By taking proactive measures, manufacturers can meet EU MDR requirements and deliver safe medical devices efficiently. By mastering proper labeling practices, manufacturers can enhance patient safety, strengthen their position in the competitive medical device market, and avoid the severe consequences of non-compliance. Instructions For Use are an important document accompanying medical devices vital to not just the intended users but also necessary to comply with various rules and regulations. Native translators with subject matter expertise and a minimum of 4 years of experience in translating medical device documents work on translating the documents under the guidance and instructions of the dedicated project manager.
How to improve LEP patient scheduling experiences
Familiarize yourself with the regulatory requirements for medical device documentation in the target markets, including language requirements specified by regulatory agencies such as FDA, EMA, and EU MDR. They enable real-time updates, better accessibility, and compliance with global regulations. However, accurate eIFU translation remains a complex challenge that affects patient safety, compliance, and global market access. The primary information required includes product details such as labeling, packaging, and Instructions for Use (IFU).
Translation Requirements for Medical Device Labeling
These are not insurmountable challenges, but they do provide some context for laws like the FD&C Act, which require manufacturers to offer paper alternatives when requested. The MDR makes no explicit reference to the graphical user interface (GUI) of a device. In this blog post, we will explore the importance of Medical Device Symbols for Labeling and highlight some essential symbols commonly used in the industry. As far as regulators are concerned, any direct or implied assertion about your product, whether it’s in an ad or a social media post – and whether it was made by someone at your company or not – can be considered a claim.
- This requirement increases the volume of translation work and can be challenging when you are on a tight deadline.
- In addition, in Section 20.4.2, the IVDR also sets out rules for the IFU supplied with in vitro diagnostic devices intended for self-testing.
- Indicates a medical device that should not be used if the package has been damaged or opened and that the user should consult the instructions for use for additional information.
- Accelerate your medical device approvals with our specialized medical device translations.
- Ensuring a high standard of safety and quality for medical devices in Europe is the responsibility of the manufacturer.
- We also follow ISO practices related to quality management for medical devices, aligning with the strict requirements of regulatory bodies.
- In some cases, translated IFUs may need to be published in a single booklet that includes instructions in as many as 30 different languages.
Expert Medical Device Translations for Global Market Access
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.
How Does the MDR Differentiate Between Instructions for Use and the Label?
If appropriate, include information on extended storage in relevant sections, such as the installation/setup, checkout, operation, or maintenance section. Sometimes, a device requires checkout procedures for the sake of safety and effectiveness. The ANSI Z535.6 standard distinguishes directional safety instructions (such as “READ ALL INSTRUCTIONS BEFORE USE”), grouped safety messages, sectional safety messages and embedded warnings. Besides instructional information, such as operation instructions and maintenance instructions, the IFU often needs to include descriptive information.
Field safety notices (FSNs)
Ask for references or case studies to see how the provider has handled large-scale translation projects in the past. Look for examples where they have successfully translated IFUs, clinical trial documents, or product catalogs into multiple languages for well-known medical device companies. This can give you confidence that the provider is equipped to handle your translation needs effectively. Common challenges in localizing medical device software include ensuring that the translated UI remains intuitive and that technical terminology is accurately translated. Aqueduct linguists with expertise in software localization can help streamline this process by ensuring that the localized software is both functional and culturally appropriate. In certain fields such as medical and medical devices, IFUs are not only informative but also legally required.
Medical Devices Translation Services
- You can include a section ‘Complaints’ (or any other meaningful name) which includes the company’s postal address, telephone number and email address.
- If you are looking for a good example of an IFU for medical devices, try using our ifu medical device template.
- When selecting a translation provider, it’s important to evaluate their experience with medical device projects.
- For example, diagnostic devices, such as a glucose monitor, mostly generate a certain output.
- Don’t delay – start preparing for EU MDR compliance today with the expertise of MedDev Experts.
- Beyond meeting regulatory requirements, translating product information ensures doctors, nurses, and patients worldwide fully understand how to operate sophisticated medical equipment.
- They serve as essential reference tools for linguists, ensuring that specific terminology is consistently applied across all translations.
- Translation of IFUs requires extreme attention to detail and a thorough understanding of the subject matter, technical terminology, and a comprehensive understanding of the context.
Maintaining quality and consistency is significantly important while translating IFUs. It is important to check with the language service provider about their quality assurance process before starting the translation process. Medical device manufacturers aiming to enter international markets must translate IFUs into the languages spoken in those markets. We translate eIFU content and ensure it’s properly localized for digital platforms, meeting both usability and MDR regulatory requirements for electronic delivery formats.
What are the requirements for medical device translations?
For example, diagnostic devices, such as a glucose monitor, mostly generate a certain output. Based on this information, the practitioner accordingly needs to decide whether to use or not use a certain device, or make a selection between available devices for the treatment, prevention, or diagnosis of an illness. First of all, it should assist manufacturers in the development of the instructions for use. Basically, this means that you may want to provide some directional safety messages in your instructions for use. Incorporating symbols into medical device labeling is a powerful way to improve user understanding and promote safety. By following international standards and conducting risk analysis, medical device manufacturers can create labels that are informative, universally recognizable, and ultimately contribute to better patient outcomes. Regulatory authorities such as the EU require medical device manufacturers to provide translated Instructions for Use (IFU) in the local language.
Example of Medical Device Label with Symbols
This interpretation aligns with the information published by the European Commission in January 2024. In response to the MDR, only 16 European countries have specifically addressed language requirements for the user interface, which covers the GUI. However, ensuring the accuracy and clarity of your IFU in all language versions is essential for patient safety and the prevention of in-use errors. According to the MDR Annex I, Section 23.1(a) “instructions for use shall be written in terms readily understood by the intended user”. Remember, using clear and concise symbols on medical device labels not only enhances usability but also demonstrates the manufacturer’s commitment to user safety and satisfaction. Complying with device labeling requirements calls for meticulous attention to detail.
The Language Industry
When one or more standards apply to an electronic device, the manufacturer must make sure that the dealer receives a certification that the device meets the applicable standard(s). General warnings and precautions cover all specific hazard information that a user needs to be aware of before using a medical device. Also, risk/benefit information helps to determine what the possible effect of a medical device on the patient may be. Once Congress has enacted a law, the appropriate federal agency may create the regulations or rules to implement the law. Countries in the European Union dictate that the proper translation of instructions of use is a mandatory requirement. Talk to our team of experts to see how MedEnvoy can propel your business into new markets. According to Article 10(11) this information must be in all the language versions accepted in the national markets where the device is made available to the user or patient. For professional guidance and assistance in developing your medical device labels and complying with the EU MDR labeling requirements, consider partnering with MedDev Experts, a leading medical device regulatory consulting company. Our team of experts can provide tailored consultancy services to support you throughout the compliance journey. Back translation is the process of translating a document back into its original language to verify accuracy.