European Union will keep CE Marking for medical devices

CE Marking will retain its position as the certification for medical devices in Europe, despite attempts by some companies and medical device associations to use additional proprietary marking systems.

The details of CE Marking have confounded medical device manufacturers in the EU and internationally since the concept was first introduced as a mechanism to streamline device certification.

The system was put into force in 1995 to ensure that medical devices sold on the European market met the EU’s European Essential Requirements for safety. As of 1998, all medical devices sold in the EU had to carry CE Marking.

Since then, alternatives to CE Marking have been proposed periodically, but none has gathered enough support to pose a serious threat to the system. Nonetheless, proponents of the CE Marking system have become increasingly alarmed.

“We fully support CE Marking,” said Michael Baker, director general of EUCOMED, a Brussels-based organization representing more than 3000 medical device-related businesses operating within the EU. EUCOMED has been outspoken in its opposition to alternative certification methods.

“The multiplication of quality marks and the consequent diminishment of CE Marking actually works against the objectives of global harmonization,” Baker said.

Opponents of CE Marking have noted that while marked devices sold in the EU meet the essential requirements of the appropriate medical device directive, low-risk devices such as bandages are often self-certified by a special industry organization. Moreover, CE Marking does not indicate the quality of a device, only that it has met certain standards.

Speaking at the global medical device conference earlier this year in Cancun, Mexico, several companies’ officials said they should be allowed to develop a certification system with higher standards than those of CE Marking.

“The European governments spelled out essential requirements for product safety but left it up to private bodies to develop specific standards that would conform to these requirements,” said Dr. Kalypso Nicolaidis, a lecturer on international relations at St. Antony’s College of Oxford University. “While conforming to the more specific standards developed by private standardization bodies is not required, it is often the easiest way to prove that a product meets the relevant essential requirements.”

The European Commission has remained neutral on the issue, frustrating both supporters and opponents of CE Marking. Antonio Lacerda, head of the commission’s medical devices sector, said that some alternative quality marks could indicate real added value but that others would simply be marketing tools. The commission recently sent a questionnaire on CE Marking to EU countries to determine which alternative marking systems could conceivably undermine the value of CE Marking.

EUCOMED has accused the commission of “fence sitting” on the subject and continues to press for strong support of CE Marking.

Concerns about competition for CE Marking are mounting as more countries join the EU. The Czech Republic still requires medical devices to be retested but is working with the European Commission to allow medical devices with CE Marking into the country without further testing. Neither the Czechs nor the European Commission have said when that change will take place, however.

Some EU member countries are taking the matter into their own hands. A German law keeping CE Marking as the only valid certification system for medical devices in that country will take effect next year.

According to BVMed, the German medical device association, private marks are developed to mislead the user. The organization wrote a letter to the Bundestag’s health committee strongly supporting legal protection of CE Marking and characterizing additional private marks as “superfluous.”