It has been more than ten years since the first CE Mark directive was published, yet some U.S. manufacturers are still struggling to understand its implications. Many that initially took a wait-and-see approach are now scrambling to comply with its requirements.
The CE Mark was created to ease free trade within the European Economic Area (EEA) by providing a unified set of health and safety requirements for various products. The EEA is formed by 15 member states of the European Union (EU)--Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, and the United Kingdom--as well as European Free Trade Association members Iceland, Norway, and Liechtenstein.
CE Mark directives and deadlines
Legend for Chart:
A - Directive
B - Inception date
C - Enforcement date
The telecommunications terminal equipment directive is the only directive that requires conformance with common technical requirements (CTRs). The CTRs are drawn up on the basis of essential requirements relating to safety, EMC, and speech qualities in connection with the public telecommunication network.
Any product that is marketed or traded within the EEA must bear the CE Mark to signify that it complies with requirements specific to one of the directives established by the European Union. These New Approach directives contain safety, health, environmental, and consumer-protection requirements for a range of products. There are currently 17 directives, each with its own enforcement date. Three of the directives--for machinery, low voltage, and electromagnetic compatibility--are currently considered to have the largest impact on U.S. exporters, due to the nature of the products they cover.
A majority of the directives are for products that the EU considers to be a relatively low safety risk. Manufacturers can comply with these directives through a self-certification process called internal control of production. Compliance with directives for products deemed exceptionally hazardous, however, requires testing and approval by a third party, or notified body. Currently there are a number of laboratories within the United States that will test and certify products to EU requirements.
"A product may still get by without the CE Mark, but it's a criminal offense. The manufacturer's officer--whose name appears on the Declaration of Conformity--can be held liable," warned Andrew Bergman, vice president of Qualified Specialists Inc. (QSI), Houston, a consulting and training company that specializes in EU preparedness. "Some companies have been told by their EU customers to get the CE Mark, although they are not obliged to do so, and some have taken it upon themselves to get it".
If customer requirements aren't enough of an incentive for some manufacturers to get the CE Mark, exposure to law suits might be. "The CE Mark is now used as evidence in liability claims," explained Richard Glaser, a consultant with SWBC International, Amersterdam, the Netherlands. "If no CE Mark exists, the [manufacturer] is automatically at fault. If the [product] does have a CE Mark [then the user may be at fault]."