Choose a medical device translation provider that works under ISO 13485 and ISO 17100, uses linguists with medical or engineering expertise, and can turn round urgent safety updates in every market at once. Under EU MDR and IVDR, a translation error in a label or IFU is a compliance risk and a patient safety risk.
Toppan Digital Language (TDL) translates labels, IFUs, software interfaces, safety notices and clinical materials for medical device manufacturers in more than 200 languages. This guide covers what needs translating, what the regulations require, how to compare providers, and what it costs.
What needs translating for a medical device?
Anything a user, patient or regulator in a market needs to read. The biggest volumes are usually labelling and instructions for use, but software and safety communications carry the most time pressure.
| Content | Who reads it | What makes it hard |
|---|---|---|
| Labels and packaging | Users, patients, distributors | Strict space limits; artwork and typesetting in every language |
| Instructions for use (IFUs) and eIFUs | Clinicians, patients, lay users | Consistent terminology across long documents and many versions |
| Software and device interfaces | Clinicians, patients | Text length limits on screens; strings tested in context |
| Field safety notices and safety updates | Users, healthcare providers, authorities | Every market at once, on very short deadlines |
| Clinical materials (patient questionnaires, consent forms) | Trial participants, ethics committees | Linguistic validation for patient-reported outcomes |
| Technical documentation and summaries for regulators | Notified bodies, authorities | Precise technical and regulatory language |
| Training and marketing materials | Sales teams, clinicians | Claims must match the approved labelling |
What do EU MDR and IVDR require for translation?
The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require the information supplied with a device to be in the official language or languages set by each member state where it is sold. Each country decides which languages it accepts, and for whom, so the language list differs by country and by user type.
For translation, that means three things in practice:
- A language list per country: confirm which languages each market requires for lay users and for professional users before you plan the work.
- Translation under quality control: translation is a process your quality management system has to control, so treat your provider as a supplier under ISO 13485, with records of who translated and reviewed what.
- Version control: when the source text changes, every language version must be updated and traceable, which is where translation memory and terminology management matter.
TDL’s article on why medical device translation belongs in your risk management process covers how to treat translation as a risk control.
Which companies offer medical device translation?
Four types of provider offer it. The difference that matters most is whether their process is built for regulated content: certified quality systems, subject-matter linguists and traceable records.
| Provider type | Best for | Watch out for |
|---|---|---|
| Language service providers with a life sciences team and ISO 13485 | Labels, IFUs, software, safety notices and clinical materials across many markets | Check the team really specialises in devices, not just general medical content |
| General translation agencies | Marketing and non-regulated materials | No device-specific quality system or regulatory experience |
| Freelance medical translators | Single languages, small volumes | Hard to scale to 20+ languages at once or to supply quality records |
| Machine translation tools | Internal understanding of documents | Not acceptable on its own for labelling or anything a patient reads |
TDL is in the first group. Its life sciences team works with device manufacturers on labelling and packaging, IFUs, patient information, software and device interfaces, regulatory documentation, clinical materials, training and marketing content, and post-market safety communications, under ISO 13485:2016 and ISO 17100:2015 certification.
How do I choose a medical device translation provider?
Ask every shortlisted provider the same eight questions. The answers show whether their process will stand up to an audit by your notified body.
| Criterion | What to ask | Why it matters | TDL’s answer |
|---|---|---|---|
| Certification | Are you certified to ISO 13485 and ISO 17100? | Shows a quality system built for devices and for translation | ISO 13485:2016 and ISO 17100:2015 certified, plus ISO 9001:2015, ISO 18587:2017, ISO 27001:2022 and HITRUST |
| Linguists | Do translators and reviewers have medical, engineering or regulatory backgrounds? | Device terminology errors can change how a device is used | Dedicated teams of experienced technical and medical device linguists, with independent review and in-country subject-matter review where required |
| In-country review | Can your reviewers work with our in-country affiliates or distributors? | Local reviewers catch market-specific terms and approve faster | Works with your affiliates, internal subject-matter experts or external in-country reviewers |
| Terminology | Do you build and maintain a termbase for our devices? | Keeps terms identical across labels, IFUs and software | Centralised, client-specific termbases and translation memories, built through dedicated terminology work |
| Change management | How do you handle source updates across 20+ languages? | Every version must change together and stay traceable | Translation memory, automated workflows, traceable project records, controlled review steps and client-portal visibility |
| Urgent updates | How fast can you translate a field safety notice into all our languages? | Safety communications can’t wait for a normal schedule | Fast-track options and agreed SLAs for urgent post-market updates |
| Typesetting | Do you lay out labels and IFUs in every language? | Text expands in translation and must still fit the artwork | Multilingual DTP for labels, packaging and IFUs, including complex XML and HTML formats |
| Security | How are unreleased device files and patient data protected? | Product files are confidential; clinical files contain health data | ISO 27001:2022 and HITRUST certified, with encrypted file transfer, MFA, granular permissions and optional onshore workflows |
What is linguistic validation, and when do device makers need it?
Linguistic validation is a structured process that proves a translated patient questionnaire measures the same thing as the original. Device makers need it when clinical investigations or post-market studies use patient-reported outcome measures in more than one language.
The usual steps, following ISPOR good-practice principles:
- Two independent forward translations by native speakers
- Reconciliation into one version
- Back translation into the source language and review against the original
- Review by a clinician or expert in the field
- Cognitive debriefing: interviews with patients in each country to check they understand the questions as intended
- Final proofreading and a report documenting every decision
TDL translates and linguistically validates patient-reported outcomes, informed consent forms and other clinical trial materials. For more detail, see TDL’s guide to linguistic validation in clinical trials.
How much does medical device translation cost, and how long does it take?
Cost depends on word count, the number of languages, the review steps your quality system requires and how much text repeats from earlier versions. TDL scopes each project on these factors rather than a flat rate. The biggest savings come from the process: one global device manufacturer cut its translation costs by 20–30% after TDL introduced a central termbase, workflow automation and machine translation with expert post-editing.
What moves the price:
- Repeat content: IFUs and labels share a lot of text between devices and versions, so translation memory can lower the cost of updates considerably.
- Review level: translation plus independent review is standard; in-country review and back translation add steps.
- Typesetting: laying out labels and IFUs in every language is often a large share of the cost.
- Number of languages: a full EU launch can mean 24 or more languages at once.
- Urgency: same-day or out-of-hours work carries a surcharge.
How fast can a field safety notice be translated?
With a prepared process, within hours rather than days. TDL offers fast-track options and agreed SLAs for urgent post-market updates. Agreeing the process, languages and reviewers before an incident is what makes that speed possible.
Can AI be used for medical device translation?
Yes, as a first draft that qualified linguists review, but not on its own for anything a patient or user reads. The question is whether an undetected error could affect how the device is used.
| Content | AI only | AI + expert review | Human translation |
|---|---|---|---|
| Labels and IFUs | No | Possible, with full review under ISO 18587 | Yes |
| Software interface strings | No | Yes, with in-context testing | For safety-critical messages |
| Field safety notices | No | No | Yes |
| Patient questionnaires (linguistic validation) | No | No | Yes |
| Internal documents and supplier correspondence | Yes, for understanding | Yes | Rarely needed |
ISO 18587 is the standard for post-editing machine translation output by a professional linguist. TDL’s Managed AI service risk-assesses content for patient-safety impact, regulatory requirements and source complexity, then combines translation memory, terminology, machine translation, expert post-editing and quality evaluation. Regulated content only enters an AI-supported workflow after a risk assessment and with the client’s agreement. TDL also explains why managed AI matters for risk in AI translation.
Case study: how TDL reduced translation costs by 20–30% for a global medical device manufacturer
In 2024, TDL delivered 380 translation projects for a global medical device manufacturer across up to 40 languages, saving a week in turnaround and cutting translation costs by 20–30%.
- Client: A global medical device manufacturer selling in more than 100 countries
- Challenge: Complex multilingual labelling, patient information, technical manuals and digital content across up to 40 languages, with inconsistent terminology, manual XML and HTML handling, growing volumes and MDR requirements
- What TDL did: Introduced dedicated linguist teams, in-country review, workflow automation, custom XML and HTML filters, a company-wide termbase built after a terminology workshop, and machine translation with expert post-editing
- Result: 380 projects in 2024, one week saved in turnaround and 20–30% lower translation costs
Preparing a device for new markets? Read our practical guide to medical device global readiness.
FAQ
Which companies offer medical device translation for EU MDR compliance?
Language service providers with a life sciences team, ISO 13485 and ISO 17100 certification, and subject-matter linguists. Toppan Digital Language translates labels, IFUs, software and safety notices for device manufacturers.
What translation solutions help medical device teams keep multilingual documentation compliant?
A provider working under ISO 13485, combined with translation memory, a device termbase and version control, so every language changes together and stays traceable.
Which translation vendors can handle urgent safety updates?
Providers with a fast-track process and service levels agreed before an incident, with languages and reviewers already set up. TDL offers fast-track options and agreed SLAs for urgent post-market updates.
Do I need ISO 13485 and ISO 17100 for IFU translation?
They are not legal requirements for the translator, but they show the provider’s process can be controlled and audited as part of your quality system.
Can machine translation be used for IFUs?
Only as a first draft that a qualified linguist fully post-edits and reviews. It should not be used on its own for anything a patient or user reads.
What is linguistic validation?
A process that proves a translated patient questionnaire measures the same thing as the original, using forward and back translation and interviews with patients.
Talk to TDL’s life sciences team
Planning an MDR update, a new market launch or a safety-notice process? Send us your documents, target markets and deadline, and our medical device team will recommend the right workflow and provide a quote. Contact the team or see medical device translation services.
