Language Requirements for EU Medical Device Labels

Translating labeling for medical devices designed for lay users is a given and effectively non-negotiable. In the case of medical devices for professional use only, however, a certain degree of latitude exists in the EU for medical device manufacturers.

The majority of EU member states require medical device labeling to be in their official language regardless of whether the device is intended for layman use or professional use. However, some member states will accept labeling provided in English as long as the device is for professional use only.

In practice, many manufacturers choose to translate labeling for all EU countries in which they market their medical devices for professional use, regardless whether this is actually a requirement or not, despite the additional costs. It is another way of minimizing the potential risks associated with using their products and so a sound risk-reduction measure. It is also a strong marketing tool.

This article was written jointly by Moravia's Libor Safar, and Helen Colquhoun and Cheryl Hill from CROMSOURCE, and includes results of the research that CROMSOURCE conducted among individual competent authorities of each of the twenty-seven EU member states. It was published in MultiLingual Computing magazine #130 and covers the following:

  • Current medical device regulations regarding labeling language
  • How the regulatory process for medical devices and its translation requirements differs from the approach that exists for medicines
  • European Commission's Roadmap 2012 for medical device regulations
  • Risks of non-compliance
  • Where English is acceptable, and where not
  • e-Labeling

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