Precise specialised translation for regulated content
Translations for medical technology
IFU, labelling and regulatory documents translated with precision, consistency and full auditability.
ISO 17100 · ISO 18587 · ISO 9001 · four-eyes principle · NDA practice
Translations for medical technology are safety- and compliance-critical: They impact user safety, regulatory compliance and market access. COMLOGOS supports manufacturers and suppliers with specialised translation that combines linguistic precision, consistent terminology and audit-ready processes, tailored to regulated technical content and the requirements of international markets.
The conditions are demanding: The MDR defines language requirements for each target country. For IFU, labelling and warnings, the tolerance for errors is extremely low, and both auditors and customers expect clearly documented, traceable processes. In addition, terminology needs to remain consistent across product generations, from the first regulatory submission dossier through to the current device revision. Our knowledge page provides an overview of linguistic obligations, deadlines and a robust, audit‑proof process. MDR/IVDR-compliant translation.
Even minor linguistic inaccuracies can cause misunderstandings, incorrect use or nonconformities during an audit. This is why we work with structured processes, centralised terminology management and multi-stage quality assurance that includes targeted review of critical content: Warnings, figures and units are checked separately.
Request a project & get advice
Do you have technical documents that need translating? Please send us 1–2 sample files. You will receive a specific recommendation and a quote within 24 hours.
Medical technology translation that stands up to audits
From IFU to regulatory dossier, in line with ISO 17100 processes, with MedTech specialist translators and audit-ready quality assurance. See for yourself first with a free sample translation.
Three value promises
Compliance-focused security
IFU, labelling and warning notices have an immediate impact on safe use. Critical content (warnings, dosage and measurement information, figures and units) is checked in a targeted way. Every translation undergoes the four-eyes principle in accordance with ISO 17100.
Audit readiness
Defined, ISO-certified processes, documented QA checks, version control and change management: Every translation step can be demonstrated during audits, both for Notified Bodies and within supplier audits carried out by your customers.
Terminology across product generations
A central terminology database and the translation memory ensure consistency from the regulatory submission dossier through to the current device revision. With updates, only the new content is translated. The verified content is preserved exactly as it is, word for word.
The two worlds
Medical technology speaks two languages: that of devices and that of software. Although both are subject to the same regulatory framework, they place different demands on documentation and translation. That's why we treat them separately, but bring them together in one coordinated process.
World 1
Devices and Hardware
- Product range: Diagnostic and imaging systems, implants, laboratory equipment and point-of-care systems.
- Instructions for use: The IFU is the central safety-relevant document and must be clearly worded and regulatory compliant in the official language of each target market.
- Labelling and marking: Product labelling and packaging texts and labels are terminologically consistent and adhere to the linguistic requirements of each target market.
- Clinical and technical: Clinical evaluations and study documentation (ISO 14155), as well as technical documentation, must be written in precise and consistent specialist language.
World 2
Software and Digital Health
- SaMD: Software as a Medical Device and digital health applications, software lifecycle in accordance with IEC 62304, usability in accordance with IEC 62366-1.
- User interfaces: UI text, online help and system descriptions, consistent with device documentation, with attention to character limits and context.
- eIFU: Electronic Instructions for Use, as defined by Regulation (EU) 2021/2226. These are multilingual, version-controlled and consistent with the paper version.
- AI interface: Where software uses AI, the Medical Device Regulation (MDR) and the EU AI Act intersect, bringing additional transparency and documentation obligations.
Regulations at a glance
Medical technology translation takes place within a closely interwoven framework of EU regulations and standards. The main regulatory frameworks that guide our processes and terminology:
MDR: Regulation (EU) 2017/745
Language requirements for instructions for use, labelling and safety-critical information in each target market.
IVDR: Regulation (EU) 2017/746
Specific regulatory framework for in vitro diagnostic devices; user-friendly instructions for use for tests intended for self-testing.
eIFU: Regulation (EU) 2021/2226
Conditions for electronic instructions for use; the paper IFU and the eIFU must be identical in wording and subject to version control.
IEC 62304
Software lifecycle for medical device software and software as a medical device (SaMD).
IEC 62366-1
Usability engineering: clear and safe user information.
ISO 14155
Clinical investigations with medical devices: Study protocols, subject information and study reports.
ISO 13485
Quality management for medical devices as the basis for auditable, documented processes.
EU AI Act
For AI in medical devices there are additional transparency and documentation obligations (dual regulation with MDR/IVDR).
Status as of July 2026; information without guarantee. The applicable EU regulations and standards and the national language requirements of the target markets are decisive.
These are the documents we translate for you
Languages for your target markets
For IFU and labelling, we provide complete language sets in the official languages of your target markets. They are delivered consistently from a single source and managed in a Translation Memory.
Quality you can rely on
ISO-certified processes
Translation in accordance with ISO 17100 ISO 17100, post-editing in accordance with ISO 18587, quality management in accordance with ISO 9001, defined, documented procedures.
Specialised translators with a MedTech background
Native-speaker linguists with a technical background and experience in regulated, safety-critical content.
Structured QA and terminology assurance
Four-eyes principle (translation and revision), documented QA checks, terminology and consistency checking, targeted review of critical content.
Reliable project management
Version and change management, dedicated contacts and reliable deadlines, even for multilingual projects with short turnaround times.
Related expertise from COMLOGOS
IT & software
SaMD and digital health, software documentation, UI strings and online help, consistently across all releases.
Learn more
Electrical Engineering & Digital Industry
Device electronics, embedded systems and industrial components – the technical foundation of many medical devices.
Learn more
Pharmaceuticals & Chemicals
Combination products: where medicinal products and devices come together, both worlds interlock.
Learn moreThe right services & technologies
Frequently asked questions about translations in medical technology
Which language requirements apply to medical devices in the EU?
The MDR requires that the instructions for use and labelling are available in the official language or languages of the Member State in which the product is made available. Certain countries allow English for products that are used exclusively by professional users. This needs to be verified for each target market. We provide complete language sets for all target markets, consistently using a Translation Memory.
When may instructions for use be provided electronically (eIFU)?
Regulation (EU) 2021/2226 permits electronic instructions for use for defined product groups under specified conditions. Among other things, a paper version must continue to be available upon request. For translation, this means that the eIFU and the paper version must be version-controlled and kept strictly identical and consistent in every language version.
What does the EU AI Act mean for software as a medical device (SaMD)?
AI functionalities in medical devices are subject to dual regulation: In addition to MDR or IVDR, the obligations under the EU AI Act apply. These include transparency, documentation and information obligations, in some cases with language requirements for operating instructions. The application deadlines for embedded high-risk AI are currently under discussion in the EU legislative process. We manage terminology and documents so that updates can be quickly implemented in all language versions.
What makes a translation “audit-ready”?
Traceability at every step: defined processes in accordance with ISO 17100, qualified specialised translators, revision by a second person, documented QA checks, plus version and change management. In audits – both with the Notified Body and in supplier audits – this makes it possible to demonstrate who translated, reviewed and approved what, and when.
How do you ensure consistent terminology across product generations?
At the start of the project, we create a central terminology glossary that is binding for all documents and languages. The Translation Memory then stores every approved translation. For a new device revision or a document update, only the modified content is translated anew. IFU, labelling and software UI speak the same language consistently over many years.
What is distinctive about translations under the IVDR?
Under the IVDR, in vitro diagnostics follow their own specific set of rules, with distinct requirements for classification and performance evaluation. Instructions for use for self-testing kits are particularly sensitive: They must be understandable for laypersons, linguistically precise and at the same time easy to grasp in every target language.
Do you also translate clinical evaluations and study documentation?
Yes. We translate clinical evaluations, investigation plans, subject information sheets and consent forms as well as study reports, in the context of clinical investigations in accordance with ISO 14155, using consistent specialist terminology and documented quality assurance.
How does this page differ from your Pharmaceuticals & Chemicals page?
Here, the focus is on devices, software and their documentation in accordance with MDR and IVDR: IFU, labelling, regulatory documents, SaMD. The Pharmaceuticals & Chemicals page covers active ingredients, substances and processes: Marketing authorisation, GMP, REACH and CLP. For combination products (drug–device combinations), both worlds work closely together. Simply get in touch with us.
What our clients in the pharmaceutical and medical technology sectors say
Regulated, review-required specialised translation, validated by manufacturers from the pharmaceutical and medical technology sectors.
"For many years, we have been relying on COMLOGOS’s competent support for regulatory translations. We particularly value the high quality of the translations, the reliability and the flexibility when working to demanding schedules. The professional and straightforward collaboration gives us confidence that even time-critical projects are completed on schedule and to a high professional standard."
"We are very satisfied with the fast and straightforward processing of our orders and with the friendly and competent support from our team. Our complex medical texts are translated with a high level of professionalism and care. We appreciate the ongoing collaborative partnership with COMLOGOS.
Let’s talk about your MedTech project
Send us 1–3 sample documents, for example an IFU, UI strings or a regulatory dossier. You will receive a well-founded assessment of the effort involved, the process and the terminology development. Confidential, binding, with no detours.
ISO 17100 · ISO 18587 · ISO 9001 · four-eyes principle · NDA practice
