Medical Device Translation: Ensuring Regulatory Compliance

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The critical nature of medical device translations

When it comes to translating documents for medical devices, precision is paramount. Imagine if a crucial instruction for use (IFU) or warning label were translated incorrectly, putting patients’ health and lives at risk. This example underscores the importance of accurate translation in the medical device industry. However, there are several challenges that companies face when having their medical device documentation translated. An understanding of technical documentation is one of the primary stumbling blocks. In addition to technical expertise, translators must also have an understanding of the regulatory environment as well as in-depth knowledge of the target market’s culture. It is only by combining all of these elements that medical device translations can be successful.


In this post, we’ll look at some of the unique challenges posed by medical device translations and provide some tips for ensuring accurate and high-quality translations that meet regulatory requirements and guarantee public safety.

The regulatory environment and translation requirements

The medical device industry is subject to a complex array of rules and regulations. Regulatory bodies like the Food and Drug Administration (FDA) in the United States and the EU’s European Medicines (EMA) have stringent requirements for documentation related to medical devices. And these requirements apply to translations as well. From product labeling to user manuals, specific documents must be translated precisely to ensure compliance with health and safety regulations. Failure to meet the relevant standards can affect regulatory approval and market access. This highlights the need for a thorough and comprehensive translation process carried out by a qualified language service provider.


While specific regulations vary depending on the medical device, some of the regulatory requirements that apply include:


  • US regulations: In the United States, medical device translations must comply with the requirements set forth by the FDA. This includes adherence to Title 21 CFR Part 801 for labeling and Title 21 CFR Part 820 for quality management systems In addition, the FDA requires “complete and accurate” translations of medical device documentation, including instructions for use, warnings, labels, and other documentation.


  • EU regulations: For medical devices marketed in the European Union, translations must comply with the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR), depending on the nature of the device. The MDR, which entered into force in 2021, expands the range of applicable medical devices to take account of new technological developments in this field. It is intended to ensure the safety and efficacy of medical devices, while also allowing the EU to remain competitive. The IVDR covers in vitro medical devices and entails stricter oversight of medical device manufacturers by notified bodies.


  • Other applicable standards: In addition to the regulations imposed by the FDA and the EMA, medical device manufacturers may also choose to adhere to ISO 14971:2019 and ISO 13485:2016, which relate to risk management for medical devices, including multilingual documentation, and quality management systems.


Other countries and regions may have their own regulatory frameworks governing medical device translations. It’s crucial for translation providers to understand these requirements to ensure the compliance of the translated documents in the relevant markets.

Common document types in medical device translation

There are many different types of documents in the medical device field. Following are some of the most common documents types found in medical device translation:


  • Instructions for use (IFUs): IFUs are essential documents that provide instructions on how to use a medical device safely and effectively.
  • Summary of safety and clinical performance (SSCP): This document summarizes the safety and clinical performance data of a medical device, providing important insights for regulatory authorities and healthcare professionals.
  • Product labeling: Labels on medical devices must contain essential information such as device identification, intended use, warnings, and instructions. Such labels must not only be accurate, but also comply with local regulations.
  • Regulatory documentation: This includes submissions to regulatory authorities for product approvals or clearances. Regulatory submissions may require translations of documents such as premarket approval (PMA) applications, 510(k) submissions, or CE marking documentation.
  • Quality management system (QMS) documentation: Manufacturers are required to maintain documentation related to their quality management system, including procedures, work instructions, and records.
  • Risk management documentation: Manufacturers must conduct risk assessments for their medical devices and document the results.
  • Clinical evaluation reports: For certain medical devices, clinical evaluation reports are required to demonstrate safety and performance.
  • Post-authorization surveillance documentation: This includes documentation related to monitoring the safety and performance of medical devices after they have been placed on the market.
  • Training materials: Manufacturers may provide training materials to healthcare professionals or end-users to ensure proper use of the medical device.
  • Notified body or regulatory correspondence: Any communication with notified bodies or regulatory authorities must be documented.


Regardless of the document type, however, it is important to translate them with care. Because these documents are used for purposes including regulatory approval, providing crucial usage information, and health and safety warnings, the translations must be accurate and precise.

The challenges of medical device translation

Medical device translation presents unique challenges. In addition to the technical complexity of these documents, which requires knowledge of highly specialized vocabulary, there are also cultural and linguistic nuances that need to be taken into account. Furthermore, ensuring consistency across multiple documents requires a meticulous translation management and quality control process. The key challenges include:


  • Understanding the technical complexity of a range of medical device documents
  • Being aware of the regulatory issues that may impact the compliance of medical device documentation
  • Having sensitivity to linguistic and cultural nuances of the target audience
  • The need for a robust quality control process involving a multiple reviews

Best practices for medical device translation

Translating medical device documentation accurately can be simplified by following some standard best practices. Some best practices include:


  • Terminology management: Establishing and maintaining device-specific, consistent terminology across all translated documents ensures clarity and accuracy.
  • Quality assurance: Implementing a rigorous quality assurance process, including multiple rounds of editing, to minimize errors and ensure translation accuracy.
  • Working with an experienced language partner: Select a partner with experience in the medical device field and established quality control processes. This will ensure the requisite level of expertise and a high-quality final product.


By adhering to these best practices, companies can overcome the challenges of medical device translation and ensure accurate, effective, and compliant translations that meet all of their needs.


For more than 40 years, GLS has partnered with pharmaceutical companies and medical device manufacturers to deliver the highest-quality, most accurate, and most reliable translations of technical and nontechnical documents related to medical devices.


Get in touch with us today to find out how we can help you with your medical device translations.

By Jim Cohen