CE Mark Solutions

The letters "CE " are the abbreviation of the French phrase "Conformité Européene" which literally means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the EU Directive 93/68/EEC in 1993.

1. CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, put in practice by many of the so-called Product Directives.
2. CE Marking on a product indicates to governmental officials that the product may legally be placed on the market in their country.
3. CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (28 countries in total), and
4. CE Marking on a product permits the withdrawal of non-conforming products by customs and enforcement/vigilance authorities.

CE Marking is required for dozens of product categories ranging from toys and consumer electronics to in-vitro diagnostics and medical devices. To obtain CE Marking approval, a manufacturer must use the services of a Notified Body, which is fundamentally an EU-approved organization that checks for conformity with essential requirements through audits of process and documentation at critical stages of product development and review.

While CE Marking is particularly designed to facilitate development of a single European market, this is also part of a greater worldwide move toward harmonized standards that increasingly lower technical barriers to trade by standardizing safety and quality requirements worldwide.

Of particular concern in the translation world are the Medical Device Directives that include:

• Medical Device Directive
• IVD Directive
• AIMD

At Translations.com, we fully understand the need for documented quality control systems, from linguistic recruiting and testing through multi-step language development and technical localization processes. Please click through the links at left for additional information about our life science practice group. We are designed to get you there faster.

Related Link

• Web resources on AIMD