MDR Translation Compliance Checklist
Planning Your MDR Translation Compliance
The EU Medical Device Regulation (MDR) requires manufacturers to provide documentation in the official language of each member state where their device is sold. For many companies, this means translating technical documentation, Instructions for Use (IFUs), labelling, and marketing materials into multiple European languages – all while maintaining consistency and regulatory compliance.
Our free MDR translation compliance checklist helps you plan and track this process across a 12-month timeline. Based on our 25 years of experience supporting medical device manufacturers with MDR translation requirements, we’ve broken the journey into four manageable phases: Assessment, Preparation, Implementation, and Finalisation.
Use the interactive checklist below to:
- Track your progress through each phase of MDR translation planning
- Save your checklist and return to it at any time
- Record key project details like target languages, stakeholders, and deadlines
- Download a personalised PDF to share with your team
Whether you’re approaching MDR translation for the first time or updating existing documentation to meet the regulation’s stricter requirements, this tool will help you stay organised and on track.
MDR Translation Compliance Checklist
Your 12-month planning timeline for MDR translation compliance
Phase 1: Assessment
Months 1-3Focus on gathering data and understanding the scope of work. A thorough assessment now will prevent costly surprises later. Consider both immediate needs and long-term maintenance requirements.
Documentation Audit
Budget Planning
Save Your Progress
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