Regulatory Requirements for Medical Translations in Different Countries

If the medical device has a large display screen, the eIFU may be delivered via the device’s display. However, for devices lacking a display, such as implantable devices, the manufacturer may make the eIFU available on their website. As global regulations and requirements are constantly changing worldwide, Argos Multilingual and Global Simple suggest that you do your own validation of the requirements outlined above to ensure that they have not changed. Because the legislation enacted in these countries mostly refers to the GSPR section on the information to be supplied by the manufacturer, it implicitly covers both labels and IFUs.

Medical Device Translation FAQs

• The EU MDR requires extensive documentation, including clinical evaluations, technical files, labelling, and instructions for use (IFUs).
• These translations must be precise to meet the local regulatory standards and ensure device safety.
• But these are mostly countries without Notified Bodies conducting conformity assessments.
• Milestone’s translators have extensive experience in the medical and healthcare industries, ensuring accurate and specialized translations.
• Since the disruption of the Mutual Recognition Agreement (MRA) between Switzerland and the EU, Switzerland is viewed as a third country and the EU MDR/IVDR do not apply directly.
• Consistent terminology is crucial for clear understanding of the instructions for use and thus for the safe and effective use of the device..

• A key aspect of EU MDR compliance involves translating all relevant documents into the official languages of the member states where you will market the products.
• According to the MDR, the instructions for use must be translated into the 24 official languages of the European Union, depending on the country or countries where the medical device is marketed.
• Labels are affixed directly to the device or, if it is not practicable or appropriate, on its packaging.
• Compliance with labeling requirements is essential to avoid product discontinuation and recalls.
• Labels of reagents that are intended as a replacement in a diagnostic system, may be limited to contain only the information necessary to adequately identify the reagent and to describe its use in the system.
• As a result, most medical device translation projects now include software localization—a process that involves extracting user interface (UI) strings, translating them into the target languages, and reintegrating them into the application.
• The European Union Medical Device Regulation (EU MDR) aims to ensure that medical devices manufactured in or supplied to EU member countries meet high standards of safety and quality.

A GUIDE TO MEDICAL DEVICE TRANSLATION AS PER EU MDR

Medical Device Labeling Standard: ISO 15223-1:2021

On the other hand, a label specifically refers to the written, printed, or graphic information that is displayed on the medical device itself. It is the visual representation of the information that is directly affixed onto the device. To meet the standards set by these national bodies, we employ only native-language experts with a solid medical background and a robust knowledge of regulatory affairs.

Guide to CE marking for medical devices under the EU MDR

A free and comprehensive guide to help you seamlessly navigate the new language requirements as per the European Medical Device Regulation. Any feedback provided will be seamlessly integrated into the files and languages, ensuring the final deliverables are precise. We have earned the trust of leading organizations worldwide to handle their language translation needs. Our team of experts is committed to delivering accurate and effective translations that exceed your expectations.

How Much Do IFU Translation Services Cost?

Therefore, take a user-centered approach and anticipate the context in which the device will be used such as clinical settings, home environments, or specialized care facilities, and tailor translations accordingly. The information management process requirements apply to all medical devices that are NOT consumer products.  accurate legal translation for contracts and compliance  labeling requirements for medical devices are more about what to communicate on labels, than containing requirements on what to put in the instructions for use. Accurate, certified translations are essential for FDA submissions, ensuring clarity, consistency, and regulatory compliance.

Checklist: eIFU Requirements in the EU

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To stay compliant, manufacturers should work with ISO-certified translation partners who understand regulatory standards, maintain version control, and ensure clarity for both professionals and patients. A strong translation process also supports EUDAMED readiness and simplifies multilingual updates throughout the product lifecycle. By utilizing these standardized symbols in medical device labeling, manufacturers can effectively communicate important information to users, ensuring safe usage and reducing the risk of errors or misunderstandings. Medical device labeling is crucial in the manufacturing process as it communicates vital information about the device’s benefits, risks, and safe usage instructions. Ensuring compliance with labeling regulations is paramount for manufacturers to gain market access and uphold patient safety. Section 23 of Annex I defines this information as the information needed to identify the device and its manufacturer, as well as any safety and performance information present on the device, its packaging, or in the instructions for use (IFU). There are 24 official EU languages, but you need to consider the language requirements only in the national markets where you place your device. Each EU Member State determines the language(s) it will accept at the national level through supplementary national medical device legislation and/or official guidance issued by its Competent Authority. Also, the label or labels on the device and on its packaging must be provided in the languages accepted by the member states where the medical device is envisaged to be sold. The standard's starting point is that if you want to ensure that users can use a product safely, efficiently and effectively, your information management process should meet certain requirements. There are C-type harmonised standards for all kinds of categories of medical devices, such as X-ray equipment, surgical luminaires and radiotherapy simulators, just to name a few. Actually, almost all medical products that we at INSTRKTIV deal with are electronic medical devices. And I will show you for both markets what the requirements are for medical devices as well as for in vitro medical devices.

Best Practices For Medical Device IFU Translation

Standards are being developed to define requirements for specific medical devices or groups of medical devices. The guidance aims to make medical device patient labeling more understandable to and usable by patients (or lay persons, such as family members caring for patients). It means, for example, that a manufacturer must keep a record that includes all device specifications, such as clear drawings, component specifications, software specifications, production process specifications and quality assurance procedures. Compliance with the requirements, if applicable, must ensure that finished medical devices are safe and effective.