In our evolving healthcare industry, it is essential to prioritize patient safety and communication. In Europe, the European Union—a political and economic collaboration between 27 countries—prioritizes medical safety and enhances communication by enforcing the European Union Medical Device Regulations. These laws must be followed by all medical device manufacturers aiming to sell their products in European markets.
Medical devices are categorized into four types:
- Diagnostic Devices: These are devices used to identify the root cause of sickness, like stethoscopes, thermometers, electrocardiographs (ECG), and X-ray machines.
- Therapeutic Devices: These devices assist in treating patients, like ventilators, defibrillators, and pacemakers.
- Monitoring Devices: As the name suggests, these devices monitor the vitals of a patient under observation, like blood pressure monitors and cuffs, pulse oximeters, and glucometers.
- Other Devices: These devices assist healthcare practitioners with auxiliary services, like biosensors, absorbent sutures, and catheters.
Due to Europe’s diverse linguistic and cultural landscape, it is essential to have accurate translations of all documents related to medical devices. This process is known as medical device translation.
In this blog, we will explore the importance of medical device translations and how they must adhere to the European Union Medical Device Regulations (EU MDR).
What Are Medical Device Translations?
As we have explored above, medical devices are extremely essential during the treatment of a patient. Furthermore, instructions and other documents that come with each medical device need to be accurately translated into many languages. To ensure this top-notch accuracy in multilingual medical device translations, assistance from professional linguistic agencies is essential.
Some important documents that frequently require medical device translations include:
- Clinical Evaluations: These are documents, like clinical trial reports and consent forms, that are derived from medical experiments on patients.
- Technical Documents: These documents include device details, manufacturer details, and safety manuals.
- Labelling and Instructions for Use (IFU): These documents—like user manuals, instruction guides, and device labelling—require the utmost clarity for the users (healthcare practitioners and patients).
Mistranslation of these documents can lead to severe misunderstandings, regulatory delays, or even patient distress. Hence, it is vital to ensure that these documents are translated by certified translation companies that provide flawless accuracy and comply with local laws.
Importance of EU MDR and Its Impact on Medical Device Translations
The European Union states that these medical device manufacturers must translate their products into 24 official EU languages. According to the laws set by the EU, it is essential to accurately translate medical device documents in all these 24 languages. Furthermore, these translations can only be handled by qualified and certified linguists and must adhere to the local laws of the target region.
As of 26th May 2021, the European Union Medical Device Regulation (EU MDR) has been completely enforced, influencing the way medical device manufacturers aim to sell their products in different European markets. Under the EU MDR guidelines, it is necessary to ensure that all medical devices comply with stringent linguistic requirements. Professional medical device translations are vital in meeting the linguistic criteria and ensuring that translations adhere to laws across EU countries.
What are the EU MDR Language Requirements?
Some language requirements set by the EU MDR are:
- Mandatory Translations in 24 EU languages: Manufacturers must provide all device information in all 24 EU languages. This includes common languages, like English and French, and uncommon languages, like Maltese and Lithuanian.
- Translations Must Have CE Marking: A CE marking is a certification that ensures the product complies with health, safety, and environmental standards set by the EU legislation. Translated documents and originals must carry the CE marking to be eligible for the market.
- Impact on Market Access: Without correct translations and a CE marking, manufacturers are not allowed to sell devices in the European markets—even if they adhere to other regulatory standards.
- Manufacturer’s Responsibility: It is the manufacturer’s responsibility to ensure the accuracy of translation. Hence, it is essential to choose the right linguistic agency.
- Additional Regional Languages: Some specific markets, like Catalan in Spain and Luxembourg in Belgium, would require additional translations into their regional language. Manufacturers selling in these markets must ensure these translations are done correctly.
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What Role Does Medical Device Localization Play?
We have explored what medical device translations are, but what about localization?
Localization is a process in which content is not just converted but adapted to meet the cultural and linguistic preferences of the target region. Medical device localization is vital to ensure that users—medical professionals and patients—completely understand the device’s functionality and its safety instructions. A top-tier localization service ensures the content of the medical device complies with region-specific regulatory requirements. A localized medical device builds trust between the manufacturers and users by providing relevant information in their native language to reduce misunderstandings. This enhances the quality of medical care provided across the EU nations.
Explore the importance of software localization in this blog: Software Localization: Your Guide to Global Success!
Role of a Certified Translation Company
Partnering with the right translation company is necessary to ensure that medical devices follow the EU MDR guidelines.
One must consider the following factors before choosing a linguistic partner:
- Medical Terminology Expertise: Medical device documents often contain complex terms. These terms must be accurately converted into the target language by experienced linguists with high medical knowledge.
- Quality Checks: A certified translation company implements several quality checks to ensure flawless accuracy. One such step is the double review translation This includes two rounds of translation and review by separate linguists to ensure the accuracy of every minute detail.
- Regulatory Standard Compliance: Medical device manufacturers must ensure the translations provided by the company are legally compliant with all laws set by the EU and other regulatory bodies.
Working with a professional linguistic agency is the ideal choice to maintain precision and legal compliance in all required documents. It also streamlines approvals, reduces delays, and enhances the efficiency of the product-to-market process. One such translation agency, Somya Translators, could be the perfect choice for manufacturers. We are an industry-leading, certified translation company in India with over 16 years of experience in medical translation services.
Our exceptional medical translation encompasses several industries:
- Hospitals and Healthcare Facilities
- Pharmaceutical Companies
- Health Insurance Companies
- Manufacturers of Medical Devices
So, if you are looking for immaculate linguistic support for the medical industry, then reach out to us, and together we can fulfil all your requirements.