Complying With European Medical Device Regulation (MDR) Language Translation Requirements

Introduction

The European Union Medical Device Regulation (MDR) adopted in April 2017, reshaped the legal framework for medical devices and introduced new responsibilities for EMA and national authorities in assessing certain medical products.

MDR’s primary goal is to enhance patient safety while ensuring greater transparency and traceability throughout a device’s lifecycle. It establishes strict safety and quality standards for all medical devices produced or supplied within the European Union, reinforcing compliance and accountability across the industry.

Why Is MDR Important

MDR is the set of regulations that governs the production and distribution of medical devices in Europe.  The regulation is devised to improve the safety and performance of medical devices in Europe, which in turn provide protection to patients and other users of these medical devices. 

According to Advisara, the MDR comes with several benefits for both patients and manufacturers:

1) Firstly, it ensures a higher level of patient safety by enforcing stricter regulations on medical devices.

2) Secondly, it promotes greater transparency and traceability of medical devices throughout their lifecycles, which helps in identifying and addressing any potential safety issues or recalls.

3) Thirdly, it enhances the overall quality and reliability of medical devices available in the European market.

With MDR taking effect, compliance is mandatory for medical device companies that want to market or sell their products in the 27 EU member countries.

Documents Requiring Translation

All documents relating to medical devices need to comply with MDR:

1) Labels must come with instructions for use (IFU).

2) Technical documents need to include a description, specifications, verification and validation.

It is important to note that MDR states that all medical device documents must be translated into the official language of each EU member state where they are marketed. This rule applies to everything from brochures and catalogues, and any other marketing collateral relevant to the device’s understanding and usage.

Country-Specific Requirements

For easy reference, the European Commission Directorate-General for Health and Food Safety published a table of all European Union country and their MDR language requirements, by type of content.

Accuracy, Clarity And Accessibility

Under MDR, any medical device sold in an EU country must include clear labeling and instructions in the local language. Similarly, IVDR requires translations to be accurate and easy to understand, even for non-medical professionals.

More importantly, MDR goes beyond just language inclusion—it sets strict standards for accuracy, clarity, and accessibility. Compliance isn’t a one-time task but an ongoing process that ensures medical content remains precise, up to date, and fully aligned with regulatory expectations.

Translation Best Practices

The two tried-and-verified steps when translating any medical documents, but especially those that need to comply with IVDR, is to utilize professional translators, combined with a quality assurance process that also maintains a high degree of consistency.

Follow these three key value drivers, for each of your translating projects:

1) A focus on medical accuracy:  only utilize scientific experts, as they will be performing translations of highly technical content.

2) A team of subject matter experts: Make sure that your translators are well-versed with your specific subject matter.

3) A strategy of risk mitigation:  always combine the best-in-class quality processes, with the expertise of industry-expert quality assurance personnel overseeing every translation.

Conclusion

With the advent of MDR, accurate translations have become more critical than ever. Market access depends on including the required languages for each EU country. Non-compliance prevents manufacturers from selling medical devices in the respective markets, making precise, regulation-compliant translations essential.

By prioritizing high-quality translations that are compliant with MDR, device manufacturers are not only ensuring patient safety, but successful and timely market accessibility for their products in the EU.

Language Scientific is uniquely qualified to handle MDR translation requirements.

• Check out this short video  to learn more about our translating expertise.
  
• Contact Us so we can help you become MDR compliant.