In Life Sciences, gaining access to the European market is no longer only about innovation, clinical evidence and manufacturing capacity. With MDR and IVDR now firmly embedded, the linguistic dimension has become a real part of regulatory compliance. And this is not about cultural diversity; it is about what the regulations—and national authorities—require: that the information accompanying a medical device is understandable to those who use it and oversee it in each country. This is a market access issue. If that information is not available in the languages required by each Member State, launch timelines slip—or the launch is blocked altogether.
Put simply, if the label, instructions for use and other accompanying information are not available in the languages required in the Member State where the device is marketed, you may face delays, additional requests or, in the worst case, be kept out of the market until the issue is corrected. That is why translation should not be treated as a final “nice-to-have”, but as a controlled process with a direct impact on timelines, costs and regulatory risk.
The key is not “24 languages”, but the languages of your target markets
It is common to see messages along the lines of “everything needs translating into the EU’s 24 official languages”. In practice, the right approach is different. MDR and IVDR allow each country to decide which language or languages are required for the information that accompanies the device. That means the linguistic scope depends on your go-to-market strategy and the national requirements that apply.
This creates a critical planning point: languages are not chosen at the end of the project—they are decided when you define your market footprint. Expanding into five countries might mean two or three languages, or five or more, depending on local combinations and requirements. That is why it helps to work with a country-by-country language map showing, at a minimum, what is required for labelling and IFUs, and any relevant national specifics.
In some markets, requirements are more straightforward. In Ireland, the European Commission’s language requirements table indicates that documentation may be accepted in English, or in English and Irish, depending on the case; in other words, Irish (Gaelic) is not always mandatory if you operate in English. In Malta, the usual rule is Maltese and/or English, so English alone is often sufficient. This does not remove the need to confirm the exact requirement for your product and distribution channel, but it shows why “24 languages” can be an oversimplification that inflates costs and complicates timelines without adding real value.
Beyond the IFU: the document ecosystem
Under MDR and IVDR, what needs translating goes far beyond the instructions for use. It is more useful to think in terms of an ecosystem of content: some texts are critical for placing the product on the market, while others are critical for scaling internationally without creating inconsistencies.
The first group directly affects safe use and market access: labelling, instructions for use (IFUs), safety warnings, symbols and packaging information. This is usually the main focus of language requirements—and the area most exposed to issues if there are ambiguities or terminology errors.
The second group is linked to transparency and safety. Under MDR, certain devices require a Summary of Safety and Clinical Performance (SSCP). Under IVDR, certain in vitro diagnostic devices require a Summary of Safety and Performance (SSP). While the required languages can vary depending on the case and publication route, many organisations manage these documents with a multilingual approach aligned to their sales markets, because they are often cross-checked against the label and IFU and reviewed very closely.
The third group is less visible, but essential for avoiding commercial friction: training content (internal and user-facing), support materials, software documentation and user interface text when the product is digital, as well as content linked to vigilance and post-market follow-up. Not all of this is always translated because it is mandatory, but it is often translated for consistency and risk reduction. If the IFU says one thing and the interface or quick-start guide says another, the problem is not just stylistic—it affects use, support and sometimes safety.
There are also particularly sensitive cases. For implantable devices, the patient implant card and associated information need to be exceptionally clear. For in vitro diagnostics, instructions that influence clinical decisions or result interpretation require impeccable terminological precision—even when the text looks “fine” at first glance.
Linguistic quality: consistency, change control and traceability
In regulated industries, the question is not only “Is it well translated?” The real question is: “Can we show it is controlled?” This is where many organisations shift from a tactical approach (one-off translations) to a system approach, with clear ownership, repeatable criteria and evidence that can be presented during an audit.
There is an important nuance: that system only works if it is delivered by a highly qualified native linguist. It is not enough to have someone who “translates well”. You need specialists with experience in medical devices and regulated documentation—people who can read for context, spot ambiguities, apply standardised terminology and keep consistency across documents and versions. In practice, the specialist linguist becomes a control point, catching linguistic risks before they turn into market issues or expensive correction loops.
When validated terminology and reusable translation memories are combined with a review process with clear roles (linguistic review, technical review where appropriate, and consistency checks for critical elements) and solid change control to ensure updates are applied consistently across all languages, the impact is commercial as well as regulatory: fewer discrepancies between label, IFU and support materials, faster updates and more predictable costs. Translation stops being a reactive cost and becomes an operational capability that accelerates international rollout.
The real timeline: why it pays to plan before the final year
Focusing only on the final deadline is tempting, but it oversimplifies reality. MDR includes staggered transitional timelines, with milestones that may fall in 2026, 2027 or 2028 depending on the device type and the conditions that apply. IVDR also follows a phased timeline, which can extend to 2027, 2028 or even 2029 depending on the IVD class, alongside intermediate obligations that push organisations to act earlier.
From a business perspective, leaving everything to the last minute often creates a bottleneck: regulatory closure coincides with product updates, documentation renewals and peak demand for specialist reviewers. Translating at scale under pressure increases the risk of inconsistencies, late-stage fixes and rework—exactly when timelines are hardest to renegotiate.
A more robust approach is to organise translation in manageable blocks: by product families, variants and priority markets. This supports staggered launches and updates, maximises reuse of translation memories and glossaries, and avoids last-minute emergencies that tend to be costly.
AI and machine translation: efficiency, yes—but with governance
AI can be a powerful ally when you need to manage volume, but not every approach is suitable in a regulated environment. Using generic tools without control creates obvious risks: confidentiality, lack of traceability and inconsistent outputs from one version to the next.
The sensible approach is to treat AI as part of the process, not a replacement for the process. When machine translation is paired with expert post-editing, the objective is to move faster without losing control: keeping a record of source content, what changes were made, how terminology decisions were handled and what the final approved output is. In this setting, post-editing is not about polishing style—it is about technical accuracy, cross-document consistency and suitability for safe use.
We implement what we call a Managed AI Workflow, based on ISO 18587. This standard for machine translation with expert human review makes it possible to handle large volumes and tight budgets without sacrificing the traceability regulators expect. In Life Sciences, AI must be controlled, documented and overseen by specialists who understand the clinical context—so that technological efficiency translates into regulatory compliance.
Towards a more deliberate internationalisation strategy
Success in the European market in the post-MDR/IVDR era does not depend only on having a strong device. It also depends on your ability to communicate its use and the information that accompanies it in the languages each market requires, with consistency and auditability.
The useful question is not “Do we translate into 24 languages?” The useful question is: have we mapped, country by country, which texts must be available in which language, with what level of control, and with what maintenance plan when the product changes?
If the answer is “more or less”, it is the perfect moment to make language management a stable part of your Quality Management System—and, just as importantly, of your internationalisation strategy.
