Medical translation services in 225+ languages

The Medical Device Regulation (EU) 2017/745 has been in force since 26 May 2021 and sets strict requirements for medical device documentation. For each EU member state where a device is placed on the market, Instructions for Use (IFU), labelling and patient-facing communications must be delivered in the local language(s). We work with pharmaceutical specialist translators with regulatory-affairs experience; all language versions are centrally managed for terminological consistency and version-traceability for notified body audits. Similar requirements apply under IVDR (in vitro diagnostics) — Regulation (EU) 2017/746. For UK-marketed devices, equivalent requirements apply under UK MDR 2002 (as amended) overseen by the MHRA.

Medical documents containing patient data fall under Article 9 GDPR (special categories of personal data). We apply a higher standard of care: encrypted file exchange, NDA standard on every project, individual confidentiality agreements with our translators, and a GDPR-aligned DPA on request. For highly sensitive records we work with anonymised source material where feasible. Documents are archived after project completion per our data-retention policy.

The European Medicines Agency (EMA) publishes Product Information templates for the Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labelling. Our pharmaceutical specialist translators work with these templates and validate PIL readability against the EMA 'Readability of the label and package leaflet' guideline. For decentralised procedures we deliver all required EU language versions as a coherent set with shared terminology. For UK national registration via MHRA we work with the equivalent UK SmPC and PIL conventions.

We respond within 1 hour on working days to rush enquiries. For EMA submissions we work with multiple translators in parallel per language pair where needed, with a lead reviser for terminological consistency. We make no fixed 24-hour delivery promise; we communicate transparently about what is feasible based on document volume, number of languages, availability of regulatory-affairs-experienced translators and your submission window. Weekend deployment is available for clinical deadlines.

Our rates align with market standards for medical-pharmaceutical translation. Indicative £0.12–£0.24 per word, depending on language combination, complexity (pharmacology/regulatory affairs at the upper end) and deadline. For recurring clients we use translation memory which yields 20–40% savings on repeating segments — particularly relevant for PILs and IFUs with cumulative product versions. Volume discounts are available for clinical trials with multiple language pairs.

We translate medical documents in more than 225 languages. For MDR/IVDR compliance within the EU we cover all 24 EU languages plus Norwegian and Icelandic. For clinical trials we work with pharmaceutical specialist translators per therapeutic area (oncology, cardiology, neurology, etc.). For rare languages — often relevant for immigration-related patient records — we recommend a longer planning window due to availability of a medical specialist translator.

For patient information, PILs and regulatory submissions we do not use unreviewed machine translation — patient safety and regulatory compliance require human specialist editing. We use DeepL Pro, OpenAI and Anthropic as productivity aids for draft translation, followed by full post-editing and revision by a medical specialist. For less critical documents — internal research notes, summaries — MTPE (machine translation with post-editing) can be an efficient route.