Medical Device Translation
Expert translation for EU MDR/IVDR compliance and global market access.
Global Market Access for Medical Devices
Medical device manufacturers face complex regulatory requirements. The EU MDR and IVDR mandate documentation in the official languages of each member state.
Our specialized translators understand technical requirements, regulatory terminology, and formatting standards.
Beyond regulatory submissions, accurate device translation protects patients and reduces post-market risk. Mistranslated instructions for use, software interfaces, or warning labels can trigger field safety corrective actions, customs holds, and Notified Body queries. We build a device-specific terminology base, apply translation memory across your product family, and route every file through independent revision so your IFUs, labeling, and technical documentation stay consistent from first submission through every label update.
Medical Device Documents We Translate
Comprehensive translation for all device documentation.
User Documentation
- Instructions for Use (IFUs)
- User Manuals
- Quick Start Guides
- Service Manuals
- Training Materials
Device Labeling
- Primary Device Labels
- Secondary Packaging
- UDI Labels
- Warning Labels
- Sterility Labels
Technical Documentation
- Clinical Evaluation Reports
- Risk Management Files
- Technical Specifications
- Post-Market Surveillance
- SSCP Summaries
Regulatory Compliance
Translations meet requirements of major medical device regulations.
EU MDR (2017/745)
Medical Device Regulation for EU member states.
- All 24 EU official languages
- Annex I General Safety requirements
- UDI-DI labeling compliance
EU IVDR (2017/746)
In Vitro Diagnostic Regulation.
- IVD-specific terminology
- Performance evaluation reports
- Class A-D documentation
FDA Requirements
US FDA device submissions.
- 510(k) submissions
- PMA documentation
- QSR compliance
Other Markets
Global regulatory requirements.
- Japan PMDA / MHLW
- China NMPA
- Health Canada / MDSAP
What You Receive
Every medical device project includes complete, submission-ready files engineered for EU MDR/IVDR and global market access.
Translated IFUs & Labeling
Instructions for use, labels, and packaging copy translated into the official languages of each target market, formatted to match your source layout.
EU MDR/IVDR-Ready Files
Deliverables structured for Notified Body review and member-state requirements, so your technical documentation clears submission without rework.
Terminology Database
A device-specific glossary and translation memory that keep terminology consistent across your full product family and future label updates.
Declaration of Accuracy & Audit Trail
A signed statement of translation accuracy plus a complete audit trail documenting every linguist, revision, and approval step.
Frequently Asked Questions
Which EU languages are required for device labeling?
EU MDR requires documentation in the official languages of each member state where the device is marketed.
Do you translate clinical evaluation reports?
Yes, we translate CERs and other technical documentation for EU MDR compliance.
Can you handle IFU updates?
Yes, we maintain translation memories for consistency between versions.
What is your turnaround for IFU translation?
5-7 business days standard, expedited services available.
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