A NOTE FROM THE EDITOR

Do Private Certification Marks Threaten the Stability of CE Marking?

CE marking has come under a lot of fire in its brief existence. One memorable salvo came from Bruce Burlington, the former head of US FDA's Center for Devices and Radiological Health. Addressing attendees at the 1996 Global Medical Devices Conference in Lisbon, Portugal, he suggested that perhaps CE should stand for caveat emptor (buyer beware). More recently, the French dealt a crippling blow to the free circulation of CE-marked products throughout the European Economic Area. The government now requires manufacturers of some high-risk devices to file a "declaration" with its new health safety agency three months prior to placing the product on the national market. The latest threat to CE marking comes in the form of voluntary markings issued by certification organizations, a practice that has been denounced by the European Commission, EUCOMED, regulatory authorities, and many members of industry.

If these private certification marks gain widespread acceptance among consumers and industry, cautions Joseph Putzeys, head of the European Commission's medical devices department, they could render CE marking superfluous. That could lead to an erosion of the single market, he adds. There is no justifiable reason to run this risk, according to Putzeys, because CE marking provides sufficient guarantees that a product meets the essential safety requirements of the medical device directives.

The folks over at TÜV Product Service (München, Germany), which issues the TÜV-Mark, see things from a different perspective.

"The widespread opinion among manufacturers and end-users that CE marking stands for tested quality is a fallacy," says Claudia Pelster-Bade from TÜV's marketing department. "CE marking of Class I products is based on the manufacturer's self-declaration. He judges whether the product complies with basic European requirements or not," she says. Even Class II and Class III products do not automatically undergo product testing by a third party, she adds. The value of the octagonal TÜV-Mark, according to Pelster-Bade, is that it clearly indicates the product has achieved certification to both EU quality systems and to specific product requirements. Consequently, CE marking and the TÜV-Mark serve a different purpose and should not even be compared, she argues. "CE marking is aimed at the regulatory authorities in the member states, whereas our voluntary mark is primarily for the consumer's benefit and crosses borders worldwide."

Oddly, the Medical Devices Directive (93/42/EEC) provides little in the way of legal guidance that might shore up the commission's efforts to prevent the marketing of these "rival" marks. Article 17 of the MDD prohibits manufacturers from affixing marks or inscriptions that "are likely to mislead third parties with regard to the meaning or graphics of the CE marking." The article goes on to state, however, that "any other mark may be affixed to the device . . . provided the visibility and legibility of the CE marking is not thereby reduced." Short of proving an intent to mislead, the commission is left with few options to press its case other than to pound on the bully pulpit.

The commission does have industry on its side—for now. Device manufacturers are understandably reluctant to incur yet another fee. More importantly, the possible reemergence of a fractionalized market—even if the prospect is remote—is of great concern. But there is also the reality of the marketplace. No company will sit idly by while a competitor gains even the perception of a competitive edge by placing a voluntary mark on its products.

If industry were to adopt the use of private certification marks on a large scale, would the implication be that CE marking is no longer needed and that the single market for medical devices will fritter away, as Putzeys suggests? I tend to think that he is overstating the danger. Having said that, however, it's certainly in the device industry's best interest to carefully consider the unintended consequences of a marketing decision that, when all is said and done, may yield little more than a short-term commercial advantage.