CE Means Caveat Emptor, FDA's Burlington Tells Europeans
Norbert Sparrow
Lisbon, Portugal--Dozens of languages were spoken at the Global Medical Devices Conference, held here last week, but it was a Latin phrase that got the attention of the attendees. "Perhaps the famous CE mark should mean caveat emptor, or buyer beware," suggested FDA's Bruce Burlington, director of CDRH, to the more than 300 delegates that had assembled in Lisbon. The CE mark is a symbol indicating that products meet the European Union's safety standards.
Stressing that an unrestrained business ethic exists to maximize profits and not necessarily to ensure public health, Burlington argued that the European Union's third-party approval system is fundamentally marred by a lack of accountability. Harmonization is a laudable goal, he added, but it should not be pursued at any cost.
While Burlington and FDA certainly are not the only parties to question the efficacy of the EU's third-party review process, it was the willfully polemical nature of the comment that angered numerous delegates. "I don't see any evidence that the weight of regulation in the United States has led to the creation of inherently safer medical devices than those which are available in Europe," said Malcolm Carlisle, legal counsel for SIMS (London, UK).
Carlisle stressed that what is at stake for industry is not necessarily harmonization of the regulatory systems in effect in the individual countries, but market access. "The Medical Devices Directive does not seek to harmonize laws," noted Carlisle, referring to the transposition process whereby member states incorporate the MDD into their national laws. Because of the directive's "soft touch" approach, the EU presents the best model for the world's medical device community, Carlisle said.
Edward Rozynski, senior vice president of Global Strategy and Analysis at HIMA, concurred. He began his address on the status of mutual recognition agreements (MRA) by pointedly congratulating Europe on this new system that "gets products to patients twice as fast as the U.S. regulatory system." As far as the MRAs are concerned, there appears to be a misunderstanding about what they truly mean, continued Rozynski. "There is no common standardization or harmonization necessary in order to enter into this type of agreement," he said. "The MRA is simply an acknowledgement that a foreign body can review or inspect a product to your own requirements."
This, he continued, is already happening, citing such examples as the U.S. subsidiaries of a European testing house and notified body certifying that a U.S. product intended for the EU marketplace is in compliance with the appropriate directive. In light of this reality, "it's simply not constructive for FDA to come to this conference and tell Europeans, caveat emptor," concluded Rozynski.
Recognizing that "the situation with the United States is extremely difficult," John Clarke, principal administrator at DG III, European Commission, expressed hope that the reluctance of the United States to accept third-party testing in the EU will dissolve after a requisite level of mutual confidence has developed. Rozynski put it a bit more bluntly: "We have nothing to fear but fear itself."
The Sixth Global Medical Devices Conference, sponsored by the European Confederation of Medical Devices Associations (EUCOMED) and organized by IBC UK Conferences Limited, was held in Lisbon October 8-10.
