Medical document translation

Author: Yuri Vodostoy — Technical translator and founder of Insight Translation · Updated 2026-08-18

HardTrans translates pharmaceutical and clinical documents: SmPCs, package leaflets, trial protocols, consent forms, discharge summaries. It reads the whole job before it translates a word, builds a project brief and a glossary from it, and keeps both loaded through every file, so a term settled on page 3 still holds on page 300. You get the file back in the format you uploaded. $1.50 per 250-word page, first document up to 10 pages free, no signup.

Where medical machine translation actually breaks

Medical document translation fails in two places, and the medicine is not one of them. On our German-to-English run of August 18, 2026, Google Translate was right on contraindications, active substance, serious adverse event, investigator and investigational medicinal product. The failures cluster in the wording a template fixes and in the register a document type dictates. One German word, Nebenwirkungen, has two correct English translations, and which one is right depends on the document you are in.

Section 4.3 makes the same point in a line. Google Translate rendered sonstige Bestandteile as other ingredients, which is the leaflet wording. The SmPC formula reads “or to any of the excipients listed in section 6.1”. HardTrans wrote excipients, hepatic impairment and the medicinal product with no glossary. Google's “the medicine” is not a bad translation, it is in the wrong document.

SmPC section headings are fixed text

Section names in an EU SmPC come from the EMA QRD product-information template (v10.4, 02/2024). A reviewer reads them against that template, so they are looked up, not translated.

Tested: August 2026. Directive 2001/83/EC and the QRD template give 4.2 as Posology and method of administration, and UK SmPCs read the same after Brexit. Dosage and method of administration is legitimate elsewhere, close to the FDA heading and matching the official English of the German Medicines Act, which is what makes it the hardest of the three to catch: it moves a European document into another regulatory system without ever looking wrong. Areas of application is a section heading at no English-language regulator; Authorization holder loses the section name and adds a US spelling.

Without a glossary HardTrans made the same 4.2 mistake and wrote 4.1 Indications rather than Therapeutic indications. Template headings are an invariant of the document, not language knowledge; no engine guesses them reliably, and the panel above took three glossary entries. Two things HardTrans did take on its own: Marketing Authorisation Holder, and the 4.1 formula “is indicated in adults for the treatment of”, where Google slipped into leaflet register with “is used in adults to treat”.

One German word, two English terms

Both English terms below translate Nebenwirkungen. In SmPC section 4.8 the right one is adverse reactions; in the package leaflet for the same product it is side effects.

Tested: August 2026, SmPC section 4.8. The section heading is Undesirable effects, and the QRD template closes the section with the fixed sub-heading Reporting of suspected adverse reactions. Google Translate resolved the German word as the patient-facing term in the first sentence and as the regulatory term two sentences later, inside one section; both highlights on the left mark that single German word, red where the leaflet term landed in an SmPC section, green where the fixed reporting formula carried the correct one. Side effect is not banned from section 4.8, and we found it in 1 of the 52 EMA product-information files we checked, in a table footnote, but it is never the term the section is built on.

The score here runs both ways. Uncommon is the fixed frequency category in the template and Google took it, while HardTrans without a glossary wrote Occasionally, and severity where the template says seriousness. Three entries (Nebenwirkung → adverse reaction, Gelegentlich → Uncommon, Schweregrad → seriousness) closed every slot: “Within each frequency group, adverse reactions are listed in order of decreasing seriousness. Uncommon (≥ 1/1,000 to < 1/100): an increase in liver transaminases was observed. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system.”

Where Google Translate got it right

On three of the seven passages it needed no help. The package leaflet came back almost word for word on the QRD patient formulas, side effects included, and that is the same German word that was in the wrong register two sections earlier. The discharge summary was clean: unremarkable twice, Post cholecystectomy, improved general condition. In section 4.8 it also reformatted the German 1/1.000 as 1/1,000 unprompted. In the consent form it wrote revoke your consent, which is not an error either, since the Clinical Trials Regulation says “by revoking his or her informed consent”. Withdraw is the more frequent form and HardTrans used it. Both are correct, and picking one is house style, which is what a glossary records. An earlier dated run on a German medical passage, from June 2026, sits on our Google Translate vs HardTrans examples page.

Clinical trial translation

Protocol text, consent forms and safety reporting run on defined terms, and the definitions sit in ICH E6(R3) and Regulation (EU) No 536/2014. One protocol sentence cost Google Translate two of them.

Google Translate: “The reference information on safety can be found in the current product information for the investigational medicinal product.”

HardTrans, no glossary: “The reference safety information is to be taken from the current Summary of Product Characteristics (SmPC) of the investigational medicinal product.”

Reference safety information (RSI) is a defined term, not a description: Annex I of Regulation (EU) No 536/2014 requires “a clearly identifiable section called the ‘Reference Safety Information’ (RSI)”, and ICH E6(R3) lists it in the glossary. Google's paraphrase is grammatical and unattested, and it loses the acronym that ties the sentence to expectedness assessment and expedited SUSAR reporting. Fachinformation goes the other way. It is the German name of the SmPC, and the German text of that same Regulation introduces it as the short form of the summary of product characteristics, then uses it where the English writes SmPC. In EU usage product information covers SmPC, labelling and leaflet together, so Google points at a bundle where the protocol points at the one document carrying the RSI.

If trial files reach you as XLIFF out of a CAT tool, the round trip is in our guide to translating XLIFF online.

How to translate a medical report to English

Upload the file and you get the same file type back with the report structure intact. On the German discharge summary both engines produced usable English; HardTrans held the clinical register more tightly, with “right upper quadrant pain of three days' duration”, and it kept the addressee in “into your outpatient care”, which Google dropped.

The limitation is the file, not the language. A scanned report, or a photo of one, has no text layer and we do not support it. There is no OCR on our side. A PDF exported from a hospital system usually does have a text layer and gets translated in place.

Certified medical translation

We do not issue certified or sworn translations, and there is no human editor in our loop. If a court, a registry or an immigration authority requires certification, our output does not meet that requirement however well it reads. What it gives a specialist is a draft to edit rather than retype, with the terminology already consistent across the set. The general case for official documents is on our best AI translator for documents page; this page is the medical half of it.

What it costs

$1.50 per page of 250 words, no subscription and no minimum. The first document up to 10 pages is free, with no signup. Speed comes from 15 multi-file jobs of 100 pages or more, March to July 2026: median 0.34 minutes per page, so a 100-page submission set lands around 34 minutes.

Common questions

Do you provide certified medical translations?

No. We issue no certified or sworn translations, and there is no human editor in the loop. For a court file or an immigration application, our output is the draft a qualified translator certifies, not the certified document.

Can it translate a medical report to English?

Yes, if the file has a text layer. DOCX and text-layer PDF reports come back as the same file type with the layout kept. A scan or a phone photo is not supported, and discharge summaries often are exactly that.

Do you keep my files, and are they used for training?

Files are deleted from our servers automatically after 7 days; until then you can download them again. Your text is never used to train models — neither by us nor by Anthropic, the model provider. Anthropic retains API data for a limited period under its policy and does not train on it.

Which languages?

Any source language into 12 targets, English, German, French, Spanish, Chinese, Japanese and Arabic among them.

Can it handle clinical trial documents?

Yes. Upload the protocol, the consent forms and the safety-reporting text together, so the first pass sees the whole set and settles terms once for all of it. Your sponsor glossary applies across the job; where it is silent, the glossary we build downloads as CSV at the end, so you can check what was locked.

HardTrans output is AI translation. It is not a substitute for professional medical advice, diagnosis or treatment. For anything going into a regulatory submission, have a qualified specialist review the translation before it is filed.

Upload the SmPC section, the protocol or the report you actually need in English. The first 10 pages cost nothing, and there is nothing to sign up for.