Quality Marks on Firing Line at Global Medical Device Conference

European industry, regulatory officials, and private testing and certification companies have been at loggerheads for more than a year over the use of quality marks on medical products in addition to the mandatory CE mark. Prominent industry associations and some government officials have vehemently opposed the marks, saying that they cloud the meaning and legitimacy of CE marking in the minds of consumers. The debate continued at the Global Medical Device Conference in Cancún, Mexico, in January.

Speaking on behalf of TÜV Product Service Inc. (Danvers, MA), Martin Leighton reiterated his company's claim that CE marking is not an ironclad guarantee that devices conform to all of the safety requirements. While medical devices sold within the European Union must bear CE marking to show that the products have met the essential requirements of the appropriate medical device directive, low-risk devices are, in fact, self-certified, he noted. These require little or no oversight from a third-party conformity assessment body. CE marking indicates that "prerequisite essential regulatory and safety requirements have been met and it serves as a passport to the European market," Leighton said, "but it is not a quality mark." There are markets beyond the EU where CE marking is not recognized, Leighton added, and TÜV's distinctive octagonal mark enables manufacturers to clearly display testing and certification information.

Leighton also stressed that quality marks such as the one marketed by TÜV (other certification and testing houses offer their own marks to customers) respond to the needs of the global market. Prohibiting the use of quality marks other than the CE mark within member states of the European Union is a regional and thus retrograde approach, he intimated.

Response from industry came fast and furious. Michael Baker, director general of the pan-European association EUCOMED, began the volley by objecting to the "arrogance of companies such as TÜV" that are sowing confusion over the merit and meaning of CE marking. "TÜV has made a considerable amount of money placing CE marking on products, and now they want industry to invest in yet another mark." The multiplication of quality marks and the consequent diminishment of the CE marking actually works against the objective of global harmonization, he added.

U.S. director of medical operations at TÜV Product Service Inc. Martin Leighton defended the use of private quality marks at the recent Global Medical Device Conference.

John Place, director general of the European Diagnostic Manufacturers Association, objected strongly to TÜV's assertion that CE marking was not a guarantor of quality. "The directive clearly states that it is a criminal offense to place CE marking on a product that does not meet the essential requirements," he noted, echoing the position of the German ministry of health. That body has threatened to outlaw the use of private certification marks on medical products placed on the German market.

Members of industry attending the session objected to the fleeting competitive advantage the quality mark may afford. One attendee pointed out that if he were to place the TÜV mark on his product, his competitive edge would have a life span of approximately one month. "That's how long it would take my competitors to affix the TÜV mark to their products," he said. "At that point, it becomes yet another quasimandatory mark that you have to have because everyone else has it."

While the European Commission remains officially neutral on this issue, the head of the medical devices sector, Antonio Lacerda, told attendees that a distinction can be made between quality marks that do offer the consumer some element of added value and those which are nothing more than a marketing ploy.—Norbert Sparrow

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