Preparing Medical Products for Market in Europe

Translating product materials is an integral part of marketing and selling products internationally. However, for pharmaceutical companies translation is not only about making a profit it will lead to medical decisions regarding dosage, symptoms, and side effects that will have an immediate effect on the health and life of the patients involved. For companies producing medical devices it involves the provision of devices that improve the comfort and quality of life and at times allow the administering of medical treatment necessary and at times save lives. An error in translation will do more than cause embarrassment.

By taking care of translation needs sooner rather than later, medical companies can take advantage and profit more from global markets. The market for pharmaceutical products in Europe is dramatically growing. Sales increased by over 200% from 1997 to 2003. During the same period, imports of pharmaceutical products into France rose by 463%. US exports of medical and surgical instruments to Western Europe increased by 38% at that time (OTEA, Trade Development, International Trade Administration, US. Department of Commerce ). Over the next 5 years it is anticipated that 90% of Life Science companies will have greater translation needs. Preparing in advance for an increase in demand for medical products by optimizing the translation process can enable medical companies to gain an increased market share.

Companies who will require more translation services include:

  • Medical device manufacturers
  • Pharmaceutical companies
  • Biotech companies
  • Diagnostic research organizations (CRO's)

Since June 14, 1998 US companies require CE marking in order to offer medical devices for sale in the EU and to EEA members. Compliance is mandatory since December 7, 2003. The CE Mark is a consequence of the Medical Device Directive (MDD93/42EEC). Companies benefit from CE marking because it generally leads to only one set of laws and regulations to comply with in designing and manufacturing for markets within Europe . Products not bearing the CE marking are not in compliance and may be restricted or prohibited from sales in the expanded European market. In vitro diagnostics, active implantables, and medicinal, cosmetic, and personal protective devices do not have to bear the CE Mark, however they have separate directives with translation regulations.

Only In Vitro Diagnostic Directives in the EU (98/79/EEC) requires translations for every country in which the product is offered for sale. Directive 90/385/EEC deals with active implantable devices, like pacemakers, all other products except active implantable is dealt with by directive 93/42/EEC. Medical Device Directives and Active Implantable Medical Directives allow each member state to determine whether translation is necessary. Presently each member state, including the 10 new member states as of May 1, 2004, have elected that translations should be provided.

Considering the growing need for translation the following strategies for medical translation should be kept in mind:

  • Create a glossary. Combine efforts with your translators to identify terms that may require new words in the target language. Determine existing accepted terms for those already established;
  • Confirm with local research staff that terminologies are developed by scientific professionals. Clarify any terminology queries;
  • Localize trademarked brand names to aid marketing and avoid confusion or even worse offense;
  • Using the most up to date Translation Memory (TM) technologies build a translation memory database for all documents. Where possible, include legacy documents in the source and target languages. This eliminates needless repetition, provides consistency of translated terms, and increases efficiency; and
  • Proofread over all repetitions prompted by the TM tool to ensure completeness, suitability, and accuracy.

If you have decided to assign the translation to in-house staff employees ensure that they have the professional translation skills, language skills, writing skills, experience, CAT tools, objectivity, and time to do the job. Not all individuals with the right language skills and medical expertise can translate. Follow a translation process that involves separate editing, proofreading, terminology checks, and QA control.

If outsourcing consider the following criteria before selecting a translation provider

  • Quality Control procedures
  • Relevant medical or technical expertise
  • Your target languages
  • Agency capability to work with the types of media format needed
  • Previous timely delivery success
  • The companies payment policy
  • Cost, communication, and monitoring processes
  • Confidentiality
  • Flexibility
  • Use of CAT tools, and
  • Discounts offered based on repetitions/similarities found with the use of CAT tools.

Not all biomedical companies have the time and translation resources to meet the challenge of the EU deadlines for compliance in-house. AbroadLink can assist by performing the entire translation process for you. We have the resources necessary to effectively and efficiently provide precise translations. Put your complex projects in our careful hands. To discuss your particular translation needs with one of our representatives call 1 800 880 5709.


The content of this article is general in nature and is not intended as business or legal advice related to an individual situation. Counsel should be consulted for specific planning and advice.