Understanding EU MDR Translation Requirements: A Guide For Medical Device Companies

What is the EU Medical Device Regulation (MDR)?

The EU MDR (2017/745/EU) is a set of guidelines that govern the production and distribution of Medical devices in EU member states. Introduced in May 2021, the new regulation replaced the medical device directive (MDD), as it couldn’t address the evolving scope of medical devices' compliance in the modern industry. 

Unlike the MDD, the EU MDR introduced stricter requirements for product testing, post-market surveillance, and documentation. One such is the EU MDR language requirement which mandates certain documents be translated into the language of the member state where the Medtech device will be used. Its goal is to ensure that devices meet safety standards and are fit for use by consumers in intended locations. 

What are the EU MDR language requirements for manufacturers?

The EU MDR mandates that manufacturers translate documents into the official languages of each EU member state where their medical devices are marketed. This requirement is part of the EU MDR requirements,  Article 41 which states, 

"All documents required pursuant to Articles 38 and 39 shall be drawn up in a language or languages, which shall be determined by the Member State concerned.” 

This requirement spreads across different sessions, stating that documents, assets, and other medical device documents, such as instructions for use (IFU), must meet the language requirement. 

In all cases, you must deliver these documents in the official languages of the intended member states. However, some states have multiple official languages. In those situations, you must translate your medical device documents into all languages or as stated in the EU MDR language requirement for the manufacturer's table.

Why are accurate translations critical under EU MDR?

Beyond making your application process seamless, you need accurate medical device document translations for the following reasons.

Patient safety

Poorly translated documents can lead to misinterpretation, incorrect usage, or patient harm. For example, if critical safety warnings are mistranslated or omitted, incorrect usage of a medical device could potentially result in harm. 

Regulatory compliance

Accurate translation is a mandatory requirement for getting MDR compliance. If your document doesn't meet the language translation requirements, it will lead to product recalls, fines, or loss of certification.

Market access

Ensuring accurate translations helps establish trust and credibility with healthcare providers and regulatory bodies. When all documentation is clear and compliant with the EU MDR language requirement from the outset, manufacturers can expedite the approval process and reduce time-to-market for their devices. 

With a competitive market like the Medtech industry, time to market is crucial to business success, and seamless compliance ensures faster market access in the intended EU member states. 

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What documents require EU MDR translation?

Under EU MDR, you must translate the following document into the languages of member states where the products will be marketed.

MDR IFU requirements 

The IFU must be translated into the official languages of the member states where the medical device will be sold. This ensures that end-users, including patients and healthcare professionals, can understand how to use the device safely and effectively.

MDR labelling requirements

The MDR labelling requirements mandate translations of labels on the device and its packaging into the relevant languages. These labels can include single-unit packaging, sales packaging, and transport packaging in case of specific management conditions.

Technical documentation

Comprehensive technical files, which include detailed descriptions of the device's design, manufacturing processes, and performance data, must be accurately translated. This documentation is vital for regulatory authorities during the evaluation process.

Clinical evaluations and reports  

Clinical evaluation reports that present data on the device's safety and performance need to be translated so that regulatory authorities and healthcare professionals can assess the device effectively across different languages.

Field safety notices (FSNs)  

In cases of safety corrective actions, FSNs must be provided in the member state's official language(s) where the action is taken. This ensures that critical safety information reaches all relevant stakeholders promptly.

Declaration of conformity (DoC)

While there is some flexibility regarding the translation of the DoC, it still needs to be available in a language accepted by the member state where the device will be marketed. Many countries accept it in English or their national language.

Summary of safety and clinical performance (SSCP) 

For specific devices, particularly those classified as high-risk, the SSCP must be available in all required languages to ensure that patients and users can access important safety information.

What are the challenges of meeting EU MDR translation requirements?

Translating medical device documentation for compliance with the European Union Medical Device Regulation (EU MDR) presents several significant challenges

Technical accuracy vs. clarity  

One of the challenges with medical device document translation is achieving a balance between technical accuracy and clarity. Medical devices' documentation often uses technical and complex terms that must be translated precisely without losing their intended meaning. This creates a challenge for you if your team doesn’t have the experience to translate these documents across multiple languages. 

Pro tip: You need a professional or certified translation service with knowledge of both medical terminology and the specific devices being translated. This approach ensures quality translation uniformity in tone, terminology, and formatting across multiple translations.

Meeting tight deadlines 

The EU MDR requires extensive documentation, including clinical evaluations, technical files, labelling, and instructions for use (IFUs). These documents must be translated into the official languages of the EU member states where the devices will be marketed. 

For example, if your product will be used in Belgium and Finland, you must translate documents into French, Dutch, German, Finnish, and Swedish. This requirement increases the volume of translation work and can be challenging when you are on a tight deadline.  

Regulatory compliance and updates  

The MDR regulations are constantly being updated to meet new requirements or policies. Manufacturers are responsible for staying updated with local language requirements and regulatory changes across different member states. The lack of harmonisation in language requirements among EU countries adds complexity to the process.

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How to get professional certified translations for medical documentation

Obtaining professional certified translations for medical documentation is crucial for compliance with regulatory standards and ensuring accurate communication in healthcare settings. Here’s a step-by-step guide on how to secure these translations:

1. Identify your translation needs 

Determine the specific documents that require translation

2. Choose a reputable certified translation service 

Select a translation service that specialises in medical translations. To ensure accuracy, look for providers with certified translators with relevant qualifications and expertise in the medical field and quality assurance process.

3. Verify certification and compliance  

Ensure that they offer certified translations necessary for legal and regulatory purposes. Also, confirm their certification and accreditation in a reputable association like the EU Association of Translation Companies.

4. Request a quote and timeline  

Contact the certified translation service to request a quote based on the volume and complexity of your documents. Also, confirm if they offer options for expedited services if needed.

5. Submit your documents 

Provide the documents that need translation in an accessible format (PDF, Word, etc.). Ensure that all necessary information is included to facilitate an accurate translation.

6. Review the translated document  

Once you receive the translated document, review it for accuracy and clarity. If possible, have it checked by a bilingual expert in the medical field to ensure it meets your requirements.

Why should you choose Translayte for EU MDR compliance?

Translayte is a leading provider of certified translation to clients globally with a 4.6 over 5-star rating on Trustpilot from over, 7000 satisfied clients. Here’s why you should choose us to translate your EU MDR documents 

• Expertise: Our translators are trained in diverse industries, terminology and languages, ensuring accuracy and compliance.
• Quality assurance: We follow a rigorous translation process involving multiple proofreading and edits to ensure that the final delivery conveys correct information
• Fast turnaround: We deliver high-quality translations within tight deadlines to meet regulatory timelines.
• Confidentiality: We implement strict NDA’s and the latest encryption to ensure all information remains confidential.

Conclusion

The EU MDR language requirements improve the safety of medical devices but also create a challenge. Manufacturers must meet language translations, which is time-consuming and expensive. However, working with certified translation services streamlines this process, ensuring accurate documentation while enhancing patient safety and market access across EU member states. 

Ready to meet EU MDR translation requirements? Order certified translation from Translayte today, tailored to your needs.

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