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What Organizations Need to Know about European Product legislation and CE Marking when Producing or Exporting their Products to the European Union

By Sabrina Vink

European-wide product legislation and the CE Mark directly affect industry both within and outside the European Union. This product legislation contains essential requirements concerning safety, health, environment and consumer protection.

CE Marking

The CE Mark is a European proof of conformity with the European product legislation and is also described as ÏpassportÓ that allows manufacturers and exporters to circulate products freely in the European Union amongst the different Member States. Not only the manufacturers and exporters, importers are responsible for the CE Mark, but also engineers, designers and innovators.

When a producer is in the process off CE Marking its product, these matters are of importance and are applicable:

  1. Determine which European directive(s) applies to your product
  2. Check what method of certification is allowed
  3. Conduct a European Standard research
  4. Draw up a risk assessment
  5. Apply technical safety regulations
  6. Formulate Safety Requirements
  7. Write a user manual
  8. Test the results on safety
  9. Draw up a Declaration of Conformity
  10. Compile a Technical Construction File
  11. Register the name and address of the producer
  12. Apply the CE Mark.

The implications for manufacturers and exporters

One of the objectives of the European Union is the realization of an internal (single) market: a market in which products can be traded freely without any trade restrictions. This offers great advantages to manufacturers and exporters to the European Union since it eliminates differing national product regulations amongst member states of the European Union.

The consequences of the European legislation is that manufacturers and exporters have to comply with mandatory EU regulations, carry out associated procedures and develop a uniform standard system for complying with health, safety requirements and documentation.

Products, which do not carry the CE Mark and are not in compliance with the directives, may be restricted, prohibited from sale or forced to withdraw from the European market. Manufacturers and authorized representatives or anyone responsible for placing products on the European market can be held personally responsible and liable for damages or injury.

European product liability

Since the introduction of European product legislation and CE Marking, product liability has become a very important factor for the manufacturer, exporter or importer in conducting trade in Europe. The central element of European product legislation is user safety.

The legal concept of product liability is the same in the European Union as it is in the United States, although the scale of award in the United States is considerably higher. Any product manufactured or imported into the European Union which causes damage to individuals or property is covered by the Product Liability Directive (85/374/EEC). This directive provides the right of civil action for product liability to all citizens of the European Union.

If damage or injury is sustained from a particular product, the user may hold the manufacturer, authorized representative, agent or importer responsible. European legislation in the area of product liability allows users of products to claim damages as the result of an injury. All manufacturers, exporters and importers have a responsibility to ensure that the products they place on the market are safe. European product liability legislation provides instruments and enforcement for user who wants to claim damages.

Liability aspects should be covered not only in the CE Marking administrative requirements such as the declaration of conformity, technical construction file and user manual, but also in the sales contract.

Consultants Europe with head quarters in Weesp, the Netherlands, is an international technical and legal organization with expertise in the certification and testing of products that are sold or traded on the European Market. E-Mail:

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