge of the user to reduce use error,” he cited from the draft directive, reminding the audience that demonstration of conformity to these principles now include a clinical evolution.

“The language may say ‘warmly recommended,’” he said, “But in practical terms this means clinical investigations are now essentially obligatory in Europe.”

Reinikainen said his advice to companies is to never neglect the clinical data.

“A product needs to have the best possible evidence based on its clinical safety profile,” he said, urging companies to maintain solid post-market surveillance and then to deal with any vigilance cases vigorously, “or you will face the phenomenon of creeping corrective actions.”

“The silver lining in Europe,” he said, “is for people working in regulatory affairs, who are guaranteed full employment.”