Regulatory translation allows a medical device to be accepted in the market where it will be sold
For a medical device manufacturer, translation is not a closing communication step: it is a compliance requirement. Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) require certain information to accompany the product in the official language of each Member State where it is made available. That makes translation part of the technical file — and subjects it to the same demands of traceability and control as the rest of the regulatory documentation. It is, in practice, technical translation carrying an added regulatory burden.
At GT-Traduções we have worked with technical and clinical documentation for four decades. We translate for manufacturers, distributors and authorised representatives, with translators native in the target language and proven practice in the sector.
Are you placing a device in new EU markets?
We review the document set and the required languages, and propose a translation circuit with glossary, version control and technical validation.
Contact our teamThe documentation we translate for manufacturers
- Instructions for use (IFU) and labelling — the information accompanying the product, which the user or healthcare professional must understand without ambiguity.
- Clinical trial and clinical investigation documentation — protocols, investigator brochures, consent forms and reports.
- Post-market surveillance — periodic reports, incident notifications and field safety corrective actions.
- Clinical evaluation and risk management — documentation supporting the technical file.
- Technical and maintenance manuals — installation, calibration and servicing of the equipment.
- Technical training materials — content for professionals who use or install the device.
- Declarations and correspondence with notified bodies — where the certification process requires it.
How we handle regulatory documentation
Manufacturer-approved glossary
We fix the product terminology before translating and submit it for approval. The glossary is what ensures the same component is named the same way across every language and every version.
Version control
Each revision of the source document produces a traceable update in the target languages. When the original changes, we know precisely what must be retranslated and what stands.
Technical validation
Revision is carried out by a second professional with domain knowledge, and the manufacturer may bring its own in-country reviewer into the circuit before final approval.
Need consistency across languages and across versions?
We establish the glossary, the review circuit and the version history before work begins — so the documentation can grow without losing coherence.
Request a quote WhatsAppThe types of project we handle
IFU and labelling for the Portuguese market
Instructions for use and labelling for an imported device, with terminology aligned to the technical documentation already in place.
Clinical investigation file
Protocol, consent forms and reports prepared in three languages, with a fixed glossary and version control maintained throughout the study.
Post-market surveillance
Incident notification and field safety corrective action, translated to short deadlines with terminology matching the technical file.
Why entrust it to GT-Traduções
Since 1986 we have translated technical and clinical documentation, from our office in Loulé.
Each project goes to translators with practice in medical devices, always working into their own native language.
Translation, independent revision and terminology checking before delivery.
We are members of the Chartered Institute of Linguists, under a demanding professional code.
Product documentation and study data handled within a restricted circuit, under confidentiality agreements.
English, French, Spanish, German, Italian, Dutch and Polish, among other combinations.
Frequently asked questions
What information must be translated under the MDR and the IVDR?
The regulations require the information accompanying the device to be made available in the official language of each Member State where the product is placed. The exact scope depends on the risk class and the market, and should be confirmed with the notified body or the competent authority.
How do you keep versions of the same document consistent?
Through an approved glossary and version control. When the source is revised, we identify what has changed and update only those passages, leaving the remaining text stable across languages.
Can our in-country reviewer take part in the process?
Yes. We bring the manufacturer’s or distributor’s reviewer into the circuit before final approval, and incorporate their decisions into the glossary for subsequent translations.
Does regulatory documentation require certified translation?
Not always. Certification is required in specific formal procedures and before certain bodies. We confirm with you, document by document, what is required before proceeding.
Can you meet short deadlines for post-market surveillance?
Yes. For incident notifications and field safety corrective actions we agree an urgent circuit in advance, with defined turnaround times and terminology already fixed.
Is this technical translation or certified translation?
It is technical translation: regulatory documentation, instructions for use, labelling and manuals handled by professionals with practice in the sector, with an approved glossary and version control. Certification only comes into play where a formal procedure requires it, and in that case we arrange both.
We support your device’s multilingual documentation
Tell us the document set, the required languages and the expected timeline, and we will put forward a proposal with glossary, review circuit and version control. Office in Loulé, serving the whole of the Algarve and the country.
Request a quoteor call +351 934 602 625 · [email protected]
