Medical translation plays an important role in assisting healthcare professionals in providing necessary treatment to their patients who speak a different language. According to EU data, there are more than 500,000 medical devices on the EU market. They range from diagnostic ultrasound to dialysis machines and even blood glucose meters.
Translation in the medical device sector is renowned for its attention to detail and accuracy, which makes perfect sense as a poorly translated instruction manual can have serious implications for the person using the device. This is one of the reasons why the European Union has decided to impose stricter regulations on medical devices – the Medical translation plays an important role in assisting healthcare professionals in providing necessary treatment to their patients who speak a different language., or European Medical Device Regulation. Read on to learn more about the importance of translation in the medical devices industry.Â
What is the MDR regulation?
The MDR regulation, which came into force in 2017, was originally intended to become mandatory in all European member states on 26 May 2020. However, the coronavirus pandemic has postponed its enactment by one year, setting the application date at 26 May 2021.  The MDR advocates a “life cycle model” approach, which aims to make medical device companies responsible for their products throughout their life cycle.
The regulation aims to strengthen labeling requirements, while also requiring labels to be translated into the language of the country where the product will be marketed. These new regulations aim to protect the European public by providing more transparent technical information on medical devices.
What is the role of translation in the medical devices industry?
Translation is a critical issue in the medical device industry. The MDR regulation requires that all content and documentation – including final Instructions For Use (IFU) and patient guides – are translated into the official language of the member state in which the device will be marketed. As a result, the documentation for medical devices will need to be translated into all 24 official EU languages.
This is a change for companies that previously translated their content into only a few languages of their choice. In addition, the regulation specifies that the content of medical devices must be written in a way that is easily understood by everyone, so it is important to work with expert translators who have experience in translating documents for the public.
Medical device documents for translation
In the medical device industry, the content to be translated is vast. To meet compliance requirements, a large portion of the materials must be translated and presented in the country’s native language. Intertranslations offers translation services for all types of medical device content, including design documents, manufacturing guides, operational instructions, compliance declarations, marketing, IFU, and manuals for medical device training.
Why assign the translation project to a professional translation agency?
In this specific field of medical device translation, our technical translators must have the right methods and tools for managing medical documents and vocabulary but must also be able to understand and translate the complex terminology of devices and the advanced techniques related to them.
By trusting a translation agency, you can count on true native professionals and experts in the field to carry out the translation, not to mention the professionals who will review the work and oversee the project. If you decide to work with a translation agency, you will also get continuous information on the progress of the project. You can contact a member of the agency at any time to find out what is new or to update the information.
ISO 17100 and 13485 certification for perfect medical device translation services
The translation of medical devices is a highly specialized field. On the one hand, it has its own jargon; on the other, it requires total confidence in intellectual property. By using an ISO 17100 certified translation agency, you can be sure that your translation will be carried out by experienced translators specialized in your field.
There is therefore no risk of ending up with documents that are approximate due to a lack of vocabulary in your sector. Furthermore, with strict and verified procedures, such an agency carries out one or more thorough proofreadings by both qualified linguists and professionals in your field who are proficient in the language(s) targeted by the translation.
Moreover, the medical equipment sector is, by definition, a sector that requires precision. ISO 13485 is a quality management system designed for medical devices. Medical device is a specialized term that has its own meaning within this standard. Any instrument, apparatus, device, machine, equipment, or reagent for in vitro use, as well as any computer program, material, or other similar or related article intended by the manufacturer to be used by people for sanitary purposes, is considered a medical device. If you outsource your translations, your translation provider needs to be certified for ISO 13485:2016.
Why choose Intertranslations
Intertranslations helps companies succeed globally by providing quality translation services for medical device manufacturers that not only meet their expectations, but also comply with local regulatory requirements. Quality medical device translation necessitates more than just linguistic and technical knowledge. This is due to the fact that the medical device industry is highly regulated, and quality language translation services must adhere to stringent regulatory guidelines, government directives, and strict technical documentation procedures in order to produce consistent, accurate, and regulatory compliant translations for IFUs, labeling, and user manuals.
ISO-certified translation agencies ensure consistent, high-quality translations by meeting a number of stringent criteria. Intertranslations’ medical translation efforts are thus held to international standards, since Intertranslations is ISO 17100:2015 and ISO 13485:2016 certified. We understand that as a medical device manufacturer, you want to get your products and technologies to market as soon as possible. We therefore guarantee excellent results within a tight timeframe. This way, you spend less time on your medical translations and more time on marketing your products.
Conclusion
Translation of medical devices is a very specific, complex and high-stakes type of translation. Incorrect translations can not only cause your international product launch to be delayed, but they can also result in millions of euros in damages. Intertranslations’ certified medical translation service provides absolute precision and linguistic quality you can rely on, allowing you to effectively manage global regulatory risk and communicate confidently with international customers, physicians, doctors and patients worldwide.
