Medical device manufacturers entering or expanding in the European market face a specific translation challenge: every IFU, label, SSCP, and regulatory submission must meet the language requirements of EU MDR 2017/745 — in the official language of every member state where the device is distributed.
Link Translation provides medical device translation services built specifically for this regulatory environment. Our translators hold domain credentials in medical devices, our In-Country Review process satisfies ISO 17100 and ISO 13485 quality requirements, and our workflow is structured to produce documentation that integrates directly into your technical file and EUDAMED registration.
Why Medical Device Translation Services Require Regulatory Expertise
Medical device documentation is not general content. IFUs contain dosage information, contraindications, procedural sequences, and safety warnings that directly affect patient outcomes. A translation error in an IFU for an implantable device can lead to incorrect surgical procedures. A mistranslated label on a diagnostic device can produce misdiagnosis.
EU MDR Article 10 requires that IFUs be provided in a language easily understood by the intended user. For consumer devices, that means the official language of the member state. Notified bodies reviewing technical files routinely flag translations that fail this standard — and a failed IFU translation can delay or block CE marking certification.
Why Manufacturers Choose Link Translation
How Our Medical Device Translation Process Works
1. Assessment & Scoping
We begin with a complete review of your device portfolio, target markets, and existing translation assets. We identify gaps, assess translation memory recovery potential, and deliver a prioritized project plan with timeline and cost within 48 hours.
2. Translation by Domain Experts
Every medical device project is assigned to translators with verified credentials in the relevant clinical domain. We use CAT tools with controlled terminology databases to ensure consistency across your documentation portfolio.
3. In-Country Review & Validation
Each translation undergoes review by a native-speaking specialist with medical device industry experience. The reviewer validates clinical accuracy, terminological consistency, and regulatory language compliance.
4. Delivery & Technical File Integration
Final documentation is formatted for direct insertion into your technical file and EUDAMED registration package. We maintain all source files, translation memories, and glossaries for efficient future updates.