Understand Regulatory Translations on the Multilingual EU Market

Selling medicines and medical device products on the EU market can be challenging due to the regulatory system’s complexity and the union’s 24 official languages. Manufacturers, drug sponsors, importers, and distributors should be familiar with the multilingual union framework to understand how language is regulated and processed under the EU legislative system.

EU’s Multilingual Policy and Regulatory Translations

The European Union is founded on a multilingual policy. This policy is part of the union’s efforts to promote:

• Linguistic diversity
• Intercultural dialogue
• Foreign language competence

Under this policy, the European Parliament considers all languages equally important, and union-level legal acts are published in all 24 official EU languages.

Under the language policy, EU Member States have exclusive rights to determine national language arrangements in their respective jurisdictions. This is established in Articles 6 and 8 of Regulation No 1 on the determination of languages used by the European Economic Community (EEC):

The EEC consists of all EU Member States, Norway, Iceland, and Liechtenstein. Since Norwegian and Icelandic are not among the 24 official EU languages, they may be required for regulatory translations.

Due to the Member States’ mandate to determine local language requirements, Union-level legal publications (such as the EU Medical Device Regulation and the EU Clinical Trial Regulation) do not specify which national languages are required. As such, language requirements haven’t been harmonized like the new regulations’ technical requirements. Manufacturers, trial sponsors, importers, and distributors must consult the EU and national regulations to confirm the drug or device’s regulatory translation needs.

EU’s Official Languages

Across its 27 member states, the EU currently has:

• 24 official languages
• Three alphabets
• About 60 other languages spoken in the community
• 175 nationalities

According to the Special Eurobarometer report “Europeans and their languages,” 54% of Europeans can converse in at least one additional language. About 25% can speak at least two additional languages. Some Member States, such as Belgium, Finland, and Luxemburg, have more than one official language. In these territories, local language requirements will often involve regulatory translation into more official languages.

The 24 Official EU Languages Across the 27 EU Member States

The Digital Age and Language Diversity in the EU

In 2018, the European Parliament published a resolution on language equality in the digital age. According to the resolution, over 20 European languages are in danger of extinction due to digital communication. The Parliament states that the EU and its institutions have a duty to preserve and promote linguistic diversity in the union. It calls on Member States to boost usage of multiple languages in digital services (such as mobile applications) and to ensure databases and technologies are available in all EU languages.

Impact on Regulatory Translations and Global Regulatory Solutions

The lack or delay of regulatory multilingual terminologies and databases to support medical products and harmonized digital communication directly impacts manufacturers and providers of regulatory services or life sciences language services. An example is the European Medical Device Nomenclature (EMDN). EMDN was established as part of the European Database for Medical Devices (EUDAMED) under MDR and the IVDR. The EMDN currently exists only in Italian and English. The translation into the remaining 23 official EU languages isn’t available yet. This is despite all official EU languages being recognized as highly important in the MDCG 2018-2 document, published in March 2018 by the Medical Device Coordination Group.

Medical device- and drug manufacturers may experience a lack of language clarity and consistency in the coming years. They may also experience a lack of language clarity and consistency when procuring language services through vendors without industry-consolidated terminology sources. When multilingual regulatory terminologies and national requirements are unavailable, manufacturers can benefit from establishing their own language terminologies and glossaries specific to their product portfolio. A global language services provider can help establish, maintain, and optimize usage of such language assets.

Get in touch 

Need assistance with your translations for medical device development, drug authorizations, or post-approval of your medicinal drugs or devices? Lionbridge has decades of experience providing expert pharmaceutical regulatory translation services and medical device language services. Reach out today to discuss our regulatory translation services for pharma and medical device companies.