Often, servicing is required for the safe and efficient functioning of a medical device. When a device requires installation and/or a test procedure before it can be used, the manufacturer of the device must provide adequate installation, inspection and test procedure instructions. Dates included on a device’s label like expiry dates and production dates must have the approved YYYY-MM-DD formatting, with Y representing the year, M representing the month, and D representing the date. It is considered to be important that a layperson receives adequate directions that enables him/her to use the medical device safely and according to its intended use.
EUDAMED Registration Webinar for MDR & IVDR
- The translation is essential for avoiding legal negative consequences, be it for the manufacturer or distributor of medical devices.
- It includes English summaries of national legislation and official guidelines from competent authorities, accompanied by clickable links to the official sources.
- Instructions for use are generally defined as the information a medical device manufacturer provides end users about the intended use of the device, its proper use, and any precautions they should take while using the device.
- As we’ve just seen that the date format of a medical article should have the form yy-mm-dd, for electronic devices, the place, month and year of manufacture should be mentioned.
- According to the CFR requirements, all required information must be in one place and in the format and order as specified in the requirements.
Your device UDI must be created by an accredited issuing entity and registered in a country-specific database, such as GUDID in the US or EUDAMED in the EU. Milestone performs detailed proofreading, formatting, and final review to deliver translations of the highest quality. Verify if they conduct linguistic, technical, and regulatory reviews by qualified translators, subject matter experts, and regulatory specialists to identify and address any errors or inconsistencies. In sectors like healthcare, even minor misunderstandings can pose serious risks, so thorough, clear IFU translations help maintain trust and minimize liabilities. It generally contains all the details regarding the operation, assembly/installation, maintenance/troubleshooting, and disposal of the product to educate and ensure that users clearly understand the usage of the product.
Why Instructions for Use Translation Is Critical for Compliance and User Safety
- Turnaround time depends on document complexity, language pairs, and regulatory requirements.
- The appendix includes a remark about the importance of following the care regimen as explained in the IFU and how it helps to motivate the user to obey the instruction.
- While many fundamental label requirements are the same, it’s important to review US and EU requirements carefully to ensure that you comply, particularly if your product carries device-specific label requirements.
- Medical device manufacturers often have multiple product lines, each with slight variations in features and applications.
- You can also add information on the importance of following the instructions and what the results and expectations are when the device fails, or the instructions are not followed.
The appendix includes a remark about the importance of following the care regimen as explained in the IFU and how it helps to motivate the user to obey the instruction. The appendix gives detailed additional information on definitions, purpose, content, format, location, etc related to warnings and precautions. General warnings and precautions are an integral part of risk and benefit information.
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Our linguists are experienced in medical software terminology and ensure translations meet both usability and regulatory standards. Marketing materials (including those provided on the manufacturer’s website) are not explicitly considered “information supplied by the manufacturer” in the national legislation of EEA countries and Turkey implementing the EU MDR and IVDR. However, national jurisdiction on medical device advertising and promotion may contain additional language requirements.
Importance of Medical Device Translation services
What do ”labelling” language requirements mean for manufacturers?
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. Certain terms in the medical device industry are governed by regulatory bodies and must be translated using specific official terminology. For instance, the use of H-phrases and P-phrases requires adherence to established translations to ensure compliance across the European Union. This also applies to any wording taken from the MDR, which has 24 official language versions.
What characteristics must a translation of instructions for use comply with?
Official regulation for translation
Marketing or promotional materials are not mentioned in the EU MDR or IVDR as part of the information to be supplied by the manufacturer. In principle, language requirements in the national legislation adopting the EU MDR and IVDR do not apply to them. They convey essential information about the device to the end user or the patient. Thus, SSCP and SSP must be written in a way that is understandable for the intended reader. You will need controls in place to ensure that even minor labeling revisions are accurately reflected across all languages. For native-language translators -risk or internal medical device content, MTPE (machine translation with post-editing) can be a cost-effective option. However, for high-risk, regulatory, or user-facing materials, we strongly recommend full human translation to ensure precision, compliance, and safety. Each project undergoes a multi-step review process, including checks for terminology accuracy and regulatory compliance with standards like FDA, EMA, and other regional authorities. We also conduct in-context reviews to ensure the translated content functions correctly and reads naturally within its final format. Unlike the information accompanying the device and the FSN, the EU declaration of conformity (DoC) is a regulatory document and does not contain any safety or performance information for the user. An image (an icon for saving) could also be used instead of the button, whose function would then be explained in the instructions for use (IFU). Implementing quick, accurate translations for documents like Instructions for Use (IFUs) which must be submitted before the CE (Conformité Européenne) marking that’s needed for conformity assessment. Submit documents and presentations in the correct formats to foreign regulatory authorities for consistent standards and effective approval. Milestone Localization Life Sciences is a specialized unit of Milestone Localization dedicated to providing translation services to organizations in the life science industry.
Why do medical devices need translation services?
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. Beyond making your application process seamless, you need accurate medical device translation for the following reasons. 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. ISO certified, 100% accurate, fit-for-purpose translations for your mission-critical projects. Instructions for use (IFU) are a critical part of the information that manufacturers are expected to supply to end users along with the device itself.
Question 7: How should we interpret the EU MDR language requirements for the graphical user interface (GUI)?
It is the responsibility of the manufacturer to provide instructions on how to service the device. But also, packaging and labeling specifications and installation, maintenance, and servicing procedures and methods. It is the duty of the person installing the device, to make sure that the installation, inspection, and any required testing are conducted according to the provided instructions. It mentions that manufacturers must establish and maintain procedures to ensure that ‘mixups, damage, deterioration, contamination, or other adverse effects to the product do not occur during handling’. This can be accomplished by putting a picture of the device on the cover of the product, including the product name, model, type, lot or batch number, or any other information to identify the product.