PARIS — In an odd reversal of roles, the European Commission (EC) has said it will streamline regulations governing medical devices in Europe and seven industry associations immediately organized a staunch opposition to the change.

Even as the most recent modifications to the EC's Medical Device Directives are being put in place by member states of the European Union, the commission unexpectedly launched a call for a consultation on a proposed "recast" of the directives that seemed to catch industry off guard.

Just as the consultation period ended in July, seven trade associations representing 95% of the medical device industry in Europe issued a joint statement saying the system is working just fine and that reopening the regulatory framework at this point "threatens the future competitiveness of our industry."

Industry already knew the EC was considering revisions to address a host of issues arising from emerging technologies, new materials, hybrid drug-device therapies and the thorny problem of single-use devices (Medical Device Daily, Sept. 6, 2007)

But the swift, unilateral action by the commission and its sweeping scope was completely unexpected.

The EC wants to consolidate its three directives for 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.

The commission also expressed a concern that some emerging quasi-medical devices are not regulated at a European level, "namely those defined as medical devices consisting exclusively of non viable human cells and/or tissues and/or their derivatives and medical devices."

The commission specifically names "implantable or invasive products that are neither medicinal products nor medical devices" such as lip implants, wrinkle fillers, tattoo needles, implanted identification chips and contact lenses, which can present the same risks as devices and are also not covered by cosmetics regulations.

Finally, the commission suggested creating a centralized system for regulating devices, potentially extending the authority of the existing European Medicines Agency (EMEA).

Where industry said certain proposals were "acceptable" though "premature," trade associations circled the wagons with the final suggestion, saying in one voice: "The Medical Device Industry does not see any substantiated evidence that there is a need for a centralized European Agency for Medical Devices."

In detailed comments to the commission, the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) said it failed to see what problem the commission was addressing by creating a specific medical device agency within the EMEA.

"There is simply no reason to assume EMEA would be more competent to evaluate high-risk class devices," than the existing system of Notified Bodies (NB) with proven competence," COCIR said, according to its published comments.

COCIR concluded that it "sees no clear benefit in such measures," and that there is no reason to take action now.

John Wilkinson, director-general of Eucomed (Brussels, Belgium), which represents 4,500 designers, manufacturers and suppliers of medical technology in Europe, told Medical Device Daily: "We are now developing and delivering to the Commission corroborative documentation and further detailed input which we will not comment upon ahead of submission."

The good news for manufacturers is that the fastest any major change could be implemented is five years, with a 10-year horizon being far more likely.

But, as the solidarity among industry associations indicates, this first small step by the EC is how processes build to monumental proportions and the whisper of a centralized authority coming under the aegis of the EMEA echoes like a shouted warning.

Both industry and the EC agree Europe's regulatory landscape is fragmented and badly needs reform.

The enduring problem is that by treaty the EC controls neither the member states' adoption nor implementation of its directives and has no power to regulate.

The problem is succinctly described in the commission's public consultation proposing the changes:

"Uniform implementation of the Directives has been hampered by national variation concerning, for example, the interpretation of the definition of a medical device and of the rules for classification and the registration procedures.

"This variation threatens not only the smooth functioning of the internal market, but could also threaten the health and safety of patients, healthcare professionals and other persons.

"For these reasons, some parts of the text should also be restructured and clarified. Furthermore, it could be useful to examine if it is legally possible to use a Regulation rather than a Directive to ensure uniformity."

With a good 10 years before any regulatory hammer could be handed over to the EC, the commission has only soft tools at its disposal.

In its consultation, the EC notes that Europe's major trading partners are increasingly aligning legislation to the Global Harmonization Task Force (GHTF) model and asks to what extent this model can help smooth European regulations, and therefore competitivity in the sector.

COCIR in its comments says, "The major effect of applying the GHTF model is that better products arrive earlier to the market at a lower cost, due to the increased markets."

With a note of irony, COCIR adds, "there is no reason why EU legislation should not be fully GHTF-compliant as that model is based on the European regulatory model."

In the joint statement, the seven European industry associations — including Eucomed and COCIR — say the existing European regulatory framework for medical devices, consistent with the GHTF principles, "is working well, and considers the proposal to recast the medical device legislation is premature."

The industry associations add that the proposed consolidation is not necessarily a simplification of European regulations.

They also remind the commission it has more immediate obligations to assure implementation of the current directives and that they are enforced with requirements for putting in place a European database for device vigilance, as well as elimination of national deviations to EC directives.