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IVDD, MDD and CE Mark Compliance

GLC Can Help You with IVDD and MDD Compliance

As of December 7th, 2003 all  in vitro diagnostic medical devices  (IVD) sold within the European Union must carry the CE Marking.  The CE Mark is a "certificate" indicating that the device is compliant with all rules and regulations. This directive also includes local language requirements. Additionally, MDD (Medical Device Directive) that was adopted on January 1, 1995 has similar mandates for general medical device manufacturers.

Failure to comply with IVDD or MDD and sell products in the European Union without a CE mark may have significant ramifications.  The manufacturers of such products may face criminal charges as regulatory authorities pull their devices off the shelves.

GLC's experienced medical translation and project team can help you meet IVDD and MDD compliances and sell your products confidently with a CE Mark affixed on them.  Advantages of partnering with us for your language translation needs include:

  • Expert certified medical translators in all  languages
  • QA process to deliver flawless translations
  • Experienced project managers to answer all your questions
  • FREE glossary compiling
  • Liaison with your reviewers
  • Timely delivery to meet your deadline requirements
  • Discounted rates to meet your budgets
  • FREE certification of translation

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