Medical Device Translation Requirements

Clear and accurate translations are essential for medical device manufacturers to ensure patient safety, support effective device usage, and meet regulatory standards around the globe. In the EU, these translation requirements are largely driven by the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), in which Article 10 (paragraph 11) of the MDR mandates that manufacturers provide documentation and labeling in the official languages where the device is marketed. 

This article will outline the key translation requirements under the EU’s MDR, including which materials must be translated and when. We will also explain why compliance is not just a regulatory formality, but a critical step in protecting users and maintaining market access in the EU and beyond. 

What Are The Requirements for Medical Device Translation? 

EU Regulations

Medical device translation involves converting essential product information, such as labels, instructions for use (IFUs), safety notices, and technical documentation, into the official language(s) of each European Union (EU) Member State where the device is marketed. 

This process ensures that healthcare professionals and patients can understand and use medical devices safely and effectively. Accurate translations are vital for patient safety, reducing the risk of misuse, and ensuring compliance with regulatory standards. 

US Regulations

Medical devices in the USA are regulated by the Food and Drug Administration (FDA). Although the FDA doesn’t require translations for all medical devices, materials sold in areas where people speak limited English may need to have their information translated. Also, documents used for clinical trials or sent to regulators may need to be translated so they can be properly reviewed.

What Medical Device Documents Require Translation?

• Technical documentation (TDs)
• Risk assessments (ISO 14971)
• Design validation & verification reports
• Design history files (DHF)
• Usability evaluations
• Clinical evaluation reports (CERs)
• Clinical trial protocols
• Patient recruitment materials
• Informed consent forms (ICFs)
• Patient information leaflets (PILs)
• Investigator brochures (IBs)
• eCOA/ePRO
• Regulatory submissions (e.g., FDA 510(k), MDR Applications)
• Lay summaries
• Instructions for use (IFUs)
• Unique device identification (UDI) labeling
• Post-market surveillance (PMS) reports
• Vigilance reports & adverse event reports (AERs)
• Complaint handling reports
• Device labeling updates
• Post-market clinical follow-up studies (PMCFs)

What Languages Are Accepted for Medical Devices in Each EU Member State?

To understand which languages are accepted for medical devices in the EU’s Member States, you will need to access up-to-date guidance, such as this table provided by the European Commission. This offers guidance for several different documents and elements, such as:

• Relevant Legal Provision (Reference and Hyperlinked to Official Publication)
• Label or IFU (Art. 10 (11), Annexe I, Section 23, MDR)
• Implant Card (Art. 18 (I) MDR)
• Declaration of Conformity (Art 19 (I) MDR)
• Field Safety Notice (Art. 89 (8) MDR)
• Documents for Conformity Assessment (Art. 52 (12))
• Graphical User Interface (GUI) 

What Are the New EU MDR Language Requirements?

There are three different levels of language requirements that medical devices are subject to in the EU, in compliance with the MDR: 

• EU Level: General language rules set out by the EU MDR 2017/745. 
• National Level: Specific language rules that are determined by the EU’s Member States.
• Device Level: Language rules particular to the device.

Accompanying information must be in the official languages of the EU countries where the device is sold. Annex I, Section 23 defines “accompanying information” as details needed for identification, safety, and performance, including on the device, packaging, and IFU. Although the EU has 25 official languages, you only need to translate into the languages required by the countries where your device will be sold. Each country sets its own rules, which may vary depending on factors like who will use the device (healthcare professionals or the public), what the content covers (e.g. safety), and the type of device.

How Do the EU MDR’s Translation Requirements Apply to Medical Device Software?

Although the MDR's General Safety and Performance Requirements (GSPRs) in Annex I place greater emphasis on user-friendly software interfaces than the earlier Medical Device Directive (MDD), it does not specifically address software localization. Instead, it relies on whether the GUI involves safety and performance information relevant to the user. If it does, it is categorized as “information supplied with the medical device” and, therefore, subject to the MDR’s regulatory requirements.

How Are Translation Requirements Enforced at National and Device Levels?

EU Member States have adopted different approaches to translation requirements for the GUI of medical devices, reflecting the absence of specific provisions in the MDR. These approaches generally fall into three categories:

1. GUI Treated as IFU

Some countries consider the GUI as part of the IFU, applying the same translation requirements and exemptions. In these cases, any safety and performance information presented via the GUI must be translated into the official language(s) of the respective Member State.

2. Risk-Based Translation

Other Member States allow manufacturers to perform a risk analysis to determine which elements of the GUI are essential for safe use. Only the identified critical content requires translation, while non-essential information may remain in the original language.

3. GUI Translation Not Required with National Language IFU

If a comprehensive IFU in the national language is provided with the device, the GUI itself may not need to be translated. This approach assumes that the IFU sufficiently covers all necessary information for safe and effective device use.

Who Can Translate Medical Device Content?

Under the MDR, there is no specific designation of who is "authorized" to translate medical device documentation. However, the regulation mandates that all translations must be accurate, clear, and suitable for the intended user. Therefore, it is recommended to use an ISO-certified provider like Conversis. We have stringent processes for reviewing and checking our work, ensuring the highest quality of translation and adherence to medical device regulations. 

How Is Medical Device Content Translated? 

Here is a step-by-step overview of how a professional provider translates medical device content. Please note that all translations should be done by certified and accredited professionals. 

1. Gather Comprehensive Product Information

Firstly, all relevant documentation related to the medical device is collected. This includes user manuals, technical specifications, product drawings, and any existing labeling. Understanding the device's functionality, usage, and technical details is essential in order to provide accurate translations.

2. Understand Regulatory Requirements

The translator must be familiar with the specific regulatory requirements of the target market and category of the device, ensuring the translations are compliant. As a summary:

• Medical devices marketed in the EU must have their IFUs, labels, safety notices, and technical documents translated into the official language(s) of each Member State where they are sold, as required by the MDR.
• Medical devices marketed in the USA are to be translated into English or other languages relevant to the target populations, under the Food and Drug Administration (FDA) standards.  
• Medical devices marketed in Canada, along with their IFUs and marketing materials, must be translated into both English and French, in compliance with Health Canada’s standards. 
• Medical devices marketed in China, along with supportive clinical data, must be translated into Simplified Chinese to comply with standards outlined by the State Food and Drug Administration (SFDA). 

3. Implement Quality Assurance Checks

After translation, thorough reviews should be conducted to ensure accuracy and consistency. This includes proofreading by a second linguist and, if possible, validation by subject matter experts. Quality assurance is vital to prevent misinterpretations that could lead to misuse or non-compliance.

4. Validate Translations with Regulatory Bodies

Before finalizing, ensure that the translated materials meet the approval of relevant regulatory authorities. For example, you must have a Marketing Authorization Application (MAA) submitted, as well as a declaration of conformity. The device must be submitted for acceptance before you market the product. If the device has been poorly translated, it will be refused, penalties may be imposed, and you may even be banned from marketing the device altogether. 

5. Ensure Clarity for End Users

Assess the translated materials for clarity and comprehensibility from the end user's perspective. This step is essential to ensure that healthcare professionals and patients can understand and correctly use the medical device; any confusion could lead to health and safety concerns. 

6. Prepare for Production and Distribution

Once translations are validated, proceed with printing and applying labels, updating digital interfaces, and integrating translated materials into packaging. Ensure that all translated content is correctly implemented across all platforms and formats. You must also include your country of origin and brand name, so that users know where the device comes from. 

7. Plan for Future Updates

Establish a process for updating translations in response to product modifications, regulatory changes, or feedback from users. Regular reviews and updates help maintain compliance and ensure ongoing user safety, especially in the event that regulations change. 

For More Information, Contact Our Life Sciences Translation Experts

Accurate medical device translations are an integral part of healthcare safety, and at Conversis, we ensure your devices and related materials are compliant with the correct regulations. Our team have been supporting clients around the globe since 2003, backed by ISO certifications 9001 and 17100 for quality and best practice, and 27001 for information security. 

Our linguists are native speakers, have extensive experience translating medical device documents and live in the relevant country, so they can offer accurate translations that take into account the nuances of the language and country. 

If you require a medical device translation service (or any other life science translations), we’re here to help. Simply get in touch with us today, and we’ll be more than happy to assist you.

get in touch