German medical device translation – MDR-compliant and standard-conforming
Medical device translation by professional translators – across Germany, fixed price from €0.95 per line, quote in around two hours.
Medical device translation: language version as a prerequisite for market access
For medical devices, the language version determines market authorisation: we translate instructions for use, UDI labelling and technical documentation in an MDR-compliant and terminology-faithful way.
For medical devices, language is critical to approval: under the MDR (EU 2017/745) and IVDR (EU 2017/746), instructions for use (IFUs), labelling and accompanying information must be available in the national language of each target country – only then can a product be placed on the market with legal certainty.
We translate IFU, labels, UDI marking, technical documentation and software interfaces securely in terminology across all product variants – in certified processes in accordance with DIN EN ISO 17100 and in the environment of ISO 13485.
Instructions for use and labelling into all official languages of the target markets
Do you translate label and UDI data consistently with the EUDAMED database?
Yes. On the label, the MDR requires, among other things, the manufacturer's details, UDI, product name and warnings (Annex I, Section 23.2). Translated labelling and UDI data must match the EUDAMED entry – an inconsistent UDI is a classic audit finding, which we avoid through coordinated terminology.
How do you ensure instructions for use that are understandable to laypeople?
Depending on the risk class, instructions for use are aimed at professional users or at laypeople. We translate in the appropriate register – technically precise for professional users, clear and comprehensible where patients apply the product themselves – and keep warnings uniform across all language versions.
Do your processes meet ISO 13485 and ISO 17100?
We translate in certified processes in accordance with DIN EN ISO 17100 and in the environment of an ISO 13485 quality management system. Many Notified Bodies expect manufacturers to have their translations produced by service providers that are professional in medical devices and certified to ISO 17100 – this is exactly the profile we bring.
Approval-ready for the Notified Body, quality management and software as a medical device
What does the notified body require, and in which language?
For products in higher risk classes, the Notified Body assesses the documents as part of the conformity assessment; they must be available in an official language of the respective country or in English. We deliver technical documentation, test reports and conformity documents consistently and ready for submission.
Do you translate software as a medical device and user interfaces?
Yes. For software as a medical device, we keep terminology consistent across the software life cycle (IEC 62304) – from the user interface to the accompanying documentation, fitting the available space and length. We handle in-vitro diagnostics accordingly under the IVDR.
How your medical device translation works
Enquiry and upload
Send us your documents as a PDF, photo or scan – we review the scope, field and intended use.
Fixed price in 120 minutes
You receive a binding fixed-price quote with a delivery date, clearly calculated in advance.
Professional translators and revision
Assignment to professional translators with a relevant background; independent four-eyes revision in accordance with DIN EN ISO 17100.
Delivery digital and by post
Digital advance version and, on request, the hard copy by post – on schedule.
Medical device translation: German, English, French, Turkish, Spanish, Polish and over 60 languages
We produce medical device translations in German, English, French, Spanish, Italian and over 60 further languages – MDR-compliant and understandable to laypeople where the IFU requires it.
How your fixed price for a medical device translation is calculated
We bill transparently by standard line (55 characters including spaces) from €0.95. The binding fixed price depends on volume, field, language combination and the desired quality level – with no hidden costs and usually within about two hours. View prices and sample calculations.
Medical device translation – frequently asked questions
What does a medical device translation cost?
From €0.95 per standard line; the binding fixed price depends on volume, field, language combination and quality level, and usually reaches you within about two hours.
Do you translate in an MDR-compliant way?
For medical devices, the MDR (EU 2017/745) requires linguistically correct, layperson-comprehensible information. We translate instructions for use (IFU), UDI labelling and conformity documents accordingly.
Do you take IEC 62304 into account for software?
Yes. For software as a medical device we keep the terminology consistent across the software life cycle (IEC 62304), including the UI and accompanying documentation.
How do you ensure consistent terminology?
Through subject-matter glossaries and translation memory, with consistent units and warnings across all language versions and product variants.
How fast do you deliver?
As a rule a few working days; for urgent jobs by express. You usually receive the fixed-price quote within about two hours.
Medical devices in accordance with MDR and IEC 62304
For medical devices, the MDR (EU 2017/745) requires linguistically correct, layperson-comprehensible information; software as a medical device follows the life cycle of IEC 62304, and every unit carries its UDI. We translate Instructions for use (IFUs), Audit reports, Patent specifications and technical manuals – terminologically reliable and regulatorily accurate.