Milestone’s guide on

LANGUAGE TRANSLATION REQUIREMENTS OF MEDICAL DEVICE REGULATION

 

A free and comprehensive guide to help you seamlessly navigate the new language requirements as per the European Medical Device Regulation.

eu mdr language requirements

What’s inside our guide on EU MDR language requirements? 

EU MDR and updated timelines

Key Changes in the EU MDR

Responsibility of the medical device manufacturer regarding translation

Language requirements outlined in the EU MDR

Languages accepted in the EU member states

How to approach language compliance as per EU MDR

EU MDR-compliant medical device translations 

If you are looking for a reliable translation partner who can provide EU MDR-compliant medical device translations, look no further!

We are an ISO 17100:2015 – certified translation agency and our translation services are available in over 70+ languages, done by experienced native translators with domain expertise.

We provide high-quality translations for all types of documents related to medical devices, along with translation certificates accepted by regulatory authorities across the globe.

Instructions for Use (IFUs)

Medical device labels and packaging

Medical device operation manuals

Technical documents

Summary of Safety and Clinical Evaluation Reports

Standard Operating Procedures and quality manuals

Clinical trial documentation and more

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SaaS Localization Checklist