Translation into Irish in the healthcare sector: what you need to know

Amid international growth and European regulatory requirements (such as Regulation (EU) 2017/745 on medical devices), many companies, particularly those operating in the medical sector, must ensure that all their documentation is available in the official languages of the countries where they intend to market their products. If you are considering expanding into the Irish market, translating into Irish can be both a regulatory requirement and a strategic advantage.

Irish: linguistic and cultural context

Irish (Gaeilge), or Irish Gaelic, is a language spoken in Ireland. It is part of the Goidelic branch of the Celtic language family, within the Indo-European group. Alongside English, Irish is the official language of the Republic of Ireland and has also been an official language of the European Union since 2007.

While English is spoken by virtually the entire population of Ireland and serves as the dominant language in daily life, according to the Irish Central Statistics Office, around 40 % of the population can speak Irish to some degree, demonstrating that the language retains cultural importance and legal recognition within the country. It is present in education, the media, and official documents. Its value as a symbol of identity, along with its role in public administration, make it a relevant language for companies seeking to enter the Irish market.

Did you know that historically, the term Gaeltacht, which means ‘Gaelic-speaking community’, has been used to refer to Gaelic-speaking areas in both Ireland and Scotland? Over time, its use has been restricted to designate the regions where the Irish language is still predominant.

Differences with English: implications for translation

Although they coexist, English and Irish are radically different in terms of grammar, vocabulary, and culture. The table below shows the most relevant aspects:

Furthermore, literal translation between the two languages is unfeasible: many expressions, technical terms, and structures need to be completely reformulated to sound natural and correct in Irish.

Did you know that before also adopting the Latin alphabet, the Irish language used the Old Gaelic alphabet, which consisted of only 18 letters?

Today, the remaining letters of the Latin alphabet are mainly used for borrowed words or scientific terms.

What is the legal and regulatory situation regarding Regulations (EU) 2017/745 and 2017/746?

The medical sector is highly important and, for that reason, heavily regulated, as is the field of translation. In fact, the relationship between the medical device sector and the translation sector is primarily governed by the articles of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR).

What does European law say?

Article 10, paragraph 11 of Regulation (EU) 2017/745 states that:

“Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.”

What does Irish law say?

According to Irish law S.I. No. 547/2017 - European Union (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017, which implements the EU Regulation mentioned above, it is not mandatory to translate medical device documentation into Irish:

“For the purposes of […] the language determined by the State is the English language or both the Irish language and the English language.”

In fact, this is also stated in the MDR’s explanatory table on language requirements, which you can find here.

In short:

• Is it mandatory to provide the documentation translated into Irish? No.
• Does this mean that it is sufficient to provide the documentation in English? Yes.

In that case, why is translating into Irish an advantage?

Although English is sufficient from a regulatory point of view, translating into Irish can be a strategic tool in various scenarios. Providing health or product information in Irish:

• Demonstrates cultural respect and commitment to the country.
• Boosts the company’s image with local authorities and consumers.
• Facilitates access to public markets, as it can become a competitive advantage over other companies that only communicate in English.
• Increases inclusion and trust among native speakers, and conveys respect for the local culture.

Did you know that in 2017 the tradition of Irish bagpipe playing, known in Irish as píob uilleann, was added to UNESCO’s Representative List of the Intangible Cultural Heritage of Humanity?

What a company should know when ordering a translation into Irish

If you need to translate documents into Irish, make sure that the translation agency:

• Works with native translators
• Applies the criteria of accurate technical terminology, especially in regulated sectors
• Is familiar with the official language conventions
• Delivers adapted versions and not literal translations

Conclusion

Irish is not merely ornamental: it is an official language with legal, cultural, and regulatory weight. For companies seeking to operate professionally and effectively in Ireland, having Irish-language versions of their documentation sets them apart. But remember, for the translation of documentation related to medical devices, translating into Irish is not mandatory.

Do you want to comply with the regulations, gain credibility, and expand your market? Place your trust in a specialised agency. At AbroadLink, we can help you meet the requirements.

References

Central Statistics Office. (2022). Irish Language and the Gaeltacht. https://www.cso.ie/en/releasesandpublications/ep/p-cpp8/censusofpopulation2022profile8-theirishlanguageandeducation/irishlanguageandthegaeltacht/

European Parliament and Council of the European Union. (2017). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Official Journal of the European Union, L 117, 1–175). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745

Government of Ireland. (2017, December 8). European Union (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017 (S.I. No. 547/2017). Irish Statute Book. https://www.irishstatutebook.ie/eli/2017/si/547/made/en/print

European Commission, Directorate-General for Health and Food Safety. (2025, August 18). MDR – language requirements for manufacturers (Rev. 3). https://health.ec.europa.eu/document/download/aa9760e3-c864-4173-8b16-d790dac66d74_en?filename=md_sector_lang-req-table-mdr.pdf