In-Vitro Diagnostic (IVD) Products Require Translation
by Alden Translations

To sell certain medical products in most of Europe, companies must obtain a “CE Mark”, requiring localisation of device documentation and labelling for all target markets.

  • As Europe has evolved into a unified market, product directives have been introduced to protect consumers, requiring a Conformité Européenne (CE) Mark to allow movement of manufactured goods throughout the European Economic Area. The CE Mark, seen as a trade passport, certifies that the product has been placed legally on the market. Products can be withdrawn if they do not comply with regulations. The entity covered by the CE directives includes the 25 member states of the European Union (Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom), in addition to Iceland, Liechtenstein, and Norway, which are members of the European Free Trade Association. As other countries join the EU the same requirements will apply.

During the past seven years, the European Economic Area has implemented three Directives to control medical devices, requiring many medical devices to be tested, documented, packaged and approved in particular ways.

The third and most recent directive is the IVD Directive (98/79/EC), which was approved in 1998. The transition period for complying with the directive began June 7th 2002 and ended on December 7th 2003. Since December 7th 2003, in-vitro diagnostic products offered for sale in the EU member countries must conform to IVD Directive requirements and be CE Marked.

The IVD Directive applies to devices and accessories used in diagnostics and include the related software. The classification includes the following:

  • Diagnostic and monitoring equipment for alleviation of disease, handicap, or injury
  • Blood disease test kits
  • Diabetes test kits
  • Blood group reagents
  • Self test kits (including pregnancy)
  • Instruments

These directives require translation of information related to medical devices sold in much of Europe, including documentation, labelling and user interface components.