The European Union Medical Device Regulation (EU MDR) is a critical framework that governs the safety, performance, and marketing of medical devices within the EU. Officially known as Regulation (EU) 2017/745, the MDR replaced the previous Medical Device Directive (MDD) in May 2021. One of the regulation’s key aspects—often underestimated in scope and complexity—is the requirement for accurate translation.
What is the EU MDR?
The EU MDR was adopted to modernize and strengthen the regulatory framework for medical devices in the European market. Its main objectives include:
Ensuring high standards of quality and safety for medical devices.
Increasing transparency and traceability through tools like the EUDAMED database and Unique DeviceIdentification (UDI). The European Database on Medical Devices (EUDAMED) is a system developed by the European Commission to implement the Medical Device Regulation (MDR) and In Vitro Diagnostic DeviceRegulation (IVDR). It serves as a central platform for information and data exchange on medical devices within the European Union.
Enhancing post-market surveillance and clinical evaluation requirements.
Tightening controls on notified bodies and conformity assessments.
The MDR applies to all medical device manufacturers who wish to market their products in the EU, regardless of where the medical device companies are based.
Why is Translation Important Under the EU MDR?
Unlike the MDD, the EU MDR places a much stronger emphasis on linguistic accessibility. Since the EU comprises 27 member states, each with its own official language(s), providing device information in the appropriate local language is crucial for:
Patient safety
Regulatory compliance
Market access
User comprehension (for both healthcare professionals and lay users)
Medical Device Translation Requirements Under EU MDR
For medical device manufacturers seeking to enter or maintain presence in the European market, translation is fundamental to EU MDR compliance. The EU MDR demands precise, accurate translations of numerous documents to ensure patient safety and market access.
Technical documentation, labelling, and user instructions must be translated into the official languages of EU member states in which the devices are to be marketed. Under the EU MDR, this specialised translation process ensures that all relevant documentation communicates information clearly and accurately in each target language and that it complies with regulatory terminology.
The regulatory terminology for the EU MDR includes a specific set of terms that are legally defined in the regulation itself, primarily in Article 2 – Definitions. These terms are essential for manufacturers, regulators, notified bodies and translators to understand and use correctly, especially when drafting or translating documentation.
Written material that must be translated and compliant with the EU MDRincludes:
1. Labelling and Instructions for Use (IFU)
Under Annex I, Chapter III of the MDR, manufacturers must ensure that labels, packaging, and instructions for use are available in the official language(s) of the Member State where the device is marketed. Clear and appropriate language must be used.
2. Technical Documentation and Design Dossier
Information regarding device design, manufacturing processes and risk assessments must be translated.
3. Summary of Safety and Clinical Performance (SSCP)
For Class III and implantable devices, the SSCP must be made publicly available via EUDAMED and translated into the languages accepted by the relevant member states.
4. Post-Market Surveillance (PMS) Documents
Reports such as the Periodic Safety Update Report (PSUR) and Post-Market Clinical Follow-up (PMCF) evaluations may require translation when submitted to national authorities.
5. Vigilance Reports
Field Safety Notices (FSNs) must be translated to ensure healthcare providers and patients understand the issue and any corrective action needed.
6. UDI and EUDAMED Submissions
Although the UDI itself is alphanumeric, associated descriptions in EUDAMED may require medical device translation depending on the regulatory authority’s language requirements.
7. Declaration of conformity
This is an official document that confirms regulatory compliance and must be available in the required languages.The inappropriate or inaccurate translation of these documents may result in significant legal and financial consequences. These could include delays in access to the market, product recalls, safety issues and regulatory rejection.
Who Is Responsible for Translation?
The manufacturer of the devices holds ultimate responsibility for ensuring that all required documentation is correctly translated. Translations are assessed for both linguistic accuracy and alignment with regulatory terminology. Manufacturers will usually rely on professional medical device translation providers who are experienced with the technical, legal, and linguistic nuances of MDR documentation. Machine translation without expert post-editing is not advisable, as errors can lead to non-compliance or patient safety risks.
Best Practices for EU MDR Tr anslation Compliance
There are 27 EU member states and 24 official languages. For this reason, EU MDR Translation Compliance is a complex undertaking. The work demands the expertise of professional, specialist translators that boast the knowledgeand ability to manage projects effectively.
Best practices are as follows:
Manufacturers should plan for translation requirements when scheduling production and release.
The writers of the original documentation related to medical devices should be mindful of the need for translation into multiple languages and of the regulatory terminology.
Translators must have detailed knowledge of:
EU MDR specific terminology and requirements
Medical device technical specifications and terminology
Clinical evaluation reporting standards
The evolving regulatory framework
Translators should use official EU language versions as references when translating regulatory content.Translationsmust be consistent with terms defined in Article 2 of the MDR. Translators should refer to MDCG (Medical DeviceCoordination Group) guidance documents for clarified or evolving usage and should check whether the Member State concerned has additional local definitions or interpretations in their national laws or guidance.
Consistency is paramount and so translators should utilise translation memories and terminology databases to ensure uniformity. All translated material should be reviewed and validated preferably by experts in the subject matter who are native speakers.
The importance of translation to EU MDR compliance
The EU MDR's translation requirements are more than a formality—they are central to device safety, user understanding, and regulatory success. Manufacturers must approach medical device translation  strategically to ensure timely market access and continued regulatory compliance in one of the world’s largest medical device markets. The expertise of specialist translators is key to achieving compliance, maintaining compliance and bringing devices to market in a timely fashion.
