May 2007 - Global View Newsletter
CE COMPLIANCE: WHAT'S AT STAKE
The European Union currently consists of 28 countries with 22 languages and another 6 countries and 6 languages are scheduled to join by 2008.
The development of the European Union has created structure in many ways, including import, export and member country commerce. One of the regulatory methods imposed to standardize product safety, efficiency and effectiveness is the CE Marking.
Organizations currently doing business in the EU countries are already aware of the imposition of this requirement, however, companies wishing to expand sales to these areas must evaluate the mandates closely before extensive time, money a effort are expended.
The CE Marking requirement incorporates over 25 Directives including Active Implantable Medical Devices, Construction Products, In-Vitro Diagnostic Medical Devices, Machinery Safety, Medical Devices, Toy Safety and many more.
Costs:
When determining the value and possible ROI of a product, an organization must consider the all of the costs involved. Not just in product development, but also in absolute CE compliance, which includes strict language translation requirements. In many of the directive, translation must be provided into the country’s native language for labels, instructions, operation and maintenance manuals, installation guides, packaging and some marketing materials.
Benefits:
With 28 countries and 22 languages involved, the EU has a potential of 445 million consumers. As with other quality assurance procedures such as ISO certification, the CE Compliance not only
allows for trade within these countries and between companies, but it also helps to standardize and assure the overall product quality.
Risks:
Although many of the Notified Body Certification Managers, the agency in charge of overseeing compliance of products, are overwhelmed with work, if reason arises to investigate a product that is in non-conformance, the costs are high. Many of the reasons surrounding European Authority suspicion center around suspect Declarations of Conformity, the non-existence of translation, competitor complaints, accidents, customs checks and more.
Many organizations are tempted to utilize non-professional or distributor channels to satisfy the language requirements because the initial investment can seem quite high. However, it must be taken into account that if the information is translated, but not done accurately, therefore out of compliance, liability falls back onto the original manufacturer and costs for corrective action can be more than some companies can bear. Some of the actions that can be taken are cessation of production, cessation of sales, tarnished image due to investigative procedures, re-development of compliance materials, both in the native language and in the translations, costly legal battles and more.
Conclusion:
The European Union is a great place to expand business, however, caution must be taken to ensure that ALL bases are covered adequately when applying for proper certifications. Although the cost of total compliance up front may seem steep, non-compliance can be detrimental in terms of cost, and tarnished image.
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