Medical device translations - English German translator for MDR and IVDR documents

Professional translation › Medical devices

German translators for medical devices — MDR, IVDR and labelling

A UK, US, Irish, Australian or Canadian device maker cannot place a product on the German, Austrian or Swiss market without German-language IFU, labelling and — for implants — an SSCP: MDR/IVDR and Switzerland's MepV make the national language a market-access precondition, not a nice-to-have.

MDR & IVDRcompliant translation
ISO 13485 settingQMS-ready
IFU & labellinglabels & manuals
4.7 · Trustpilot

Get your device documents translated Document types

Professional German translators for medical technology · English ⇄ German, both directions · compliant with the MDR (2017/745) and IVDR (2017/746) · terminology aligned to the product file

DIN EN ISO 17100certified · Reg. 7U517

German and Englishnative-speaker professional translators

Price up fronttransparently calculated

ConfidentialGDPR-compliant · NDA available

Medical Device translation

No German IFU, no market access — language belongs to the approval file.

Reviewed by specialists · termbase editorial team

Without a correct language version, a medical device cannot be placed on the market — in either direction: English to German for the German-speaking market, German to English for export. The MDR (2017/745) and the IVDR (2017/746) require the IFU, labelling and safety-relevant information in the official languages of each member state — accurate, consistent and traceable. That is why at termbase your device documents are translated by professional German translators with a medical-technology background — alongside our medical translation and chemical & pharmaceutical work.

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.

Documents we translate into German

Which device documents we handle: IFU, labelling, technical file.

In use: instructions for use, operating manuals, safety notices

Instructions for use (IFU)
Operating manuals
Safety instructions

Labelling, packaging texts, symbols and UDI references

Labelling & labels
Packaging texts
Symbols & UDI references

Technical file: conformity documents and SaMD interfaces

Technical documentation
Conformity documents
Software interfaces (SaMD)

For market and users: patient information, training material

Patient information
Training material
Websites & catalogues

Document & regulation

Document, regulation, language duty: MDR 2017/745, IVDR, ISO 14971.

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

24 EU languages, 27 national rules — and the MPDG requirement for German.

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.

24official EU languages — potentially relevant for labelling & instructions for use

27member states, each setting its own language requirements for its territory

2017/745MDR, Annex I Ch. III (23.1 & 23.4): information in the designated language(s)

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: intended purpose, warnings, EN ISO 15223-1 symbols, UDI.

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 termbase 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 mistranslated IFU is a compliance defect, not a style slip.

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.

Why German — and what decides it

Language as market access: MDR Art. 10(11), the MepV and the SSCP.

Art. 10(11) & Annex I §23 MDR 2017/745

Member-state language rule — English alone does not suffice

MDR (and IVDR Art. 10) require IFU, labelling and safety info in the official language(s) each Member State sets — Germany and Austria both require German, English alone does not suffice.

Art. 51 & Art. 20 MepV (Switzerland)

Swiss CH-REP and the implant card in three official languages

Since the EU-CH MRA lapsed May 2021, every non-Swiss manufacturer (EU-based included) needs a Swiss CH-REP; implant cards must be in German, French AND Italian, per the Ordinance text itself.

Art. 32 MDR — SSCP / EUDAMED

SSCP in the local language before EUDAMED publication

For Class III and implantable devices, the Summary of Safety and Clinical Performance must be published in EUDAMED in the local language before the device may be distributed in that market.

One warning unclear, and the device cannot be placed on the market — the notified body reads the translation.

Two decades. Millions of translated words of regulatory device documentation. A network of German ⇄ English specialists that device makers and notified bodies trust to place products on the market in Germany, Austria and Switzerland.

Specialist German translators

Three controls: four-eyes revision, reference terminology, regulatory review.

Three levels of control interlock on every medical device project — so a translation holds not only linguistically but in regulatory terms.

Four-eyes revision to DIN EN ISO 17100 (Reg. 7U517)

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: MedDRA, EDQM Standard Terms and EMDN for EUDAMED

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 of intended purpose, warnings and labelling

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, NDA and back-translation for clinical evaluation

Unpublished technical details are processed for the agreed purpose only, in line with the GDPR — on request under an NDA, always with qualified human specialists. For clinical evaluation, performance evaluation and approval we offer back-translation and reconciliation where required.

From practice

Three device projects: a Class IIb IFU, an IVD, software as a device.

The scope differs by device class and target market. These are the three constellations we meet most often.

Class IIb · IFU

Class IIb instructions for use across several EU markets

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

IVDR · IVD

IVD product information under the IVDR (2017/746)

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

SaMD · UI

Software as a medical device: UI strings, messages, online help

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

What a German translation costs

Target markets, volume and format set the price — quoted as a fixed sum.

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.

Binding fixed price

from A$1.45per standard line · professional translation

everything included

Professional translation (medical technology)	✓included
Terminology & references	✓included
Format / labelling handling	✓included
Four-eyes check	✓included

As a guide, translations start from A$1.45 per standard line (55 characters incl. spaces); we name the exact amount after a brief review. How the price is made up →

Request a quote

FAQ

What device makers and regulatory affairs teams ask us first.

Which languages do medical devices have to be translated into?

The MDR and IVDR require the instructions for use, labelling and safety-relevant information in the official languages of the member states in which the device is made available. We translate into the target languages you need.

Do you translate in an MDR/IVDR-compliant way?

Yes. We take account of the MDR (2017/745) and IVDR (2017/746) requirements on comprehensibility and traceability and work with recognised reference terminologies and your glossaries.

Which translators produce the instructions for use (IFU)?

Professional translators with a medical-technology background who combine medical and technical knowledge; on request a second qualified person reviews the text under the four-eyes principle.

Can you handle labelling, symbols and UDI references?

Yes. Labelling, labels, symbols and accompanying texts are translated with the same structure and consistent terminology; layout and references are preserved.

Do you offer back-translation for studies and approval?

Yes. For clinical evaluations and regulatory documentation we offer back-translation and reconciliation where required.

Do unpublished technical details stay confidential?

Yes. Unpublished details are processed for the agreed purpose only, in line with the GDPR; on request under an NDA, always with qualified human specialists.

How do you translate the intended purpose?

The intended purpose is relevant to classification and liability. We translate it against the product file with no drift and reconcile it under the four-eyes principle, so no shift in meaning arises.

Do you also translate the software interfaces of medical devices (SaMD)?

Yes. Menus, messages and warnings are translated to fit the available length and kept consistent with the instructions for use and the online help.

We had budgeted to translate the complete technical documentation. What actually carries a language duty is a much shorter list — labelling, instructions for use, the implant card, the safety and clinical performance summary — and for Switzerland the implant card in all three official languages. Knowing which was which changed the size of the project.

★★★★★

Ramesh Pillai · regulatory affairs manager, Singapore · IFU, labelling and implant card

Adjacent work: pharmaceutical, medical report and certified record translation.

By document

German translator for official documents Marriage certificate German translation Birth certificate translation into German Police certificate translation into German

By field

Professional German translation Chemical translation into German German text translation German book translator

Also translated

German diploma translation Certified German company document translation Official German divorce translation

By service

German certified translation service Professional German translation agency Certified German legal document translation Certified German medical report translation

EUDAMED & electronic IFU

The SSCP in EUDAMED and the eIFU under Regulation (EU) 2021/2226.

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.

Upload document Get a price