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Over 50% of products currently exported to Europe from the United States are subject to IVD directive by European health, safety, and environmental product directives. If any of your company's exports fall into this large category and at least some of them probably do obtaining CE Marking will be crucial to your ability to compete. Many U.S. exporters, however, are still uncertain about how to obtain certification and unaware of CE Marking's potential impact on their bottom line.
CE Marking gains your firm's exports access to the European Economic Area (EEA), consisting of 18 nations. The letters ''CE'' are French for Conformit Europen, and affixing such a label to a product indicates that it underwent assessment procedures and was found to be in compliance with standards required by European Union (EU) legislation.
Companies whose products are not covered under CE Marking must qualify their Europe-bound exports one nation and one national mark at a time a tedious and costly process. Obtaining CE Marking means complying with only one set of laws and regulations. The multiple and conflicting national limitations on regulated products will be eradicated. Your products will also be safer for consumers and less liable to damage claims and liability premiums.
CE Marking is required for all products falling under the New Approach Directives of the EU, and covers large families of products, such as machinery, gas appliances, construction products, and toys. The standard also applies to specific risks, such as electromagnetic compatibility. If more than one directive applies for example, machinery that is electrically operated the CE Mark can be earned only if the product meets the requirements of all the directives in question.
All products with CE Marking must have supporting documentation: the manufacturer's declaration of conformity and the technical file of the product itself, including the standards and directives to which it complies. There are four IVD directives: Machinery (any machine with moving parts); Telecommunications Terminal Equipment (includes computer and network hardware); Electromagnetic Compatibility (most electromagnetic equipment); and Low Voltage (all electrically operated products).
There are three paths to obtaining CE Marking for your exports:
* Self Declaration. This means that either your company (the manufacturer) or a testing lab your firm hires has performed the required tests. Your company prepares the technical file and declaration of conformity upon successful completion of testing. Over 70% of U.S. products exported to Europe that require CE Marking can be self declared. This is the least costly of the three paths, but also the least reliable.
* Type Approval. This method involves a third party testing the product specifically, one of the ''Notified Bodies'' authorized by EU nations to serve as an independent test lab, perform the steps required by product directives, and verify the results. Your company prepares the declaration of conformity and affixes the CE Mark to the product after successful testing. There are some 200 Notified Bodies, all located in Europe, although some have satellites in the United States that submit results to Europe for final approval. Export managers should note that there can be long waiting lines at these testing labs don't delay until the eleventh hour. Lists of the agencies are published in the EU's Official Journal of the European Communities.
* Technical Construction File. Use of a third party is mandatory for certain products. Your company is also required to hire a third party under the Electromagnetic Compatibility directive in two general situations: cases in which EU standards are applied only in part or don't exist, and cases in which your export product has so many variations that testing each one would be impossible. Third-party testing is also required for medical devices or dangerous machines as per an IVD directive.
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