Fields › Medical & Pharma
Medical translation of doctor's letters, findings, drug information, medical-device instructions for use (MDR) and clinical-trial documents is carried out by subject-matched medical translators, with terminology control and a final review. Clinical-trial documents must be provided in the national language under Regulation (EU) 536/2014; we deliver compliant and confidential. On request the work runs entirely without machine translation or generative AI. From €0.89 per standard line.
Doctor's letters, findings, trial documents and product information · terminology by field and product · MDR/IVDR context considered · certified by an authorised translator on request
Short & clear
A medical translation has to hit terminology, purpose, audience and regulatory context all at once. As a medical translation service we support doctors and patients with findings, diagnoses, doctor's letters, evaluation forms and laboratory reports — and equally manufacturers, pharmaceutical companies and research institutions.
A medical translator is assigned at the FÜD by field, document type, language direction and intended use. Approved terms are stored in glossaries and translation memories and reused consistently later. Every project passes through quality management and a final check; revision, specialist editing or back-translation are added wherever the project needs them.
Typical documents
Doctor's letters, findings and diagnoses for treatment abroad, insurance or a second opinion — confidential and, on request, certified by an authorised translator.
IFU, labelling, GUI and technical documentation to the approved target-market and language matrix — consistent across product lines and releases.
Product information, package leaflet, labelling and pharmacovigilance to the template and terminology applicable to the procedure.
Study protocols, informed-consent forms, questionnaires and publications — with an agreed back-translation and documented reconciliation where required.
Which form do you need?
Not every medical translation has to be certified. Whether a plain professional translation is enough, or an authorised translator has to certify it, is decided solely by the body you submit the document to. This orientation helps you place your case.
you want to understand a foreign-language finding for yourself or the treating team; a clinic or doctor abroad needs the content for onward treatment but asks for no certification; it is a matter of a second opinion, research or internal documentation; or you are having publications, trial documents or specialist literature translated.
an authority, insurer, health fund or court officially requests it; you submit documents to a foreign authority or embassy — for reimbursement, a pension or an insurance benefit; a recognition, pension or care procedure requires the official version; or an apostille is additionally required for use abroad — issued by the competent authority, not by the FÜD.
The required form is always set by the receiving body. Tell us the document, target country and recipient — the FÜD checks in advance whether a certified translation or an additional apostille is needed, and delivers at a fixed price including dispatch.
One wrong dose — and the package leaflet becomes a risk.
So: specialist medical translators, checked terminology and a final control on every project.
Regulatory
For medical devices, the required language version depends on the target market and the type of information. The European Commission publishes country-by-country MDR and IVDR tables for this — including for information in graphical user interfaces. The FÜD transfers the approved source documentation into the language matrix defined by the client and keeps IFU, labelling, GUI terms and safety-relevant notes consistent across versions.
For centrally authorised human medicinal products, the EMA provides QRD templates for the product information, labelling and package leaflet. Version 10.4 is the published operative template kept up to date; version 11 remains a draft following the completed consultation. The FÜD works with the template approved for the specific procedure, applies agreed reference terminology and documents changes between language versions.
| Information / document type | Governing regime | Language logic | Primary source |
|---|---|---|---|
| Instructions for use (IFU), labelling, implant card | MDR (EU) 2017/745 | official language(s) of the target Member State — the Commission maintains an MDR language table per country | European Commission, MDR language table |
| IVD labelling & instructions for use | IVDR (EU) 2017/746 | per Member State; the Commission has its own IVDR language table | European Commission, IVDR language table |
| Graphical user interface (GUI / software) | no specific MDR/IVDR article | governed nationally — individual countries have their own GUI requirements | European Commission (GUI note) |
| SmPC, labelling, package leaflet (centrally authorised human medicine) | Medicines · EMA QRD | all EU official languages; per QRD template (kept up to date: v10.4) | EMA, QRD templates |
For centrally authorised human medicines, the EMA provides the product information via QRD templates in 26 language versions — the 24 EU official languages plus Icelandic and Norwegian (EEA). The FÜD staffs every language direction by field and keeps terminology and standard wording consistent across all versions.
Certification & recognition
For submission to insurers, authorities, clinics or a court, medical documents such as a doctor's letter, finding or medical certificate often have to be presented as a certified translation. A court-authorised translator (in German, ermächtigter Übersetzer, publicly authorised under German state law) produces it with stamp, signature and a certification note — at a fixed price including dispatch.
We clarify in advance which form the requesting body needs, and whether an apostille is additionally required for use abroad. The apostille itself is issued by the competent authority — the FÜD does not issue apostilles. The work follows the DIN EN ISO 17100 process, and on request the FÜD handles the project entirely without machine translation and generative AI, keeping final responsibility with qualified humans.
Use cases
Document type, purpose and target market decide the terminology, the form of certification and the review scope. Three common jobs — from the starting point to the result.
Clinic & insurance
Medical devices · MDR
CRO & research
Quote & price
We review volume, field, language direction, regulatory requirements and the scope of checks and name a binding fixed price. Each medical project is different; for recurring needs we set fixed conditions in a framework agreement.
| Specialist medical translation | ✓included |
| Terminology & reference material | ✓included |
| Quality management & final check | ✓included |
| Certification by an authorised translator on request | ✓included |
| Additional review (revision or back-translation) | +optional |
Medical professional translation 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
Precise, on time, with genuine medical expertise — exactly what we needed for our marketing-authorisation dossier. The terminology stayed consistent across every language version.
Dr. A. Klein · Regulatory Affairs, SKL Pharma
Next
Work with us
Medicine and pharma are among the fields where language alone is not enough. To take on findings, product information or trial documents you need a proven medical or pharmaceutical field, control of its terminology, and — for certified work — a court-authorised sworn translator. We work continually with specialist medical translators, employed or freelance.
The path
A degree in translation is the start; in medicine the market rewards depth. A field you can defend — a clinical specialty, regulatory affairs, medical devices, pharmacology — is the real gate, because a finding, an SmPC or an IFU only reads correctly when the terminology is right. That command of the subject, not language alone, is what a clinic, a notified body or a regulator actually relies on.
Why it holds up
For certified translations you apply to the competent Regional Court (Landgericht) to be authorised under state law. And medicine is a case where careless automation is a liability: a wrong dose in a leaflet, a mistranslated safety note, an inconsistent term across an approval dossier. Careful human work here is not nostalgia — it is what the receiving body requires.
FÜD
