;   Medical Translation Insight: Primer: Directives offer keys to European marketplace - ForeignExchange Translations

Directives offer keys to European marketplace (medical translation)As the European single market has evolved, product directives - and the CE Mark that indicates compliance with them - have been introduced to ease the movement of manufactured goods throughout the European Union.

The economies of these advanced nations are complex and collectively enormous. Directives now cover dozens of categories of products sold within them, ranging from construction materials to explosives, recreational vehicles, gas appliances and toys (the very first product to receive a CE mark was a teddy bear).

The "CE" in "CE Marking", by the way, appears to have no agreed upon literal meaning. It may be an abbreviation of French phrase Conformité Européene, " meaning "European Conformity," but there is no consensus on this. In any event, the actual CE Marking is the manufacturer's placement of the letters "CE" on those products intended for distribution within the European marketplace.

Both consumers and manufacturers are intended to benefit from the directives. They create product consistency and reliability and provide an assurance of safety for consumers. For manufacturers, they remove the trade barriers imposed by a hodgepodge of national regulatory systems and approaches-often at odds with one another-and replace them with a pan-European process whereby compliance with a single set of regulations allows access to the colossal, multinational European marketplace.

Three directives on medical devices have been promulgated. The first, dealing with implantable devices, like pacemakers, went into effect in 1993. The second "general" directive covers all medical products except implantable and in vitro diagnostic devices. It became effective in 1995. The most recent of the three directives is the In Vitro Diagnostic Directive (IVDD), approved in October 1998.

What is CE Marking?
By adding the CE Mark to a product its manufacturer declares that it complies with all applicable directives. Depending on the level of risk inherent in the product's use, its manufacturer will either be permitted to self-certify that the product complies with the directive, or will need to obtain that certification from an authorized third-party organization (referred to, for instance, in the IVDD as a Notified Body). These organizations are independent testing laboratories authorized by the European Union to evaluate products and issue reports and certificates attesting to product conformity with the relevant directives.

CE Marking and a Declaration of Conformity are required for most products sold in the EU, including all those covered by the IVDD. Most products can be self-assessed by the manufacturer to meet IVDD's "essential requirements." The ability to "self-declare" saves considerable time and expense, but while the CE Marking opens a product's access to the European marketplace, it is not intended as an indicator of approval, certification or quality, but simply declares the manufacturer's recognition of its responsibility for product safety and quality.

There are several key steps a manufacturer must take in the process of CE Marking:

  • Preparing a detailed technical file that describes the product and its usage, effectiveness and safety considerations;
  • Preparing and signing a Certificate of Conformity;
  • Registering the product with the countries in which it will be sold;
  • Identifying an authorized representative in Europe who will answer inquiries about the product and take necessary actions should any "unforeseen adverse incidents" occur from the use of the product;
  • Adhering to the packaging and information requirements of the directive, including the translation of these materials into the national language or a language deemed acceptable for this purpose by the country in which the product is sold.
For a more detailed look at European directives and CE marking take a look here, here, and here.

ForeignExchange Translations provides specialized medical translation services to the world's largest medical device and pharmaceutical companies.


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