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Exporting medical devices to EU?

Medical Devices

Medical Devices

Are you looking to export medical equipment to Europe? You might not be surprised to read that exporting medical equipment is a rather complex process. And believe it or not, the translation/localization piece is the least of your worries. Why, you ask? Because EPIC Translations fully understands the requirements for medical device translations.

If you’re looking to export to Europe, then consider the following:

  • EU has 27 member countries. This list is likely to grow in the future.
  • 500 million consumers speak 22 different languages

(Un)Fortunately, all EU countries have adopted the three EU Medical Directives:

  1. Active Implantable Medical Devices (AIMD);
  2. Medical Devices (MDD);
  3. In-Vitro Diagonistic Devices (IVD).

What does this mean for medical device manufacturers? Essentially that all labels and instructions must be localized to each country BEFORE the medical devices reach the end users in all EU countries. So, if you’re looking to increase your sales and export your medical devices to Belgium; then the labels and instructions for your medical devices MUST be localized to Dutch, French, & German. For Denmark, localization must be done in Danish. For Finland, localization must be done in Finnish AND Swedish. And so forth.

Here is a complete list of the EU countries, the languages, and what exactly has to be localized:

Country Language What must be localized
Austria German AIMD, MD, IVD
Belgium Dutch, French, & German AIMD, MD, IVD
Cyprus Greek AIMD, MD, IVD
Czech Republic Czech AIMD, MD, IVD
Denmark Danish AIMD, MD, IVD
Estonia Estonian AIMD, MD, IVD
Finland Finnish, Swedish AIMD, MD, IVD
France French AIMD, MD, IVD
Germany German AIMD, MD, IVD
Greece Greek AIMD, MD, IVD
Hungary Hungarian AIMD, MD, IVD
Ireland English AIMD, MD, IVD
Italy Italian AIMD, MD, IVD
Latvia Latvian AIMD, MD, IVD
Lithuania Lithuanian AIMD, MD, IVD
Luxembourg French, German, & Liezeburgish AIMD, MD, IVD
Malta Maltese or English AIMD, MD, IVD
Netherlands Dutch AIMD, MD, IVD
Portugal Portuguese AIMD, MD, IVD
Slovenia Slovenian AIMD, MD, IVD
Spain Spanish AIMD, MD, IVD
Sweden Swedish AIMD, MD, IVD
United Kingdom English AIMD, MD, IVD

Here is a map of the EU for your reference:

EU Map

EU Map

So as you can see, exporting your medical devices to the EU is a little bit more challenging than exporting textiles or financial services. However, partnering with a Language Services Partner (LSP) that understands the rules and regulations for the medical device industry will make things much easier for you.EPIC Translations has linguists in every single country in the EU that specialize in medical devices. Thus, we can provide you with not just accurate translations, but also create a terminology database for you that will help you in your future endeavours.

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