Introduction

The European Union Medical Device Regulation (MDR) adopted in April 2017, changed the European legal framework for medical devices and introduced new principal and supportive responsibilities for EMA and for national authorities in the assessment of certain categories of medical products.

The aim of the MDR is to ensure patient safety and provide greater transparency and traceability of medical devices throughout their lifecycles. Specifically, MDR was enacted to ensure a high standard of safety and quality for medical devices that are produced or supplied to member countries of the European Union.

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

With MDR, any medical device marketed in an EU country must be accompanied by clear labeling and instructions in the local language.  IVDR also contains language saying that the translated content must be accurate and easy to understand, including for non-medical professionals.  What is most important to understand is that MDR covers much more than just ensuring that content exists in the required languages where the device is marketed. MDR rules set clear standards for the accuracy, clarity, and accessibility of that content, and meeting these standards is not a one-time effort, but an on-going process.

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 has taken on a greater urgency.  There is a direct impact on market access, if the languages required by each EU are not included in the translated material.  Non-compliance to the regulation means that the manufacturer cannot sell their medical devices within the relevant EU country.

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.