What are the requirements for medical device translations?

When it comes to translating documentation and materials related to medical devices, precision and expertise are paramount. This intricate process demands accuracy and compliance with regulations, as errors or inaccuracies can have severe consequences.
By adhering to the requirements outlined below, we can ensure high-quality translations that align with current regulations, contributing to the safety and well-being of patients worldwide.

Requirements for Medical Device Translation

• Industry Knowledge and Specific Terminology: Translators must possess in-depth knowledge of the medical industry and its terminology. This ensures accurate translation of technical terms while preserving the original meaning in all its nuances.
• Regulatory Compliance: Medical devices are subject to stringent regulations in many countries. Translations must adhere to the laws and regulations of the target country. This may involve compliance with ISO standards like ISO 13485, which focuses on quality management systems for medical devices.
• Quality Control Process: A rigorous quality control process is crucial to ensure translation accuracy. It includes multiple reviews by medical field experts and verification by native speakers of the target language.
• Localisation: Beyond literal translation, cultural and regional differences must be taken into account. Localisation involves adapting content to be culturally appropriate and easily understandable for the target audience.
• Confidentiality and Data Security: Medical device documentation often contains sensitive information. Translators must prioritise confidentiality and maintain data security.
• Documentation and Traceability: Accurate documentation of the translation process, including change records, revisions, and approvals, is essential. Traceability ensures regulatory compliance and can be invaluable during audits or inspections.

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Documents to be Translated

The European Union's Medical Device Regulation (MDR), effective as of May 2021, introduced stringent rules for translating medical devices. According to the MDR, all materials related to medical devices, including manuals, instructions for use, labels, and safety information, must be translated into the official languages of EU countries where the device will be marketed.
Translating medical devices with accurate information is crucial. But that's not all. In addition to these documents, translating informed consents, clinical reports, and marketing documentation may be necessary for effective communication with patients and stakeholders in other countries.

Why Choose Eurotrad?

Accurate and clear translations of medical devices are vital for ensuring patient and healthcare professional safety and efficacy. The MDR underscores the significance of precise and comprehensible translations, requiring organisations to implement stringent quality control processes to verify accuracy.
Non-compliance with the MDR's translation regulations may lead to sanctions and product withdrawal from the market. It is therefore essential for medical device manufacturers to be aware of these regulations and collaborate with specialised translators to ensure compliance. Eurotrad guarantees this compliance through our network of native-language translators with expertise in scientific and specialised translation services within the pharmaceutical sector.

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