FÜD
Specialised translation › Medical devices
Medical device translation — MDR / IVDR compliant.
Medical device translation for the official languages of your target markets: instructions for use (IFU), labelling and technical documentation — handled by professional translators with a medical-technology background. MDR/IVDR compliant, terminology-checked and confidential.
- MDR & IVDRcompliant translation
- ISO 13485 settingQMS-ready
- IFU & labellinglabels & manuals
- 4.6 · Trustpilot
Professional translators for medical technology · compliant with the MDR (2017/745) and IVDR (2017/746) · IFU and labelling in the official languages of your target markets · terminology aligned to the product file
In short
For a medical device, translation is part of market approval.
Without a correct language version, a medical device cannot be placed on the market. The MDR (2017/745) and the IVDR (2017/746) require the instructions for use (IFU), labelling and safety-relevant information to be available in the official languages of each member state — accurate, consistent and traceable. That is why at the FÜD your device documents are translated by professional translators with a medical-technology background.
We secure terminology through glossaries, translation memories and recognised references, and deliver with the same structure in your formats. As a special case of our medical translation, medical device translation draws on medical and technical knowledge at once — closely related to our technical documentation.
Document types
What we translate for medical devices.
Use
- Instructions for use (IFU)
- Operating manuals
- Safety instructions
Labelling
- Labelling & labels
- Packaging texts
- Symbols & UDI references
Technical file
- Technical documentation
- Conformity documents
- Software interfaces (SaMD)
Market & users
- Patient information
- Training material
- Websites & catalogues
Document & regulation
Which document, which regulation — and which language obligation.
For medical devices, translation is part of market approval. Here is an overview of the governing regulations — the exact scope depends on the device class and the target markets.
| Document | Regulation / standard | Language & translation obligation |
|---|---|---|
| Instructions for use (IFU) | MDR 2017/745, IVDR 2017/746 | in the national language(s) of the target member states |
| Labelling | MDR/IVDR, Annex I | symbols, warnings and UDI carried over consistently |
| Clinical evaluation / performance evaluation | MDR/IVDR | specialist terminology, EUDAMED-compliant data fields |
| Risk management / technical file | ISO 14971 | consistent terminology across the entire dossier |
| Process & quality assurance | DIN EN ISO 17100 (Reg. 7U517) | professional translator + revision, strict confidentiality |
Why language is mandatory
For a CE-marked device, the national language is not optional.
The MDR requires labelling and instructions for use in the languages each member state sets for its own territory. Anyone placing a device on the market across Europe therefore does not translate once — but into many official languages at the same time.
In Germany that language is German (Medical Devices Act Implementation Act, MPDG). The instructions for use and medicinal-product information follow their own language rules too.
Where medical device translations fail
Eight pitfalls that turn a translation into a compliance or liability risk.
Not every mistake shows on first reading — the most expensive ones surface only in an audit, in a vigilance case or at market entry. These are the eight we specifically check against for medical devices.
| Pitfall | Why it gets expensive | How the FÜD safeguards it |
|---|---|---|
| Not all destination-country languages covered | If the official language of a destination country is missing, the device cannot be placed on the market there — distribution can be halted. | At the start of the project we clarify the target markets and derive from them the mandatory languages for the IFU and labelling. |
| Intended purpose imprecise | The intended purpose governs classification and the liability framework; a differing wording effectively changes the device. | We translate the intended purpose, indications and contraindications against the product file with no drift and reconcile them under the four-eyes principle. |
| Warnings and safety notices weakened | A shifted modal verb ("must not" → "should not") reduces the warning effect and gives grounds for product liability. | Safety and warning notices are translated word-faithfully by professional translators with regulatory experience, with no shift in meaning. |
| Standardised symbols treated as running text | EN ISO 15223-1 replaces text with symbols — if these are wrongly "translated", duplications and review non-conformities arise. | We carry standardised symbols as references per EN ISO 15223-1 and translate only the permitted accompanying texts. |
| UDI / EUDAMED data fields inconsistent | If designations differ between label, IFU and EUDAMED, traceability of the UDI breaks down. | We keep UDI references and EUDAMED-relevant fields consistent and structurally identical across languages. |
| Terminology without a glossary/reference | Inconsistent designations across languages and variants count as a documentation defect in an audit. | A glossary, translation memory and reference terminologies (MedDRA, EDQM Standard Terms, EMDN) secure one designation per term. |
| SSCP and IFU drift apart | If the summary (SSCP) and the instructions for use diverge in content, the EUDAMED publication becomes challengeable. | We check every language version of the SSCP and IFU against the same source and keep them terminologically in sync. |
| Layout / eIFU break on transfer | With eIFU or DTP, structure, cross-references and symbol positions are lost — reviewability drops. | We deliver with the same structure in your formats (incl. eIFU per 2021/2226); layout, references and citations are preserved. |
The common thread: a mistranslation is not a language error but a compliance error.
For medical devices, the language version is part of the technical documentation. That is why we check not only whether a sentence "sounds right", but whether the intended purpose, warnings, symbols and UDI references stay identical across the instructions for use, labelling and SSCP.
One warning unclear — and the device cannot be placed on the market.
That is why: medical-technology professional translators, MDR/IVDR grounding and checked terminology.
Specialist perspective
How we turn language into compliance.
Three levels of control interlock on every medical device project — so a translation holds not only linguistically but in regulatory terms.
Four-eyes principle per ISO 17100
Every translation is revised by a second qualified person — safety-critical passages such as warnings are additionally checked by a specialist. Process DIN EN ISO 17100, certified (Reg. 7U517).
Terminology & references
Product-specific glossaries, translation memory and recognised reference terminologies — MedDRA (vigilance terms), EDQM Standard Terms and the EMDN nomenclature for EUDAMED. One designation per term, across all languages and variants.
Regulatory review
On request, a person with MDR/IVDR experience checks the intended purpose, warnings and labelling against the requirements — before release, not first in the audit.
Confidentiality & back-translation.
Unpublished technical details are processed for the agreed purpose only, in line with the GDPR — on request under an NDA and entirely without machine translation or AI. For clinical evaluation, performance evaluation and approval we offer back-translation and reconciliation where required.
From practice
Three typical projects — and what the FÜD delivers in concrete terms.
The scope differs by device class and target market. These are the three constellations we meet most often.
IFU for EU market entry
An active Class IIb device is placed on the market in several EU countries at once — the instructions for use must be in every mandatory official language.
- IFU and labelling in all required official languages
- Intended purpose & warnings word-faithful, four-eyes revision
- Glossary & TM as a basis for follow-up versions
Product information for an IVD
An in-vitro diagnostic device with a performance evaluation and laboratory-medicine terminology is to be made available in an IVDR-compliant way.
- Instructions/product information and labels under the IVDR (2017/746)
- EUDAMED-compliant data fields, consistent UDI references
- laboratory-medicine terminology uniform across languages
Software as a medical device
With medical software the interface is itself the medical device — menus and messages are part of the intended purpose.
- UI strings, menus and messages translated to fit the available length
- Warnings and error messages word-faithful, with no shift in meaning
- Consistency between UI, online help and the instructions for use
Quote & price
Individually calculated, bindingly committed.
The price depends on volume, target markets (official languages), format and terminology needs. After a review we name a binding fixed price — with fixed terms for ongoing product maintenance.
| Professional translation (medical technology) | ✓included |
| Terminology & references | ✓included |
| Format / labelling handling | ✓included |
| Four-eyes check | ✓included |
As a guide, translations start from € 0.89 per standard line (55 characters incl. spaces); we name the exact amount after a brief review. How the price is made up →
FAQ
Medical device translation — frequently asked questions.
Which languages do medical devices have to be translated into?
Do you translate in an MDR/IVDR-compliant way?
Who translates the instructions for use (IFU)?
Can you handle labelling and UDI references?
Do you offer back-translation for studies and approval?
Do technical details stay confidential?
How do you translate the intended purpose?
Do you also translate the software interfaces of medical devices (SaMD)?
Next
Where to go next: services, fields, documents and languages.
EUDAMED & electronic IFU
SSCP, EUDAMED and the electronic instructions for use.
Beyond the IFU and labelling, the MDR requires — for implantable and Class III devices — the summary of safety and clinical performance (SSCP) in the official languages of the target markets; it is made accessible through the EU database EUDAMED. Every language version must be identical in content and terminology-checked.
Regulation (EU) 2021/2226 permits electronic instructions for use (eIFU) for certain devices — with the same language obligations as the printed document. We translate them together with the instructions for use, adjacent chemicals and pharmaceuticals documentation and the rest of our medical professional translation.